Mean Change In Visual Acuity Research Articles

Aflibercept in the clinical routine: the AURIGA study : The 24-month results of the German cohort of treatment-naïve patients with diabetic macular edema receiving intravitreal aflibercept

AURIGA is the largest prospective real-world study to evaluate intravitreal aflibercept (IVT-AFL) treatment of diabetic macular edema (DME) and macular edema secondary to retinal vein occlusion. This article presents 24-month data from the German cohort of treatment-naïve patients with DME. Treatment-naïve patients (≥ 18years) with DME were treated with IVT-AFL at the discretion of the physician in clinical practice. The primary endpoint was mean change in visual acuity (early treatment diabetic retinopathy, ETDRS, letters) at month12 compared to baseline. Statistical analyses were descriptive. The analysis included data from 150 DME patients (54.7% male). At months6, 12 and24, mean (95% confidence interval) visual acuity gains of4.6 (2.6; 6.5), 4.0 (2.1; 6.5) and 5.0 (3.0; 6.9) letters from baseline (mean ±SD: 65.0 ± 15.3 letters) and reductions in retinal thickness of 86µm (109; 64µm), 70µm (94; 43µm) and 75µm (103; 47µm) from baseline (mean ±SD: 391 ± 132 µm), respectively, were achieved. At month24, 54% of patients gained ≥ 5 letters and 22% ≥ 15 letters. Patients received amean number of 5.0 ± 1.6injections until month6, 7.1 ± 3.2 until month12 and9.0 ± 5.3 until month24, 68% of patients received ≥ 5injections until month6 and 56% ≥ 7injections within the first year. The safety profile was consistent with previous studies. In the German AURIGA cohort, treatment-naïve DME patients achieved aclinically relevant gain in visual acuity as well as reduction in central retinal thickness following IVT-AFL treatment in clinical practice. From month6 onwards, improvements were maintained despite alow injection frequency over 24months. In comparison with previous real-world studies, care of DME patients in clinical practice seems to have improved; however, there is still room for further improvement.

EFFICACY AND SAFETY OF THE PROPOSED BIOSIMILAR AFLIBERCEPT, SDZ-AFL, IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: 52-Week Results From the Phase 3 Mylight Study.

The Phase 3 Mylight study was designed to confirm clinical equivalence of proposed biosimilar aflibercept (SOK583A1; Sandoz [proposed biosimilar aflibercept, SDZ-AFL]) to its reference biologic (Eylea; Regeneron Pharmaceuticals, Inc; Bayer AG [reference aflibercept, Ref-AFL]). Mylight was a prospective, double-masked, 2-arm, parallel Phase 3 study. Participants with neovascular age-related macular degeneration were randomized 1:1 to receive eight injections of SDZ-AFL (n = 244) or Ref-AFL (n = 240) over 48 weeks. The primary endpoint was mean change in best-corrected visual acuity score from baseline to Week 8. Secondary endpoints included anatomical outcomes, best-corrected visual acuity at Weeks 24 and 52, safety, and pharmacokinetics. Similarity in mean change in best-corrected visual acuity score was established between SDZ-AFL (n = 235) and Ref-AFL (n = 226) at Week 8 (difference: -0.3 [90% CI, -1.5 to 1.0]) and Week 52. No clinically meaningful differences occurred between groups in anatomical outcomes. Safety profiles were similar, with comparable incidences of treatment-related adverse events (SDZ-AFL: 2.5%; Ref-AFL: 2.9%). The incidence of anti-drug antibodies was similar between groups. Systemic free aflibercept concentrations 24 hours postdose were low and comparable between SDZ-AFL and Ref-AFL. Proposed biosimilar aflibercept matched reference aflibercept in efficacy, safety, and pharmacokinetics in participants with neovascular age-related macular degeneration. Therefore, this Phase 3 study confirmed biosimilarity of SDZ-AFL to Ref-AFL.

PROSPECTIVE TRIAL OF HOME OPTICAL COHERENCE TOMOGRAPHY-GUIDED MANAGEMENT OF TREATMENT EXPERIENCED NEOVASCULAR AGE-RELATED MACULAR DEGENERATION PATIENTS.

