Change In Central Retinal Thickness Research Articles

The Reinforced Treat-and-Extend Protocol for Exudative Age-Related Macular Degeneration: Retrospective Assessment of 24-Month Real-World Outcomes in France.

The aim of this work is to evaluate the real-world outcomes of the reinforced treat-and-extend (RTE) protocol for the treatment of exudative age-related macular degeneration with intravitreal injections of aflibercept or ranibizumab (anti-vascular endothelial growth factor therapies). This was a retrospective review of patients from two tertiary ophthalmology centers in France initiating the RTE protocol between February 2018 and June 2021. The primary outcome was change in best-corrected visual acuity (BCVA) after 24months. Secondary outcomes were change in central retinal thickness (CRT), recurrence, and management-related factors (injection interval, number of injections/consultations). Outcomes were additionally evaluated after protocol changes (strict versus modified RTE protocol groups). Sixty-eight patients (72 eyes) were included (68% females; mean age 82.2 ± 7.8years). After 24months, mean BCVA significantly improved (65.22 ± 14 vs. 71.96 ± 13 Early Treatment Diabetic Retinopathy Study letters; p < 0.001) and CRT significantly decreased (388.6 ± 104 vs. 278.8 ± 51μM; p < 0.001) with 21% of eyes showing signs of exudation. Over the 24months, a mean total of 14.9 ± 4.0 injections and 8.6 ± 1.4 consultations were performed. Mean 24-month injection interval was 7.9 ± 2.3weeks. Initial and 24-month ophthalmic outcomes for eyes in the strict (47%) versus modified (53%) groups were not significantly different, but mean time interval to first recurrence of disease activity was significantly shorter for the modified group (7.3 ± 2.4 vs. 9.9 ± 2.5weeks; p < 0.001). Patients in the strict RTE group received significantly less injections (13.9 ± 3.6 vs. 16.5 ± 3.9; p = 0.006) and mean 24-month injection interval was significantly longer (9.5 ± 2.7 vs. 6.5 ± 2.1weeks; p < 0.001). Consultation number was similar (8.5 ± 1.9 vs. 8.8 ± 1.6; p = 0.93). Treatment with aflibercept versus ranibizumab did not influence ophthalmic or management outcomes. The RTE protocol, even when modified, reduced consultations but improved ophthalmic outcomes. The RTE protocol could reduce hospital visits and overall burden while also encouraging better patient compliance. Video Abstract available for this article. Vincent Soler and François-Philippe Roubelat summarize the Reinforced Treat-and-Extend Protocol and main results (MP4 225022 KB).

Real-World Experience with Brolucizumab Compared to Aflibercept in Treatment-Naïve and Therapy-Refractory Patients with Diabetic Macular Edema.

Background: To report on the outcome of intravitreal brolucizumab compared to aflibercept in patients with diabetic macular edema (DME). Methods: Prospective, observational, study in 35 eyes of 24 patients with a loading dose of five injections of 6 mg brolucizumab every 6 weeks (q6w, treatment-naïve eyes) or a minimum of two injections of brolucizumab q6w after the switch (recalcitrant DME eyes), followed by a treat and extend (T&E) regimen. The results were compared with 40 eyes of 31 DME patients who were treated with aflibercept. The data were obtained from the Berlin Macula Registry. The primary outcome measure was the change in best-corrected visual acuity (BCVA) at week 36. Secondary outcome measures were the change in central retinal thickness (CRT) and the treatment intervals until week 36. Results: BCVA increased significantly in treatment-naïve DME eyes treated with either brolucizumab (+0.12 logMAR, +6.4 letters, p = 0.03) or aflibercept (+0.19 logMAR, +9.5 letters, p = 0.001). In recalcitrant DME eyes, BCVA also increased significantly after switching to brolucizumab (+0.1 logMAR, +5 letters, p = 0.006) or aflibercept (+0.11 logMAR, +5.5 letters, p = 0.02). All treatment-naïve and recalcitrant DME eyes had a significant decrease in CRT after treatment with brolucizumab (p = 0.001 and p < 0.001) or aflibercept (p = 0.0002 and p = 0.03). At week 36, the mean treatment interval for brolucizumab was 11.3 weeks, while for aflibercept, it was 6.5 weeks for treatment-naïve eyes and 9.3 weeks vs. 5.3 weeks for pretreated eyes. Conclusions: In routine clinical practice, patients with treatment-naïve and recalcitrant DME showed a favorable response to brolucizumab and aflibercept therapy, with a reduced injection frequency after brolucizumab treatment.

