Mean Number Of Injections Research Articles

P-560. Evaluating the Use of Long-Acting Lenacapravir among Treatment-Experienced Adults with HIV in a Large Community-Based Clinic Network

Abstract Background Lenacapravir (LEN) is the first-in-class long-acting capsid inhibitor approved by the FDA in December 2022 for the treatment of multi-drug resistant HIV in adults. It is administered by subcutaneous injection every six months in combination with other antiretrovirals (ARV). It is indicated for heavily treatment-experienced people with HIV (PWH). We assessed the use of long-acting LEN within the CAN Community Health Network. Methods A retrospective analysis of electronic medical records within the CAN Community Health Network of 23 clinics located throughout six US states. People with HIV who received one or more injections of LEN for treatment between December 2022 and April 2024 were included. Demographic characteristics, HIV viral load, CD4 count and composition of pre-LEN ARV regimens were studied. Results Twenty-four PWH were identified as receiving one or more injections of LEN between December 2022 and April 2024. The median age was 58 years; 79% were male, 67% White and 71% Non-Hispanic (Table 1). Mean number of injections received was 2. Pre-LEN HIV VL was >50 copies/mL in 8 PWH (33%) and pre-LEN HIV VL was < 50 copies/mL in 16 PWH (67%). Five PWH (21%) had a pre-LEN CD4 count < 200 and 19 PWH (79%) had a pre-LEN CD4 count >200. Post-LEN HIV VL decreased in all eight patients with HIV VL >50 copies/mL (Table 2). Pre-LEN ARV regimens included a median of 4 active agents with 92% of them containing integrase inhibitors (INSTIs), 71% NRTIs and 58% protease inhibitors (PIs) (Table 3). Reasons for switching to a LEN-combination regimen in those with HIV VL < 50 included: simplification, side effects or intolerance to oral ARVs and non-adherence. Three (13%) patients stopped LEN due to injection site reactions (ISRs), 1 patient (4%) stopped due to side effects, 2 patients (8%) were lost to care and 1 patient (4%) was switched to an oral alternative due to travel. Conclusion The majority of PWH who were switched to LEN-combination regimens were older males with HIV VL < 50 copies/mL. Reasons for switching included simplification, side effects to other ARVs and non-adherence. Of those with HIV VL > 50 copies/mL prior to switching to a LEN-combination regimen, all had a decrease in their HIV VL. The most common reason for discontinuation was ISRs. Sample size was small and a longer duration of follow-up is needed. Disclosures Jessica A. Altamirano, MD, FIDSA, Gilead Sciences: Speaker's Bureau

Innovator ranibizumab ComparEd to Biosimilar ranibizumab in combination with Expansile gas in submaculaR HemorrhaGe: the ICEBERG study

PurposeTo compare the anatomical and visual outcomes in eyes with submacular hemorrhage (SMH) treated with a combination of ranibizumab (RBZ) either innovator or biosimilar (Razumab) and intravitreal perfluoropropane gas (C3F8).MethodsTreatment naïve neovascular age related macular degeneration (n-AMD) patients with SMH were retrospectively analyzed. Patients received either innovator or biosimilar RBZ (3 loading doses followed by pro re nata regimen) and single injection of intravitreal C3F8. Optical coherence tomography (OCT) was performed at baseline, 1, 3 and 6 months. Changes in best corrected visual acuity (BCVA) and central macular thickness (CMT) were assessed at 6 months. P value ≤ 0.05 was considered statistically significant.ResultsA total of 67 eyes (35 and 32 eyes in innovator and biosimilar group respectively) were analyzed. BCVA improved from 1.15 ± 0.19 to 0.51 ± 0.23 logarithm of minimum angle of resolution (logMAR) in innovator RBZ group (p < 0.001) and from 1.17 ± 0.15 to 0.53 ± 0.20 logMAR in biosimilar RBZ group (p < 0.001). Similarly, mean CMT showed significant reduction in both groups at 6 months (innovator RBZ: 609.5 ± 50.1 μm to 254.3 ± 20.3 μm, p < 0.001; biosimilar RBZ: 602.3 ± 58.9 μm to 251.8 ± 22.3 μm, p < 0.001). Intergroup comparisons between innovator and biosimilar RBZ showed no differences in either BCVA or CMT at all time points (all p values > 0.05). Mean number of intravitreal injections was marginally higher in innovator group compared to biosimilar RBZ (4.37 ± 0.49 vs. 4.22 ± 0.42; p = 0.18).ConclusionBiosimilar RBZ may act as a viable alternative to innovator RBZ to treat SMH with comparable anatomical and visual outcomes at 6 months.

A combination regimen of Intravitreal clindamycin with dexamethasone, systemic co-trimoxazole and steroids for macular Toxoplasma retinochoroiditis in immunocompetent cases.