To evaluate the impact of home optical coherence tomography (OCT)-guided patient management on treatment burden and visual outcomes. An interventional trial was conducted to compare frequency of treatment and visual acuity for the neovascular age-related macular degeneration patients before and during use of home optical coherence tomography over a period of 6 months. Patient adherence to regular scanning was measured by the number of scans performed per week. The characteristics of episodes of fluid recurrence and classification of typical fluid volume trajectories were performed. Twenty-seven eyes (21 with diagnosis of neovascular age-related macular degeneration and one converted during the study), of 15 patients were monitored for 6 months, scanning at 6.2 times/week per eye and yielding 4,435 scans of which 91.2% were eligible for artificial intelligence-based fluid volume quantification. Total number of monitoring weeks before and during the study were 1,555 and 509. The mean (SD) number of weeks per injection before and during home OCT management were 8.0 (4.7) and 15.3 (8.5) (P = 0.004), respectively. The mean (SD) visual acuity change before and during home OCT-based management was 3.5 (12.0) letters and 0.0 (9.5) letters (P = 0.45), respectively, showing no significant impact on visual acuity. For the first time, remote patient monitoring with a home OCT allowed personalized management of neovascular age-related macular degeneration. This study showed significant reduction in treatment burden while maintaining stable visual acuity.

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.

Treat-and-Extend Versus Pro re nata Regimens of Ranibizumab and Aflibercept in Neovascular Age-Related Macular Degeneration: A Comparative Study from Routine Clinical Practice.

Anti-vascular endothelial growth factor (VEGF) is generally given using pro re nata or "treat-and-extend" (T&E) regimens for neovascular age-related macular degeneration (nAMD). Randomized clinical trials have reported that T&E is superior to Pro re nata (PRN), but results from clinical trials may not always be replicated in clinical practice. Real-world data comparing T&E and PRN regimens for nAMD are limited. The objective of this work was to report 24-month outcomes of PRN versus T&E regimens for ranibizumab and aflibercept to treat nAMD in routine clinical practice. We conducted a retrospective analysis of data from a prospectively designed observational outcomes registry, the Fight Retinal Blindness! Project (FRB). Treatment-naïve eyes starting nAMD treatment with at least three injections using a T&E or PRN regimen were tracked by using the FRB. The primary outcome was the mean change in visual acuity (VA) measured by the number of letters read on a logarithm of the minimum angle of resolution chart at 2years versus baseline. The secondary outcome was the number of injections at 2years. From January 1, 2015 to January 31, 2019, 3313 eyes from 2948 patients with nAMD were included: 1243 eyes from 1065 patients were classified as PRN and 2070 eyes from 1935 patients started a T&E regimen. At 24months, patients on the T&E regimen experienced significantly greater mean (95% confidence interval) improvement in VA than those on PRN (+ 4.2 [3.1, 5.2] vs. + 1.3 [0.1, 2.6] letters; p < 0.001), with more injections (14.9 standard deviation(SD) 4.3) vs. 9.8(SD 4.3); p < 0.001). Eyes treated with a T&E regimen had better VA outcomes from VEGF inhibitors than eyes treated PRN. This large real-world data assessment supports previous data from randomized clinical trials that the T&E regimen delivers better outcomes than PRN.

The effect of four loading intravitreal aflibercept injections on macular fluid in treatment-naïve neovascular age-related macular degeneration

PurposeTo evaluate the effect of four versus three loading aflibercept injections on macular fluid resolution and visual acuity (VA) in exudative neovascular AMD (nAMD).MethodsMulticentre, retrospective cohort study of treatment naïve nAMD eyes undergoing 3 versus 4 loading doses of aflibercept. Change in VA and fluid resolution on optical coherence tomography (OCT), were evaluated at 8 weeks post loading. The primary outcome was proportion of patients with no intraretinal (IRF) and/or subretinal (SRF) fluid at central 1 mm and whole macula at 8 weeks after loading. Data were summarised with mean ± SD for continuous variables, and n (%) for categorical variables.ResultsData from 995 patients was analysed (355 patients − 4 loading doses and 640–3 loading doses). At 8 weeks post 4 loading doses proportion of eyes with neither IRF nor SRF, no IRF and no SRF were 62.8%, 88.7% and 79.2% at fovea versus 56.1%, 87.9% and 69.9% in the whole macula, respectively. Fluid resolution at both fovea and macula were significantly higher in eyes with 4 loading injections versus 3 (p = 0.0001). The mean VA change was +4.0 (±11.3) and +5.4(±13.3) letters for 3 and 4 loading doses groups (p = 0.09).ConclusionFour loading dose injections of aflibercept results in higher proportion of eyes with total fluid resolution in the central subfield and total macular scan when compared to those receiving 3 loading dose injections at 8 weeks post loading phase. However, the better drying effect of 4th loading dose does not translate into better short-term VA outcomes.

Treatment Outcomes of Intravitreal Aflibercept for Uveitic Macular Edema.