Safety and Efficacy of Photodynamic Therapy with Chlorin E6 in Chronic Central Serous Chorioretinopathy.

To evaluate the efficacy and safety of photodynamic therapy (PDT) with chlorin E6 in chronic central serous chorioretinopathy (CSCR). This single-center, retrospective cohort study. All patients received standard PDT with 6 mg of chlorin E6 (Fotoran E6) for each m2 of body surface area with 50 J/cm2 fluence and a treatment time of 83 seconds. The changes in central retinal thickness (CRT), subfoveal choroidal thickness (SCT), and best-corrected visual acuity (BCVA) were evaluated at the end of the follow-up. Main outcome measure was the presence of subretinal fluid (SRF) at three months after PDT. Thirty-nine eyes (32 males and 7 females, 43.7 ± 10.0 years) were included. In total, 50 PDT sessions were performed. At three months of follow-up, 31 out of 39 (79.5%) study eyes showed complete resolution of SRF. Mean follow-up period after PDT was 15.3 ± 7.8 months. At the end of follow-up, a complete resolution of SRF was observed in 32 out of 39 (82.7%) eyes. Mean change in CRT, SCT, and BCVA at the end of the follow-up was -139.7 ± 136.4 µm, -66.8 ± 36.2 µm, and -0.05 ± 0.08 LogMAR, respectively (p < 0.001). Neither systemic nor ocular adverse events were observed, nor were local reactions seen. Standard PDT with chlorin E6 is an effective and safe option in the management of chronic CSCR and may be considered as an alternative to the standard PDT with Visudyne.

Short-term effect of intravitreal dexamethasone implant in refractory diabetic macular edema

PurposeTo evaluate the short-term effects (hours-days) of intravitreal dexamethasone implant (IDI) in eyes with diabetic macular edema (DME) refractory to anti-vascular endothelial growth factor (VEGF) injections.MethodsThis was a prospective, single-arm, interventional clinical series. Eyes with DME and 3–9 injections of ranibizumab without a good response were included. Patients underwent a single IDI. Best-corrected visual acuity (BCVA) measurement, complete ophthalmic evaluation, and spectral-domain optical coherence tomography (SD-OCT) were performed at baseline, 2 h, 3 h, 24 h, 7 days, and 1 month. The main outcomes were change in central retinal thickness (CRT) on SD-OCT and BCVA.ResultsFifteen eyes of 15 patients were included. Mean CRT decreased after treatment from 515.87 µm ± 220.00 µm at baseline to 489.60 µm ± 176.53 µm after 2 h (p = 0.126), and 450.13 µm ± 163.43 at 24 h (p = 0.006). Change in BCVA was from 0.85 ± 0.44 logMAR baseline to 0.58 ± 0.37 log MAR at 1 month (p = 0.003).ConclusionsEyes treated with IDI showed significant decrease in CRT detectable 1 day after injection. In some patients, the effect could be observed 3 h post-implantation.Trial registrationClinicaltrials.gov NCT05736081. Registered 20 February 2023, Retrospectively registered.

Interleukin-8 Promoter Polymorphism -251 A/T and Treatment Response in Neovascular Age-related Macular Degeneration.

Interleukin-8 (IL-8) is a potent pro-angiogenic and pro-inflammatory chemokine, suggested to hold a role in neovascular age-related macular degeneration (nAMD). Our aim is to study the association of the single-nucleotide polymorphism -251 A/T (rs4073) in the IL-8 promoter region with the treatment response to intravitreal anti-vascular endothelial growth factor (VEGF) injections in nAMD. This is a prospective study of treatment-naïve patients with nAMD. Treatment response after a loading dose of three intravitreal anti-VEGF injections was defined as functional response based on change in visual acuity, and morphological response based on change in central retinal thickness (CRT) and intraretinal fluid on optical coherence tomography. Morphological response was categorized in good, partial, and poor responders. Blood DNA was analyzed for -251 A/T genotype. The IL-8 promoter polymorphism -251 A/T was not significantly associated to functional treatment response (P=0.09). No significant association was found between genotype and morphological treatment response (P=0.799). Older age was significantly associated to good morphological responders compared to partial and poor responders (P=0.014). The IL-8 polymorphism -251 A/T is not associated to morphological nor functional treatment response to intravitreal anti-VEGF injections in patients with nAMD.