To study the role of intravitreal clindamycin with dexamethasone as an adjuvant to systemic co-trimoxazole and steroids in macular Toxoplasma retinochoroiditis. Retrospective study of Toxoplasma retinochoroiditis cases from January 2014 to December 2021 treated with a combination of oral and intravitreal therapy in immunocompetent patients. 39 eyes of 39 patients were included in this study after meeting the inclusion criteria with the mean age of presentation being 25.25 years (± 9.30; range 4-52 years). Male preponderance with 61.53 % of males (n = 24) and 38.47% of females (n = 15) was observed. Active retinitis was unilateral in all eyes (20 right eyes; 19 left eyes). Five lines of improvement in vision acuity on ETDRS chart were noted at final visit. The location of retinitis was either foveal (n=24) or extrafoveal (n=15). The mean size of retinitis was 1.24 ± 0.70-disc diameter. The mean number of injections given was 1.79 with a mean interval of 1.39 weeks. Intravitreal clindamycin with dexamethasone when used as an adjunct to systemic therapy showed resolution of retinitis in all cases with visual improvement.

Initial experience with brolucizumab for neovascular age-related macular degeneration (nAMD) in India - Multicentric, real-world study.

To evaluate the anatomic and visual outcomes and safety profile of initial Indian eyes with neovascular age-related macular degeneration (nAMD) treated with intravitreal injection (IVI) of brolucizumab. This retrospective multicentric, real-world study enrolled consecutive eyes with nAMD that were treated with IVI brolucizumab after it was launched in India in October 2020. Data collected for each eye included best-corrected visual acuity (BCVA), central subfield thickness (CSFT), subretinal fluid (SRF), and intraretinal fluid (IRF) status at 6, 12, and 24 months follow-up. Also recorded were the lens status, treatment protocol, number of injections received before enrollment (in switch-over cases), total number of injections, and adverse effects noticed during the study period. Primary outcomes were change in BCVA, CSFT at follow-up visits, and incidence of intraocular inflammation (IOI). Secondary outcomes were profile of macular neovascularization, treatment protocols, mean number of injections, and maximum injection-free interval observed in eyes treated by pro-re-nata (PRN) protocol. In total, 331 eyes received a mean of 3.55 ± 1.83 injections. Most frequent treatment protocol was PRN (53%). BCVA data was available for 100%, 96%, and 74% eyes at 6, 12, and 24 months follow-up. BCVA and CSFT improved significantly (P < 0.001) at all follow-ups. Two hundred and seventy-six (83.38%) out of 331 eyes received more than one injection; out of these, 241 (87.3%) eyes that were treated by PRN protocol could achieve mean "maximum injection-free interval" of 19.43 ± 8.82 weeks. IOI and retinal vasculitis were reported in 2.11% (7/331) and 0.60% (2/331) eyes, respectively. None of the eyes with IOI or vasculitis lost any vision at the final follow-up. This study demonstrated favorable visual and anatomic outcomes and safety profile for eyes with nAMD treated by IVI brolucizumab. Mean maximum injection-free interval in eyes treated with PRN was 19 weeks.

Local Betamethasone Versus Triamcinolone Injection In Management of Thyroid Eye Disease-Related Upper Eyelid Retraction With Proptosis.

To compare the efficacy of local injection of both betamethasone and triamcinolone in the management of thyroid eye disease-related upper eyelid retraction with proptosis. This prospective, double-blind, randomized clinical trial was conducted at Assiut University Hospital, Upper Egypt in the period between December 2021 and December 2023. The study included 45 patients (77 eyes) and was divided into: A (betamethasone) group and B (triamcinolone) group. The steroid was injected peri-levator (1 ml) and retrobulbar (1.5 ml). The injection was repeated every month for up to 5 injections if there was an improvement in margin reflex distance 1 (MRD1) and Hertel measurements. The injection was stopped if measurements reached the normal value or if 2 successive injections caused no improvement. The postinjection outcome was divided into; 1) effective if measurements reached the normal (MRD1 ≤4.5 mm and Hertel ≤18 mm); 2) partially effective if measurements were improved but did not reach the normal; and 3) ineffective if there was no improvement in measurements. The follow-up ranged from 6 to 20 months. In group A, the injection was effective in 35 eyes (89.74%) and partially effective in 4 eyes (10.26%). In group B, the injection was effective in 22 eyes (57.9%), partially effective in 8 eyes (21.05%) and ineffective in 8 eyes (21.05%). The mean injection number was significantly lower in group A than in group B; 2.54 ± 0.51 versus 3.74 ± 1.18. This study's results suggest that betamethasone is more effective with a small number of injections than triamcinolone in the management of thyroid eye disease-related upper eyelid retraction with proptosis.

Real world treatment outcomes in polypoidal choroidal vasculopathy in a Caucasian population of British ethnicity.