To evaluate the efficacy of intravitreal aflibercept for UME (uveitic macular). A retrospective review of records of patients that received aflibercept for UME from January 2017 to August 2022 was conducted. The primary outcomes were mean change in visual acuity (VA) and central subfield thickness (CST) 6 and 12 months from the start of aflibercept treatment. A total of 16 eyes of 12 patients were included. Indications for treatment included eyes that had previously demonstrated a history of elevated intraocular pressure secondary to a steroid response (n = 10) or a history of non-response or partial response to local corticosteroids (n = 6). Fifteen eyes (94%) demonstrated a reduction in CST after their initial injection. At 6-months, mean VA gain was 2.6 ± 7.7 letters (p = 0.24) from a mean VA of 67.8 ± 10.7 letters at baseline and mean CST improved by 97.6 ± 113.5 μm (p = 0.004) from 458.6 ± 123.1 μm at baseline. Fourteen eyes had 12-months of follow up and received a median of 4 injections over 12 visits. The mean VA at 12-months remained stable compared to baseline (mean change of -1.4 ± 12.5 letters (p = 0.87)) while the CST improved by a mean of 90.9 ± 114.6 μm (p = 0.053) compared to baseline. Intravitreal aflibercept injections resulted in reduced central subfield thickness at all time-points. It appears to be an effective treatment alternative for UME, particularly for patients who are not responsive to local corticosteroids or who have contraindications to corticosteroid treatment.

One-Year Anti-VEGF Therapy Outcomes in Diabetic Macular Edema Based on Treatment Intensity: Data from the Fight Retinal Blindness! Registry

PurposeTo compare one-year outcomes of eyes with diabetic macular edema (DME) treated in routine clinical practice based on the proportion of visits where intravitreal vascular endothelial growth factor (VEGF) inhibitor injections were delivered. DesignCohort study ParticipantsThere were 2288 treatment-naïve eyes with DME starting intravitreal VEGF inhibitor therapy from 31 October 2015 to 31 October 2021 from the Fight Retinal Blindness! international outcomes registry. MethodsEyes were grouped according to the proportion of visits at which an injection was received, Group A with less than the median of 67% (n=1172) versus Group B with greater than the median (n=1116). Main Outcome MeasureMean visual acuity (VA) change after 12 months of treatment. ResultsThe mean (95% confidence interval [CI]) VA change after 12 months of treatment was 3.6 (2.8, 4.4) letters for eyes in Group A versus 5.2 (4.4, 5.9) letters for eyes in Group B (p=0.005). The mean (95% CI) central subfield thickness (CST) change was -69 (-76, -61) μm and -85 (-92, -78) μm for eyes in Group A versus Group B, respectively (p=0.002). A moderate positive correlation was observed between the number of injections received over 12 months of treatment and the change in VA (p<0.001). Additionally, eyes that received more injections had a moderately greater CST reduction. ConclusionsThis registry analysis found that overall VA and anatomic outcomes tended to be better in DME eyes treated at a greater proportion of visits in the first year of intravitreal VEGF inhibitor therapy.

Face-down positioning or posturing after pars plana vitrectomy for macula-involving rhegmatogenous retinal detachments.

Face-down positioning or posturing after pars plana vitrectomy for macula-involving rhegmatogenous retinal detachments.

Visual Outcome and Fluid Changes Between Eyes With Polypoidal Choroidal Vasculopathy Receiving Biosimilar CKD-701 or Reference Ranibizumab Therapy: A Post Hoc Analysis of a Phase 3 Randomized Clinical Trial

Purpose To compare the visual outcome and fluid features of a proposed biosimilar, CKD-701, versus the reference ranibizumab in eyes with polypoidal choroidal vasculopathy (PCV). Methods This was a post hoc analysis of a phase 3 randomized clinical trial assessing the efficacy and safety of CKD-701 and ranibizumab. A total of 73 PCV eyes were assigned randomly to either CKD-701 (36 eyes) or ranibizumab (37 eyes). The mean changes in best-corrected visual acuity (BCVA), central retinal thickness (CRT), pigment epithelial detachment (PED) volume, and fluid features were compared. Results After three loading injections, the mean change in BCVA (letters) was +7.50 in the CKD-701 group and +6.32 in the ranibizumab group (p = .447). The changes in CRT and PED volume of the CKD-701 group (−107.25 ± 102.66 μm and −0.22 ± 0.46 mm3) were similar to those of the ranibizumab group (−96.78 ± 105.00 μm and −0.23 ± 0.54 mm3) (p = .668 and p = .943, respectively). Proportions of eyes with subretinal, intraretinal and sub-retinal pigment epithelium (RPE) fluids after three loading injections were not different between CKD-701 group (33.3%, 13.9% and 42.9%) and ranibizumab group (51.4%, 16.2% and 40.0%) (p = .071, p = 1.000 and p = .808). The visual and anatomical changes were similar between two groups at month 6 and 12 (all, p > .05). Conclusion Biosimilar CKD-701 monotherapy resulted in comparable visual and anatomical changes to those achieved with reference ranibizumab in PCV eyes.