OCT Biomarkers Predicting Recurrence of Macular Edema Secondary to Branch Retinal Vein Occlusion

Purpose: We evaluated factors predicting the recurrence of macular edema in patients with branch retinal vein occlusion using optical coherence tomography (OCT).Methods: This study enrolled 55 patients diagnosed with branch retinal vein occlusion who presented to the outpatient clinic between March 2022 and March 2023. A retrospective analysis categorized patients into non-recurrence and recurrence groups. Data on visual acuity, spherical equivalent, intraocular pressure, number of injections, and follow-up duration were collected from medical records. OCT images were obtained before and 6 months after intravitreal injection to measure and analyze central retinal thickness, subfoveal choroidal thickness, and disorganization of retinal inner layers.Results: No statistically significant difference was observed in the central retinal thickness change before and after treatment between the groups. Although no significant differences were observed in visual acuity between the two groups before treatment, significant improvement in visual acuity was observed in the non-recurrence group after 6 months of treatment. The non-recurrence group was younger compared to the recurrence group; moreover, the intraocular pressure in non-recurrence patients decreased significantly during the 6-month treatment period. In addition, a decrease in subfoveal choroidal thickness before and after treatment, the difference in subfoveal choroidal thickness between the affected eye and the fellow eye before treatment, and the reduction in disorganization of retinal inner layers before and after treatment were associated with a favorable prognosis without recurrence.Conclusions: Changes in subfoveal choroidal thickness before and after treatment, variations in subfoveal choroidal thickness between the affected and fellow eyes before treatment, and the degree of disorganization of retinal inner layers exhibited significant associations with the recurrence of macular edema. This is significant because it allows for predictions based on baseline OCT images.

Outcomes of bimanual vitreoretinal surgery in the treatment of diabetic retinopathy complications

This study evaluates the long-term results of vitreorentinal surgery using the bimanual technique in DR with different stages of fibrovascular proliferation. The study included 135 patients (135 eyes) who were divided into groups depending on the predominant type of proliferation - vascular or fibrous. Patients underwent vitrectomy with membranectomy using the bimanual technique, with peripheral panretinal endolaser coagulation of the retina and tamponade of the vitreous cavity with balanced salt solution. The postoperative observation period lasted up to 12 months. Both groups showed statistically significant improvement in visual function and anatomical changes in central retinal thickness. A statistically significant improvement in best corrected visual acuity (BCVA) was found in patients with initially predominantly vascular proliferation. Correlation analysis showed that initially higher BCVA tends to persist in the postoperative period. A negative correlation was found between the final BCVA and the presence of type 2 diabetes mellitus, fibrous stage of proliferation, high central retinal thickness, and the presence of diabetic macular edema (DME) - both initially and after treatment. The frequency of complications in the groups was comparable, except for postoperative DME, which was more often detected in patients with fibrous proliferation. The bimanual technique of vitreorentinal surgery for complications of DR allows achieving high anatomical and functional results. Higher BCVA is noted in patients with the vascular stage of proliferation and initially high BCVA. The obtained data allow us to form a hypothesis about the possibility of earlier surgery in patients with high BCVA, but require further investigation.

Real-World Management of Macular Edema Secondary to Retinal Vein Occlusion with Intravitreal Aflibercept: 24-month Results from the AURIGA Observational Study.