To assess treatment response of Polypoidal choroidal vasculopathy (PCV) in a Caucasian population of British ethnicity with intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections alone and with a combination of anti-VEGF injections and photodynamic therapy (PDT). Department of Ophthalmology, University Hospital Southampton NHS Foundation Trust, United Kingdom. Retrospective review of 95 Caucasian patients in a single centre with diagnosis of PCV between 2013 and 2018 were included. Best corrected visual acuity (BCVA), central retinal thickness (CRT), indocyanine green angiography (ICGA) characteristics, numbers and type of treatment were analysed at baseline and at 1 year. One hundred and one eyes included from 95 patients received either anti-VEGF injections (n = 79, 78.2%) alone or combination therapy with anti-VEGF and PDT (n = 6, 6%). A third untreated group was also observed (n = 16, 15.8%). Five eyes were excluded from the study due to structural retinal damage. Mean number of injections was 7.3 in the monotherapy group and 6.5 in the combination group. Both treatment groups showed improvement in BCVA at 1 year and this was statistically significant in the monotherapy group with a mean gain of 8.3 letters (p < 0.001). Mean CRT decreased in all treatment groups at twelve months and this change was significant (p < 0.01). In the observation group, vision and CRT remained stable. This study demonstrates significant improvements in BCVA at one year in our Caucasian cohort of British ethnicity with PCV in the treatment group.

Oral invasive procedures in Glanzmann thrombasthenia: a retrospective observational study

BackgroundGlanzmann thrombasthenia (GT) is a very rare autosomal inherited bleeding disease affecting megakaryocyte lineage with impacts on oral health such as gingival bleeding, which requires specific management protocols. Very few clinical cases have been published in the dental and hematologic literature. ObjectivesThis study focuses on a series of 21 patients affected specifically by GT and their hemorrhagic prophylaxis management with the use of recombinant activated factor VII (rFVIIa) for dental extractions and full-mouth debridement. MethodsData were collected from medical and dental records. rFVIIa was administered prophylactically for oral procedures, following a standardized protocol. Each sessions were performed by experienced oral surgeons, and outcomes were analyzed with a focus on bleeding complications and adverse events. ResultsForty-one full-mouth debridements and 176 dental extractions were performed during 102 sessions of dental care in an outpatient setting. A total of 226 injections of rFVIIa was delivered. The mean number of injections was 2.2 (range, 1-4) per dental procedure. The overall rate of bleeding complications was 5.9% (n = 6). All 6 hemorrhagic complications were classified as minor bleeding. No thromboembolic event or allergic reaction was observed. ConclusionThe data presented in this retrospective observational study support the efficacy and safety of rFVIIa for the prevention of bleeding during invasive dental procedures in patients affected by GT. The rFVIIa protocol presented here seems to be a safe and efficient protocol for the prevention of bleeding during invasive oral procedures.

Factors influencing surgical treatment of De Quervain's tendinopathy: A retrospective cross-sectional observational study

BackgroundThe literature surrounding how different patient, sociodemographic, and anatomical factors influence surgical treatment of De Quervain's tendinopathy (DQT) is limited. PurposeWe hypothesised that different patient, anatomical, or sociodemographic factors influence the management of DQT with regard to non-operative vs. surgical management. MethodsThis retrospective cross-sectional study reviewed 155 cases of patients with DQT seen over a 10 year period. Patient-specific factors included age, gender, hand affected, dominant hand, steroid injection given and mean number of injections. Sociodemographic factors included ethnicity, employment, and deprivation, were measured using deprivation quintiles through The Index of Multiple Deprivation. Anatomical factors included the presence of subcompartmentalization, number of APL and EPB tendon slips, tendon thickening, exudative tenosynovitis, hypervascularization, and the presence of a sheath ganglion Patients were categorized into either non-operative or surgical cohort. Bivariate analysis was used to compare factors between the cohorts, and significant factors (p < 0.05) were included in the logistic regression model, used to predict factors influencing surgical management. ResultsBivariate analysis detected a significant difference in the mean number of steroids given between the non-operative and surgical cohort (p = 0.001) patient factors. For sociodemographic factors, a significant difference was found between deprivation quintiles (p = 0.02). From the anatomical factors, the surgical cohort had more patients with multiple APL tendon slips (p = 0.02) and the presence of a tendon ganglion sheath ganglion (p = 0.02). For patient and sociodemographic factors, logistic regression identified that the number of steroids (per patient) and being in deprivation quintile 4 were associated with surgical treatment. For anatomical factors, multiple APL tendon slips and the presence of a tendon sheath ganglion were associated with the surgical treatment. ConclusionThis study suggests that several factors are associated with the need for surgical treatment of DQT, including the number of steroid injections received, social deprivation, and anatomical factors, such as the presence of multiple tendon slips and a tendon sheath ganglion. Our findings add to the growing body of literature exploring factors that may influence treatment pathways for patients with DQT.