AURIGA is the largest real-world study to date to evaluate intravitreal aflibercept (IVT-AFL) treatment of diabetic macular edema or macular edema secondary to retinal vein occlusion (RVO) in routine clinical practice. Here, we report the 24-month outcomes in the RVO cohort from France, Germany, Italy, and Taiwan. AURIGA (NCT03161912) was a prospective observational study. Eligible patients with RVO were enrolled for whom the decision to treat with IVT-AFL had already been made by the attending physician. Patients were treated with IVT-AFL for up to 24 months at physician discretion according to local practice. The primary endpoint was mean change in visual acuity (VA; Early Treatment Diabetic Retinopathy Study [ETDRS] letters) from baseline to month (M) 12. All statistical analyses were descriptive. In 554 treatment-naïve and 65 previously treated patients with RVO, the respective mean (95% confidence interval) change in VA from baseline was + 12.5 (10.8, 14.3) and + 7.9 (3.3, 12.6) letters by M12 and + 11.4 (9.4, 13.3) and + 4.4 (- 0.6, 9.5) letters by M24 (baseline mean ± standard deviation: 51.0 ± 21.9 and 51.9 ± 20.4 letters); 44.0% of treatment-naïve and 27.9% of previously treated patients reported ≥ 15-letter gains by M24. By M24, the mean change in central retinal thickness from baseline was - 247 (- 267, - 227) µm in treatment-naïve patients and - 147 (- 192, - 102) µm in previously treated patients. From baseline to M6, M12, and M24, treatment-naïve patients received a total of 4.0 ± 1.3, 5.5 ± 2.5, and 6.9 ± 4.2 injections, respectively, and previously treated patients received 3.8 ± 1.5, 5.0 ± 2.2, and 6.3 ± 3.7 injections, respectively. The safety profile of IVT-AFL was consistent with that of previous studies. In AURIGA, patients with RVO experienced clinically relevant functional and anatomic improvements following IVT-AFL treatment in routine clinical practice. These improvements were largely maintained in treatment-naïve patients over the 24-month study despite the decreasing treatment frequency, suggesting long-term durability of IVT-AFL treatment outcomes.Infographic available for this article. ClinicalTrials.gov Identifier: NCT03161912 (May 19, 2017). INFOGRAPHIC.

The effects of non-prostaglandin hypotensive drops with preservative on central retinal thickness after phacoemulsification

BACKGROUND: Primary open angle glaucoma is often associated with cataract. The correlation between the use hypotensive drops, in particular non-prostaglandin hypotensive drops with preservative, and the change in central retinal thickness after phacoemulsification with intraocular lens implantation continues to be relevant.&#x0D; AIM: To evaluate central retinal thickness and pseudophakic cystoid macular edema incidence after phacoemulsification with intraocular lens implantation in patients with primary open-angle glaucoma using non-prostaglandin hypotensive drops with preservatives.&#x0D; MATERIALS AND METHODS: 94 patients (108 eyes) with cataract were enrolled in the study, divided into 3 groups: the first group 21 patients (27 eyes), and the second group 21 patients (23 eyes) with primary open-angle glaucoma using non-prostaglandin hypotensive drops with preservative; the third (control) group included 52 patients (58 eyes) without ocular comorbidities. All patients underwent uncomplicated phacoemulsification with intraocular lens implantation. In the post-op period, patients of the first group received topical antibiotics and steroids, patients of the second and the third groups received the same treatment and non-steroidal anti-inflammatory drops as well. Central retinal thickness was measured using optical coherence tomography before surgery, 2 weeks, 2 and 6 months after surgery.&#x0D; RESULTS: The central retinal thickness increase in comparison with baseline values was more significant in the first group than in the second and the third groups, and the time of recovery to baseline values during 6 months after surgery was longer. Pseudophakic cystoid macular edema was not identified in any group.&#x0D; CONCLUSIONS: The use non-prostaglandin drops with preservative in patients with primary open-angle glaucoma does not affect pseudophakic cystoid macular edema development after uncomplicated phacoemulsification. Instillations of non-steroidal anti-inflammatory drops in the post-op period reduce the time of central retinal thickness recovery to baseline value.

Outcomes and Adverse Effects of Voretigene Neparvovec Treatment for Biallelic RPE65-Mediated Inherited Retinal Dystrophies in a Cohort of Patients from a Single Center.

Our study evaluated the morphological and functional outcomes, and the side effects, of voretigene neparvovec (VN) gene therapy for RPE65-mediated inherited retinal dystrophies (IRDs) in 12 eyes (six patients) at the Oxford Eye Hospital with a mean follow-up duration of 8.2 (range 1-12) months. All patients reported a subjective vision improvement 1 month after gene therapy. Best-corrected visual acuity (BCVA) remained stable (baseline: 1.28 (±0.71) vs. last follow-up: 1.46 (±0.60); p = 0.25). Average white Full-Field Stimulus Testing (FST) showed a trend towards improvement (baseline: -4.41 (±10.62) dB vs. last follow-up: -11.98 (±13.83) dB; p = 0.18). No changes in central retinal thickness or macular volume were observed. The side effects included mild intraocular inflammation (two eyes) and cataracts (four eyes). Retinal atrophy occurred in 10 eyes (eight mild, two severe) but did not impact FST measurements during the follow-up period. Increased intraocular pressure (IOP) was noted in three patients (six eyes); four eyes (two patients) required glaucoma surgery. The overall safety and effectiveness of VN treatment in our cohort align with previous VN clinical trials, except for the higher occurrence of retinal atrophy and increased IOP in our cohort. This suggests that raised IOP and retinal atrophy may be more common than previously reported.

An Analysis of Optical Coherence Tomography Angiography (OCT-A) Perfusion Density Maps in Patients Treated for Retinal Vein Occlusion with Intravitreal Aflibercept.

The primary goal of this study was to evaluate the reduction in non-perfusion area and improvement in blood flow as well as the reduction in retinal edema on optical coherence tomography angiography (OCT-A) in patients with retinal vein occlusion treated with 2 mg intravitreal injections of aflibercept. Fifty eyes of nine patients with central retinal vein occlusion (CRVO) and sixteen patients with branch retinal vein occlusion (BRVO), aged 50 to 75 years, were collectively analyzed as retinal vein occlusion (RVO). The following parameters were analyzed: superficial vessel density (VDSF), deep vessel density (VDD), flow area in the outer retina (FAOR), choriocapillaris flow area (FACC), non-flow area (NFA) and the foveal avascular zone (FAZ). OCT-A revealed a reduction in macular edema. The most significant change in central retinal thickness (CRT) was observed between measurement timepoint "5" and the baseline (46%). The non-flow area was also reduced. Following a significant decrease in superficial vessel density 30 days after the first dose of aflibercept, a non-significant increase was noted at the subsequent timepoints. An increase was also found in deep vessel density and choriocapillaris flow area. Improvements in the above OCT-A parameters resulted in increased retinal blood flow and improved visual acuity. Patients with retinal vein occlusion treated with 2 mg aflibercept exhibited reduced macular edema and FAZ, increased vessel density, improved blood flow, and better visual acuity.

Retinal and Choroidal Changes Following Implantable Collamer Lens V4c Implantation in High Myopia Patients-A 1-Year Follow-Up Study.

This prospective study aimed to evaluate the impact of Visian Implantable Collamer Lens (ICL) V4c implantation on retinal and choroidal morphology in patients with high myopia. A total of 97 eyes from 52 high myopic patients who underwent ICL V4c implantation were followed up for 12 months. Preoperative and postoperative evaluations included comprehensive ophthalmic assessments and enhanced depth imaging optical coherence tomography (EDI-OCT) to analyze changes in central retinal thickness (CRT), retinal volume (CRV), choroidal thickness (ChT), total choroidal area (TCA), luminal area (LA), and choroidal vascular index (CVI). Repeated measures mixed-effects models were used for comparing pre- and postoperative measurement variables and exploring relationships among age, axial length (AL), spherical equivalent refraction (SER), and postoperative retinal and choroidal changes, with statistical significance set at p < 0.05. Follow-up assessments were conducted at various time points, with participation rates ranging from 21% to 98%. Baseline characteristics showed a median age of 26.7 years, -10.14 diopters of SER, and an AL of 27.44 mm. Throughout the 12-month follow-up, CRT and 3.0 mm CRV consistently increased compared to the baseline, with statistically significant rises observed at postoperative day 1, week 1, and month 12. Most ChT measurements, including subfoveal ChT, declined over the 12 months, except at postoperative 6 months. Horizontal and vertical TCA and LA values significantly increased throughout the follow-up, except for month 6. After surgery, both horizontal and vertical CVI parameters exhibited an increase compared to the baseline, with some changes reaching statistical significance. Correlation analysis performed by repeated measures mixed-effects models showed that no relationship was found between age, AL, and SER and changes in postoperative retinal parameters and CVI parameters. However, postoperative changes in ChT and choroidal area parameters showed a negative correlation with AL and a positive correlation with SER. Our research demonstrated that ICL V4c implantation resulted in noteworthy alterations in retinal and choroidal morphology over a 1-year follow-up period. Moreover, in patients with high myopia, individuals with longer AL and higher degrees of myopia exhibited more pronounced postoperative changes in the choroid and retina. Further studies with extended follow-up durations are necessary to comprehensively understand the long-term effects of ICL implantation on retinal and choroidal morphology and function.

Impact of Phacoemulsification Parameters on Central Retinal Thickness Change Following Cataract Surgery.