Modified pro re nata regimen of brolucizumab in treatment-naive neovascular age-related macular degeneration.

Purpose- To study the efficacy and safety of pro re nata regimen of brolucizumab, without loading dose, in treatment-naive patients with neovascular age-related macular degeneration (nAMD). Case series- Retrospective, observational study. We included all consecutive patients diagnosed with treatment- naïve nAMD undergoing Brolucizumab in Humanitas eye clinic, Turin, Italy between April 2022 and May 2023. Treatment was performed following pro re nata regimen without loading phase. Injection intervals (time between two injections), adverse events, changes in best corrected visual acuity (BCVA), central macular thickness (CMT), maximal retinal thickness (MRT), intraretinal and subretinal fluid (IRF, SRF) were evaluated descriptively up to one year after the first injection. Twenty-one eyes of 21 patients were included in the study. The mean number of injections was 2.4±0.7 at 3 month, 3.0±2.0 at 6 month, 3.1±2.4 at 9 month and 3.8±2.8 at 12 month, respectively. BCVA significantly improved from 20/80 Snellen (0.6±0.3 LogMar) to 20/50 Snellen (0.4±0.3 LogMar) at month 12 (p = 0.044). CMT and MRT significantly reduced from 426 μm and 606 μm at baseline, to 248 μm and 356 μm at one-year follow-up (p=0.00067 and p=0.02, respectively). SRF and IRF also progressively resolved. On the other hand, intraocular inflammation (IOI) events occurred in 9.5% of cases during follow-up. IOI resolved in all cases with prompt treatment without visual sequelae. Conclusions- In our study, pro re nata regimen of brolucizumab without loading phase appears to be an effective treatment option in treatment-naive nAMD patients, with IOI rate similar to the one reported in trials and lower number of injections.

Dexamethasone implant in naive versus refractory patients with diabetic macular edema: a Meta-analysis.

To evaluate the efficacy and safety of the intravitreal dexamethasone implant in naive and refractory patients with diabetic macular edema (DME). PubMed, Embase, Web of Science, and Medline databases were searched. The main outcomes were best-corrected visual acuity (BCVA) and central retinal thickness (CRT). The secondary outcomes included mean number of injections, intraoperative or postoperative complications including intraocular pressure (IOP) elevation and cataract. Ten comparative studies involving a total of 1000 DME eyes including 402 naive eyes and 598 refractory eyes were selected. The postoperative BCVA in the naive group was significantly better than in the refractory group [mean difference (MD) -0.11, 95% confidence interval (CI) -0.17 to -0.05, P=0.0003; MD 8.69, 95%CI 5.08 to 12.30, P<0.00001)]. Additionally, the naive group got greater improvement of BCVA change as well as more gains of BCVA letters than the refractory group [MD 7.71, 95%CI 2.02 to 13.40, P=0.008; odds ratio (OR) 2.99, 95%CI 2.05 to 4.37, P<0.00001]. The subgroup analysis revealed that the naive group had significantly higher BCVA gains of ≥5, ≥10, and ≥15 letters compared to the refractory group (P=0.002, 0.0001, 0.003, respectively). No significant difference was detected between the two groups in either postoperative CRT (MD -22.36, 95%CI -46.39 to 1.66, P=0.07) or the overall mean number of injections (MD -0.08, 95%CI -0.38 to 0.22, P=0.61). Intraoperative and postoperative complications including the elevation of IOP (OR 0.47, 95%CI 0.20 to 1.13, P=0.09) and cataract (OR 1.78, 95%CI 0.97 to 3.24, P=0.06) showed no significant differences between the two groups during the follow-up time. Intravitreal dexamethasone implants for DME can improve anatomical and functional outcomes in both naive and refractory eyes and have a well-acceptable safety profile. Moreover, naive eyes maintain better visual outcomes than refractory eyes. It provides further evidence of better visual response when used for naive eyes as first-line therapy.

Reactivation of stable neovascular age-related macular degeneration following treat-and-extend regimen discontinuation.