Cataract surgery can lead to inflammatory processes in the retina due to its invasive nature, resulting in prolonged recovery times and reduced functional outcomes. The aim of the current study is to explore the impact that phacoemulsification parameters have on macular thickness following surgery. This prospective single-center study enrolled 46 healthy patients (46 eyes) who underwent uneventful cataract surgery. Retinal thickness was assessed using optical coherence tomography (OCT) preoperatively, as well as 1, 4, and 12 weeks after surgery. The macula was divided into a central (CMT), inner (IMT), and outer ring (OMT). Cataract density was automatically determined using an anterior segment OCT and a custom MATLAB script. Corrected distance visual acuity (CDVA), intraocular pressure (IOP) as well as cumulative dissipated energy (CDE), ultrasound time (UT), and fluids used during phacoemulsification were recorded. Retinal thickness and volume increased significantly following cataract surgery, reaching its maximum 4 weeks post-operatively. Statistically significant correlations were found between the CDE and IMT, OMT and retinal volume change (rIMT = 0.356, rOMT = 0.298, rvolume = 0.357 with p < 0.05) as well as between the ultrasound time and IMT, OMT, and retinal volume change (rIMT = 0.369, rOMT = 0.293 and rvolume = 0.409 with p < 0.05). Changes in CMT did not correlate with any surgical metrics. Additionally, no correlation was found to the amount of fluid used, whether CDVA or IOP. However, a link between nuclear cataract density and changes in OMT (r = 0.310, p < 0.05) was established. How ultrasound energy impacts the choroidea, and to what extent retinal metabolism changes after surgery, needs to be explored in future studies.

Effect of High-Dose Intravitreal Aflibercept, 8 mg, in Patients With Neovascular Age-Related Macular Degeneration

Aflibercept, 8 mg, may have greater therapeutic benefits compared with aflibercept, 2 mg, in patients with neovascular age-related macular degeneration (nAMD), including potentially improved outcomes and decreased treatment burden. To assess safety and efficacy of aflibercept, 8 mg, in patients with nAMD. The CANDELA trial was a phase 2, randomized, single-masked, open-label, 44-week clinical trial conducted in the US. Treatment-naive patients with active subfoveal choroidal neovascularization secondary to nAMD and a best-corrected visual acuity score of 78 to 24 letters (approximately 20/32 to 20/320) in the study eye were enrolled between November 2019 and November 2021. Eligible participants were randomized 1:1 to receive 3 monthly doses of 8 mg (70 μL) or 2 mg (50 μL) of aflibercept followed by doses at weeks 20 and 32. Coprimary end points were the proportion of eyes without fluid (absence of intraretinal and subretinal fluid) in the central subfield at week 16 and safety. All 106 eligible eyes were randomized to receive aflibercept, 8 mg (n = 53), or aflibercept, 2 mg (n = 53). Overall, 66 participants (62.3%) were female. The proportion of eyes without fluid in the central subfield with 8-mg vs 2-mg aflibercept was 50.9% (n = 27) vs 34.0% (n = 18) (difference, 17.0 [95% CI, -1.6 to 35.5] percentage points; P = .08) at week 16 and 39.6% (n = 21) vs 28.3% (n = 15) (difference, 11.3 [95% CI, -6.6 to 29.2] percentage points; nominal P = .22) at week 44. At week 44, mean (SE) change in central retinal thickness was -159.4 (16.4) vs -137.2 (22.8) μm with 8 mg vs 2 mg of aflibercept, respectively (least squares mean difference, -9.5 [95% CI, -51.4 to 32.4]; nominal P = .65) and mean (SE) change in best-corrected visual acuity score was +7.9 (1.5) vs +5.1 (1.5) letters (least squares mean difference, +2.8 [95% CI, -1.4 to +7.0]; nominal P = .20). No differences in safety profiles between the groups were observed. Although aflibercept, 8 mg, did not achieve the primary efficacy end point at week 16 at the 2-sided significance level of 5%, the observed trends in anatomic and visual improvements over 44 weeks with aflibercept, 8 mg, indicate potential additional therapeutic benefit over aflibercept, 2 mg. No new safety signals were observed over 44 weeks. These findings support further evaluation of aflibercept, 8 mg, in pivotal trials of exudative retinal diseases including nAMD and diabetic macular edema. ClinicalTrials.gov Identifier: NCT04126317.

Efficacy of as-needed intravitreal injection compared to 3-monthly loading of anti-vascular endothelial growth factor agents for branch retinal vein occlusion

We investigated the efficacy of intravitreal injection of anti-vascular endothelial growth factor (VEGF) agents in branch retinal vein occlusion (BRVO). Databases, including PubMed, EMBASE, and the Cochrane Library, were searched on November 11, 2022. Studies comparing the pro-re-nata (PRN) regimen after the first treatment (PRN group) to three consecutive monthly injection regimens followed by the PRN regimen (3 + PRN group) were investigated. The primary outcomes were the change in best-corrected visual acuity (BCVA) and the change in central retinal thickness (CRT), with the secondary outcome being the injection frequency. Among 195 reports on anti-VEGF treatment, six comparative studies were included in this meta-analysis. The two groups had no statistically significant differences in terms of BCVA or CRT. However, the total number of injections during follow-up was significantly lower in the PRN group than in the 3 + PRN group (95% CI − 2.09 to − 0.83). The as-needed injection regimen is as effective as 3-monthly loading in terms of anatomical and functional improvement for BRVO, along with a lower treatment burden for patients and physicians.

Diurnal functional and anatomical changes in X-linked retinoschisis

BackgroundTo investigate the changes in macular cystic schisis (MCS) and sensitivity during the day in X-linked retinoschisis (XLRS) patients.MethodsTreatment-naïve patients with genetically verified XLRS underwent best-correlated visual acuity (BCVA) testing with ETDRS charts, spectral domain optical coherence tomography, and microperimetry (MP) twice a day, at 9 a.m. and 4 p.m., to measure changes in central retinal thickness (CRT), macular volume (MV), average threshold (AT), and fixation stability parameters (P1 and P2).ResultsAt baseline, the BCVA of the 14 eyes of 8 patients amounted 0.73 (± 0.23) LogMAR. Between timepoints, the BCVA increased in 3.21 letters (p = .021), the AV improved in 1.84 dB (p = .03, 9.73%), the CRT decreased in 24.43 µm (p = .007, − 4.05%), and the MV dropped in 0.27 µm3 (p = .016, − 2.68%). P1 and P2 did not variate. The collapse of the MCS led to the reduction of macula thickness. CRT at baseline correlated with the decrease of CRT (Spearman’s ρ: − 0.83 [p = .001]). Age and change of BCVA, CRT, and AV did not correlate among one another. Eyes with disrupted ellipsoid zone showed a more prominent change in CRT (p = .050). Photoreceptor outer segment length and integrity of the external limiting membrane and cone outer segment tips were not associated with BCVA, AT, or CRT variation.ConclusionEyes of treatment-naïve XLRS patients show diurnal macular thickness and function changes. Eyes with pronounced macular thickness show a greater reduction of the MCS. These results should be taken into consideration in upcoming clinical trials in XLRS.Trial registration numberInstitutional Review Board of the Hamburg Medical Chamber (Ethik-Kommission der Ärztekammer Hamburg): 2020–10,328.

CO35 Real-World Effectiveness of Intravitreal Ranibizumab and Aflibercept for Eyes with Central Retinal Vein Occlusion: A Multi-Institutional Cohort Study in Taiwan

Intravitreal ranibizumab and aflibercept is the mainstream therapy for central retinal vein occlusion (CRVO), a common cause of vision loss in adults. However, the long-term effectiveness of changes in central retinal thickness (CRT) and visual acuity (VA) post ranibizumab and aflibercept therapy remains unclear in Taiwan.

Real-world effectiveness of intravitreal dexamethasone implants - Comparison between eyes eligible and ineligible for clinical trials and their associated outcomes

BackgroundConcerns about the generalizability of pivotal randomized controlled trials (pRCTs) findings have been raised. We aimed to compare intravitreal dexamethasone implants’ (IDIs) effectiveness for diabetic macular edema (DME) and central retinal vein occlusion (CRVO), between eyes eligible and ineligible for pRCTs. MethodsThis retrospective cohort study analyzed Taiwan's Chang Gung Research Database, including DME or CRVO eyes initiating IDIs during 2015–2020. We classified all treated eyes as eligible or ineligible for pRCTs following major selection criteria of the MEAD and GENEVA trials, and evaluated three-, six-, and twelve-month changes in central retinal thickness (CRT) and visual acuity (VA) after initiating IDIs. ResultsWe included 177 IDI-treated eyes (DME: 72.3%; CRVO: 27.7%), of which 39.8% and 55.1% were ineligible for DME and CRVO pRCTs, respectively. LogMAR-VA and CRT changes at different times were comparable in DME eyes eligible (LogMAR-VA difference: 0.11 to 0.16; CRT difference: −32.7 to −96.9 μm) and ineligible (LogMAR-VA difference: −0.01 to 0.15; CRT difference: −54.5 to −109.3 μm) for the MEAD trial. By contrast, CRVO eyes ineligible for the GENEVA trial had greater LogMAR-VA changes (0.37 ~ 0.50) than those eligible (0.05 ~ 0.13), with comparable CRT reductions (eligible eyes: −72.3 to −106.4 μm; ineligible eyes: −61.8 to −110.7 μm) (all p-values <0.05 of the mean differences between eligible and ineligible CRVO eyes for all follow-ups). ConclusionsIDIs had similar VA and CRT outcomes among DME eyes, regardless of pRCT-eligibility. However, among CRVO eyes, those ineligible for pRCTs showed greater deterioration in VA than those eligible.