To describe the incidence and pattern of reactivation of neovascular age-related macular degeneration (nAMD) following successful treatment with treat-and-extend intravitreal anti-vascular endothelial growth factor therapy. Consecutive patients with treated nAMD who did not require further treatment over a 6-month period and who attended their 3-monthly optical coherence tomography monitoring clinic in Moorfields Eye Hospital from 1 November 2019 to 31 January 2020 were included. Patients with diagnoses of macular neovascularization other than AMD, and patients with incomplete data were excluded. Baseline demographics recorded were age, sex, race, laterality, cause of macular neovascularization, drug, number of injections, and duration of treatment. Date, setting, symptoms, and time to retreatment were collected among patients with disease reactivation. The medical records of 286 patients were included. Most patients were female (64.3%), white (68.18%), and were receiving aflibercept monotherapy (55.2%). Mean number of injections at baseline was 17.79 ± 11.74 (range 3-62) with a mean treatment duration of 39.47 ± 30.68 months (range 2-139). Reactivation of AMD was identified in 32.2% of cases with 87% of recurrences identified via scheduled visit. The most common symptom was blurring of vision in 44.6%, while 39.1% were asymptomatic. Mean time from baseline to retreatment was 29.37 ± 22.40 months (range 5-104), with 20.7%, 73.9% and 88.04% of these patients requiring retreatment within 1, 3, and 5 years, respectively. Despite prior treatment with no reactivation in 6 months, 32.2% reactivate, 73.9% of which within 3 years. A significant proportion, 39.1%, reactivated without symptoms necessitating regular monitoring in the first 5 years.

Efficacy and Safety of an Indian Bevacizumab BIOSimilar (BEVATAS) for Retinal Vein Occlusion (BIOS-RVO Study).

To evaluate the efficacy and safety of Bevatas®, an Indian bevacizumab biosimilar, in the management of both Central Retinal Vein Occlusion (CRVO) and Branch Retinal Vein Occlusion (BRVO) (BIOS-RVO). The BIOS-RVO study was a retrospective interventional study conducted at a single tertiary eye care facility in India. 154 treatment-naïve eyes with RVO (CRVO: 62 eyes; BRVO: 92 eyes) received intravitreal bevacizumab biosimilar (IVBb) therapy. Data on best-corrected visual acuity (BCVA), central macular thickness (CMT), and intraocular pressure (IOP) were collected at baseline and at 3, 6, and 12 months post-therapy. The average age of participants was approximately 55.99 (+12.56) years, with a nearly equal gender distribution (M:F = 49.4:50.6). Age differences between BRVO and CRVO groups were not significant (P=0.501), but gender distribution varied significantly (P=0.035), with more males in the CRVO group. Significant improvements in BCVA were observed in both CRVO and BRVO groups at 3 months, 6 months, and 1 year compared to baseline (P<0.001). Both groups showed significant reductions in CMT throughout the follow-up period (P<0.001). The mean number of injections was higher in the CRVO group (5.27[±1.45]) compared to the BRVO group (4.27 [±1.28]) (P<0.001). Significant IOP increases were observed at 1 month (P<0.001) and 6 months (P<0.001) in both BRVO and CRVO groups, although not clinically significant. Safety analysis revealed no additional ocular or systemic adverse events during the study period. The BIOS-RVO study demonstrates that Bevatas is an effective and safe treatment option for both CRVO and BRVO. These findings support the use of Bevatas as a cost-effective alternative to branded anti-VEGF agents, particularly in resource-limited settings.

Vitreoretinal Interface Abnormalities in Patients With Retinal Vein Occlusion in a Tertiary Referral Center.

The purpose of this study is to investigate the prevalence of vitreoretinal interface (VRI) disorders in patients with retinal vein occlusion (RVO) and to evaluate the impact of VRI abnormalities on the treatment outcomes of macular edema secondary to RVO using intravitreal aflibercept. Participants in this prospective study were consecutive patients with macular edema secondary to RVO, who received intravitreal aflibercept injections. At baseline, best-corrected visual acuity (BCVA) was assessed, and spectral domain-optical coherence tomography (SD-OCT) was performed to measure central subfield thickness (CST) and to evaluate the presence of VRI disorders, namely, vitreoretinal adhesion (VMA), vitreoretinal traction (VMT), epiretinal membrane (ERM), lamellar macular hole (LMH), and full-thickness macular hole (FTMH). The primary outcomes were the prevalence of various VRI disorders in patients with RVO and the impact of VRI disorders on BCVA and CST after aflibercept treatment in such patients. At baseline, 16.1% of patients had VMA, 3.2% VMT, 18.3% ERM, and 1.1% LMH. There were a statistically significant improvement in BCVA and a decrease in CST in RVO patients over time. There was no statistically significant difference regarding BCVA and CST at baseline and until month 24 after treatment between patients with VRI disorders and those without VRI disorders. However, the mean number of injections during the follow-up period was higher in the group with VRI disorders (9.4±2.1) compared to those without VRI disorders (8.1±0.7, p=0.0002). The prevalence of VRI disorders in patients with RVO was 16.1% for VMA, 3.2% for VMT, 18.3% for ERM, and 1.1% for LMH. VRI disorders were not found to affect the anatomical and visual outcomes after intravitreal aflibercept treatment in patients with RVO, although more intravitreal injections were needed in patients with VRI disorders.

Peri-levator Betamethasone Versus Triamcinolone Injection in Management of Thyroid Eye Disease-related Upper Eyelid Retraction Without Proptosis.