Maximal Extension Interval and Visual Outcomes in a Treat-and-Extend Protocol: A Post Hoc Analysis of the CANTREAT Randomized Trial

Introduction: The Canadian Treat-and-Extend Analysis Trial with Ranibizumab (CANTREAT) was a 2-year, multicentred, randomized clinical trial to evaluate treat-and-extend (T&E) relative to monthly administration of ranibizumab in neovascular age-related macular degeneration (nAMD). This post hoc analysis of the CANTREAT trial explores the relationship between the maximal extension interval tolerated by patients receiving T&E ranibizumab and visual acuity outcomes. Methods: Treatment-naïve patients with nAMD were randomized to receive either a once-monthly dosing or T&E regimen of ranibizumab across 27 treatment centres in Canada and were followed for 24 months. For this post hoc analysis, patients in the T&E cohort were subdivided into the following groups based on maximum extension interval: 4 weeks, 6 weeks, 8 weeks, 10 weeks, and 12 weeks. The primary outcome was the change in ETDRS best-corrected visual acuity (BCVA) from baseline to month 24 while secondary outcomes included change in central retinal thickness (CRT). All results were reported using descriptive statistics. Results: A total of 285 participants undergoing T&E were enrolled in this post hoc analysis. At month 24, the change in BCVA from baseline was +8.5 ± 9.3, +7.7 ± 13.8, +4.4 ± 9.6, +4.4 ± 18.5, and +7.8 ± 14.8 letters in the 4-, 6-, 8-, 10-, and 12-week cohorts, respectively. The change in CRT at month 24 was −79.2 ± 95.0, −143.9 ± 128.9, −97.7 ± 101.1, −120.9 ± 105.3, and −133.2 ± 108.8 μm in the 4-, 6-, 8-, 10-, and 12-week cohorts, respectively. Conclusion: The capacity to extend does not necessarily associate with improved visual acuity outcomes, with the poorest change in BCVA seen in those extended 8–10 weeks. The highest change in BCVA and lowest decrease in CRT was in the group maximally extended for 4 weeks. There was a correlation between change in BCVA and change in CRT for other extension groups. Future studies should establish the predictive factors for successful extension in patients undergoing T&E in nAMD.

Spectrofluorimetric changes in the lens after intravitreal injections of brolucizumab

The study evaluates the changes in spectrofluorometric parameters of the lens after intravitreal injections of brolucizumab in eyes with native lens. The study included 13 people with neovascular age-related macular degeneration (AMD) who received IVI of brolucizumab. All patients were over 40 years old; changes in central retinal thickness in the macular area exceeded 300 μm according to optical coherence tomography. Spectrofluorimetric indicators of the lens were studied before and after injections of the drug in both eyes. The spectra were analyzed in the wavelength range 412-698 nm to record the changes in the content of non-tryptophan fluorophore molecules in the lens. Spectrofluorimetry revealed metabolic changes in the native lens after intravitreal injections of the drug brolucizumab. No such changes were observed in the lens of the eyes not injected with the drug (the «Control» group). The proposed investigation technique involves prospective assessment of the safety of various molecules injected intravitreally in terms of cataract development at various times after the injection. Spectrofluorimetry can be used for identifying initial metabolic changes in the lens. It is a promising method for assessing the molecules used in intravitreal injections in terms of their safety for the native lens, as well as for development of detailed instructions for clinically substantiated use of drugs with adverse effects in the form of cataract induction. According to spectrofluorimetry, IVI of the drug brolucizumab affects metabolic changes in the lens.