To compare the efficacy of peri-levator injection of both betamethasone and triamcinolone in the management of thyroid eye disease-related upper eyelid retraction without proptosis. This prospective, double-blind, randomized clinical trial was conducted at Assiut University Hospital, Upper Egypt in the period between December 2021 and October 2023. The study included 47 patients (56 eyes) and was divided into 2 groups. In group A, 1 ml betamethasone was injected into the peri-levator area, while in group B, 1 ml triamcinolone was injected. The injection was repeated every month for up to 5 injections if there was an improvement in margin reflex distance 1 (MRD1). The injection was stopped if MRD1 reached the normal value or if 2 successive injections caused no improvement in MRD1. The postinjection outcome was divided into: 1) effective if MRD1 reached the normal ≤4.5 mm; 2) partially effective if MRD1 was improved but did not reach the normal; and 3) ineffective if there was no improvement in MRD1. The follow up ranged from 6 to 20 months. In group A, the injection was effective in 26 eyes (92.9%) and partially effective in 2 eyes (7.1%). In group B, the injection was effective in 17 eyes (60.7%), partially effective in 6 eyes (21.4%), and ineffective in 5 eyes (17.9%). The mean number of injections was significantly lower in group A than in group B: 1.61 ± 0.50 versus 2.36 ± 1.16. This study results suggest that betamethasone is more effective with a smaller number of injections than triamcinolone in the management of thyroid eye disease-related upper eyelid retraction.

Aflibercept in a real-world setting: the AURIGA study : 24-month results of the German cohort of treatment-naïve patients with macular edema following retinal vein occlusion receiving intravitreal aflibercept

AURIGA is the largest prospective real-world study to evaluate intravitreal aflibercept 2 mg (IVT-AFL) treatment of macular edema (ME) secondary to retinal vein occlusion (RVO) and diabetic macular edema. Here we present the 24-month data from the German cohort of treatment-naïve patients with ME due to RVO. Treatment-naïve patients with ME secondary to RVO were treated with IVT-AFL 2 mg in the routine clinical practice. The primary endpoint was mean change in visual acuity (VA, early treatment diabetic retinopathy, ETDRS, letters) at month12 compared to baseline. Analyses were descriptive. Analysis included 130 patients with RVO (n = 61, 46.9% with central RVO, n = 69, 53.1% with branch RVO). The mean (±SD) time the RVO patients remained in the study was 18.4 ± 7.4months. The mean VA gain (95% confidence interval) in the overall cohort was +10.9 (7.5-14.2) letters at month12 and +9.7 (6.1-13.3) at month24 (baseline VA 56.5 ± 18.9 letters). At 24months, 67% of RVO patients gained ≥5letters and 40% gained ≥15letters. The mean number of injections was 4.4 ± 1.3 up to month6, 6.2 ± 2.7 up to month12 and8.2 ± 4.5 up to month24. The mean central retinal thickness (CRT) reduction was -206µm (-252 to -160µm) at 12months and -219µm (-263 to -175µm) at 24months (baseline CRT 507 ± 177 µm). The safety profile was consistent with that of previous studies. In the German AURIGA cohort of treatment-naïve patients with ME secondary to RVO, IVT-AFL 2 mg treatment in clinical practice resulted in rapid and clinically relevant VA gains and areduction in CRT. These results were largely maintained over 24months despite the low injection frequency from month6.

Real-World 1-Year Outcomes of Treatment-Intensive Neovascular Age-Related Macular Degeneration Switched to Faricimab

PurposeTo report one-year anatomical and functional real-world outcomes of treatment intensive neovascular age related macular degeneration (nAMD) patients switched to faricimab DesignRetrospective multi-centre cohort study SubjectsConsecutive nAMD patients on 4-weekly treatment interval with either ranibizumab or aflibercept 2mg in the last three visits within a treat and extend protocol (high treatment burden) prior to switch to faricimab at Moorfields Eye Hospital between 5/9/2022- 5/12/2022. MethodsTotal number of nAMD patients switched to faricimab were identified from electronic medical records and those who met criteria of high treatment burden were included. Data collected included pre and post-switch visual acuity (VA), treatment intervals, length of follow-up, baseline macular morphology, changes in central subfield thickness (CST), macular fluid status and adverse events. Main outcome measuresVA, CST, presence of intraretinal fluid (IRF), subretinal fluid (SRF) and injection intervals over one-year following switch to faricimab. ResultsA total of 130/ 286 (45.5%) eyes met inclusion criteria of being switched due to high treatment burden and 117 were included in analysis. Prior to switch to faricimab, these eyes received mean total number of injections of 33.4±19.6 over mean of 51.3±34.9 months. Mean number of injections in 12 months preceding switch was 10.1±1.6 and mean interval of the preceding three injections was 4.2±0.3 weeks. Mean VA, CST and percentage of patients with dry macula prior to switch were 66.0±11.9 ETDRS letters, 259.6±76.0μm and 18.3% respectively. Following switch, there was no statistical difference in mean VA after each visit and at 12 months. Mean CST statistically significantly reduced following the 3rd faricimab injection and at 12 months by 20.0μm (p=0.035) and 22.1μm (p=0.041) respectively. Mean treatment intervals increased to 6.9±2.3 weeks (p<0.005) at 12 months with 42.9% and 11.4% of patients being on ≥8 weekly and ≥12 weekly treatment intervals respectively. ConclusionAt 12 months, patients with nAMD with previous record of high treatment burden when switched to faricimab maintained visual acuities and improved anatomical outcomes on extended treatment intervals. Physician bias is inherent in these types of observational studies so a prospective randomised controlled trial is recommended to validate these findings.

Cataract Surgery in nAMD Patients Receiving Intravitreal Aflibercept Injections.

Background: To evaluate functional and anatomical outcomesof cataract surgery in neovascular age-related macular neovascularization (nAMD) eyes receiving anti-vascular endothelial growth factor (anti-VEGF) intravitreal injections in modified pro re nata (PRN) regimen. Materials and Methods: Sixty eyes of 60 nAMD patients, including 41 women (68.3%) and 19 men (31.7%) in an average age of 77.35 ± 6.41 years, under treatment with intravitreal aflibercept injections in modified PRN regimen with no signs of macular neovascularization (MNV) activity during two consecutive visits were included in this prospective, observational study. Best-corrected visual acuity (BCVA), central retinal thickness (CRT), as well as the number of anti-VEGF injections were monitored six months before and after phacoemulsification with intraocular lens (IOL) implantation. Further, the change of the abovementioned parameters was assessed during the six-month follow-up period for CRT and the number of injections, while the BCVA was monitored for 54 months. Results: BCVA measured on the first day after surgery (0.17 ± 0.19 logMAR) as well as in the six-month post-surgery (0.13 ± 0.16 logMAR) significantly improved compared to preop values (0.42 ± 0.20 logMAR). BCVA remains stable during the observational period. We found that both differences were statistically significant (p < 0.01). The mean CRT and the mean number of injections did not differ between the six-month pre- and post-surgical periods. Conclusions: We showed the beneficial effect of phacoemulsification in nAMD patients treated with anti-VEGF agents on visual outcomes in the short and long term. Cataract surgery in nAMD eyes treated with anti-VEGF injections does not increase the frequency of anti-VEGF injections and does not cause deterioration of the macular status.

Comparing ranibizumab, dexamethasone implant, and combined therapy for macular edema secondary to branch retinal vein occlusion: a clinical trial.

Macular edema (ME) is a common complication following branch retinal vein occlusion (BRVO) and is also the main reason for visual impairment. This study aimed to compare the efficacy and safety of intravitreal ranibizumab (IVR) or dexamethasone implant (IDI) monotherapy, as well as the combination of IVR and IDI injections, in patients with ME secondary to branch retinal vein occlusion (BRVO). This multicenter, prospective, and comparative study included 292 patients with unilateral ME involvement (total of 292 eyes) secondary to BRVO. The patients were randomly assigned to three groups and followed up for 12months. Patients in group 1 (n = 96) were treated with 3-dose loading IVR injections followed by a pro re nata (PRN) regimen. Patients in group 2 (n = 98) received IVR combined with IDI injection, followed by IVR PRN regimen. Patients in group 3 (n = 98) were treated with IDI injection, followed by repeated IDI injection based on clinical necessity. Best corrected visual acuity (BCVA), central retinal thickness (CRT), complications, and frequency of injections were recorded and compared between the three groups. At baseline, the three groups did not differ in age, gender, duration of ME, BCVA, IOP, and CRT (P > 0.05). Mean number of total injections per eye within 12months were 7.1 ± 2.3 (range 4-9) in group 1, 3.7 ± 1.5 (range 2-6) in group 2, and 1.8 ± 0.4 (range 1-3) in group 3. There was a statistical difference in the number of injections between group 1 and group 2 (P = 0.037). Eyes in group 3 received fewer injections than those in group 2, but the difference was not statistically significant (P = 0.052). BCVA improvement and CRT reduction were achieved in all groups and there was no significant difference between the three groups at the end of the 12th month. However, IOP elevation and cataract progression were more frequent in group 3, especially in those patients who received repeated IDI injections. Three therapeutic regimens had comparable efficacy in treating ME secondary to BRVO. Combination therapy had an advantage in maintaining good effect with fewer re-injections and complications. The study complied with the principles of the Declaration of Helsinki and was approved by Xi'an Aier Ancient City Eye Hospital, Xi'an Aier Eye Hospital, and Xianyang Aier Eye Hospital ethics committees (2022SF-367).

Résultats anatomiques et fonctionnels du protocole thérapeutique « 3 + PRN » dans le traitement de l’œdème maculaire diabétique

Purpose: To evaluate the anatomical and functional results of the “3 + PRN” protocol in the treatment of diabetic macular edema (DME), determine the predictive factors for good final visual acuity, and compare it to other protocols.Materials and methods: We conducted a retrospective, descriptive, comparative, cross-sectional study of patients with DME, which we dubbed HTSM. All patients were treated with three monthly initial intravitreal injections (IVT) of 1.25 mg bevacizumab and followed according to the pro re nata (PRN) protocol for a period of 3 years. The protocol was based on a monthly monitoring schedule for the first 3 months, then increasingly spaced out over time. “On-demand” treatment was indicated with resumption of bevacizumab IVT in the event of worsening of DME.Results: A total of 52 patients were included. The mean age was 65 years. Type 2 was the most frequently observed type of diabetes. The mean duration of the PRN protocol was 6 months, and the mean number of injections was 6. The mean visual acuity (VA), initially 1/10, improved to 3/10 by the conclusion of the 3+PRN protocol, with an improvement of more than 5 letters in 77.6% of cases. The mean initial central macular thickness (CMT) was 451.5 µm. The final mean EMC decreased to 298.5 µm, which corresponds to a reduction of 153 µm compared to the initial value. The mean subfoveal choroidal thickness, initially 304.2 µm, decreased to a mean of 284.5 µm at completion. Comparative analysis of the results before and after the PRN protocol confirmed the existence of a statistically significant correlation between VA and CMT (p<0.05). No correlation was observed between age and visual acuity or between initial and final VA. The analysis of the various tomographic parameters and VA revealed a significantly better visual improvement in the group in whom the external limiting membrane (MLE) and ellipsoid zone (ZE) were intact (p = 0.04), as well as in the group in whom serous retinal detachment (SRD) was absent (p<0.001). Posterior vitreous detachment (PVD) was the most frequently observed vitreomacular anomaly. The final VA was similar in the groups with and without PVD (p = 0.04).Conclusion: The 3+PRN protocol is effective both functionally and tomographically in the treatment of DME. Various tomographic parameters might influence therapeutic efficacy. However, further in-depth studies are needed to better investigate these parameters.

Chorioretinal Atrophic Lesions Evolution in Patients with Quiescent Myopic Choroidal Neovascularization Followed for More Than 10 Years.

To evaluate the progression of chorioretinal atrophic areas associated with myopic choroidal neovascularization (CNV) in high myopic patients followed by a minimum period of 10 years. Patients with myopic CNV lesions that achieved clinical and structural remissions over 10 years of follow-up were included. Medical records were reviewed for CNV characterization and treatment, best-corrected visual acuity at baseline (BCVA0), immediately after the last treatment (BCVA1) and at the latest visit (BCVA2). Fundus autofluorescence (FAF) was used to quantify the amount of atrophic area increase per year associated with the treated myopic CNV lesion. The first FAF performed after treatment suspension (FAF1) was compared with the most recent exam (FAF2). Thirty-six eyes from 36 patients were included. Mean total follow-up was 12.38 ± 2.68 years. Mean number of intravitreal injections (IVI) was 12.50 ± 12.40 and 25% of the eyes had previous treatment with photodynamic therapy (PDT). Mean improvement between BCVA0 and BCVA1 was 5.58 ± 15.98 letters (p < 0.001). However, a drop of 8.03 ± 12.25 letters was noticed between BCVA1 and BCVA2. FAF1 was 6.34 ± 4.92mm2 and increased to 9.88 ± 7.56mm2 (3.54 ± 3.79mm2 variation p < 0.001). The mean growth rate of the atrophic area was 0.89 ± 0.84mm2 per year. BCVA2 negatively correlated with FAF2 (k = -0.498, p = 0.002) being worse in patients with higher atrophic area growth rate (k = -0.341, p = 0.042). Eyes treated with PDT needed less IVI (5.89 ± 5.21 vs 14.70 ± 13.36, p = 0.008) but had larger FAF1 (9.80 ± 5.33 vs 5.19 ± 4.27, p = 0.013) and FAF2 (16.05 ± 7.10 vs 7.83 ± 6.63, p = 0.003). Hypothyroidism was associated with higher atrophy growth rate (1.55 ± 1.15 vs 0.73 ± 0.67, p = 0.016). This research demonstrates the importance of chorioretinal atrophy progression after myopic CNV lesions regression and its impact on visual prognosis, reporting a mean yearly growth of 0.89 mm2 in atrophic areas. Previous treatment with PDT and hypothyroidism were identified as risk factors associated with larger atrophic areas and worse visual outcomes.