Displacement of Submacular Hemorrhage Using Subretinal Cocktail Injection versus Pneumatic Displacement: A Real-World Comparative Study

Introduction: The objective of this study was to compare the outcome of submacular hemorrhage (SMH) displacement using pneumatic displacement with intravitreal expansile gas versus pars plana vitrectomy (PPV) with subretinal injection of tissue plasminogen activator (tPA), anti-vascular endothelial growth factor (VEGF) agent, and air as primary surgery. Methods: Retrospective interventional case series of 63 patients who underwent surgical displacement of SMH secondary to neovascular age-related macular degeneration (nAMD) or polypoidal choroidal vasculopathy (PCV) from May 1, 2015, to October 31, 2022. Medical records were reviewed for diagnosis, logMAR visual acuity (VA), central subfield thickness (CST), and postoperative displacement rates and complications up to 12 months after operation. Results: The diagnosis was nAMD in 24 (38.1%) and PCV in 39 (61.9%) eyes. There were 40 (63.5%) eyes in the pneumatic displacement group (38 received C3F8, 2 received SF6) and 23 (36.5%) eyes in the subretinal cocktail injection. Mean baseline VA was 1.46 and 1.62, respectively (p = 0.404). The subretinal injection group had more extensive SMH (p = 0.005), thicker CST (1,006.6 μm vs. 780.2 μm, p = 0.012), and longer interval between symptom and operation (10.65 vs. 5.53 days, p < 0.001). The mean postoperative VA at 6 months was 0.67 and 0.91 (p = 0.180) for pneumatic displacement and subretinal injection groups, respectively, though VA was significantly better in the pneumatic group at 12-month visit (0.64 vs. 1.03, p = 0.040). At least 10 mean change in VA were >10 letters gain in both groups up to 12 months. Postoperative CST reduction was greater (625.1 μm vs. 326.5 μm, p = 0.008) and complete foveal displacement (87.0% vs. 37.5%), p < 0.001, odds ratio [OR] = 11.1) and displacement to arcade or beyond (52.5% vs. 17.5%, p = 0.009, OR = 5.15) were more frequent in the subretinal injection group. Two patients with failed pneumatic displacement were successfully treated with subretinal cocktail injection as a second operation. Conclusion: Surgical displacement of SMH leads to clinically meaningful improvement in VA. PPV with subretinal cocktail injection is more effective than pneumatic displacement in displacing SMH with similar safety profile despite longer interval before operation, higher CST, and more extensive SMH at baseline. Retinal surgeons could consider this novel technique in cases with thick and extensive SMH or as a rescue secondary operation in selected cases.

Bevacizumab vs Ranibizumab in Macular Edema due to Retinal Vein Occlusion: Short-term Outcomes

Introduction &amp; ObjectivesBevacizumab or Ranibizumab was widely used as therapy for macular edema (ME) in retinal veinocclusion (RVO) and diabetic retinopathy. The purpose of this study was to comparing short-termoutcomes for patients who received intravitreal Bevacizumab (IVB) injection or Ranibizumab (IVR)for ME due to RVO&#x0D; MethodsThis was observational, cross sectional study comparing patients received IVB or IVR. Primaryoutcomes data (visual acuity and central macular thickness/CMT) and secondary outcomes data(number injection and intra ocular pressure/IOP) were collected at baseline and 3 months afterinjection&#x0D; ResultsThere were 4 eyes in each group. There were no significant difference in mean change of visualacuity (-0.275±0.25 vs -0.15±0.5 logMAR; p=0.676) and CMT (-171.50±129.08 vs -98.25±37.67 um;p=0.345) in IVB vs IVR groups. There were also no significant difference in mean change of IOP(2±2.16 vs 2±4.69 mmHg; p=1) and number of injection (2.25±0.50 vs 1.75±0.9; p=0.401 ) in bothgroups.&#x0D; ConclusionIn short-term both IVB and IVB have relative similar outcomes on increasing visual acuity anddecreasing CMT in ME due to RVO

The impact of COVID-19 on aflibercept treatment of neovascular AMD in Sweden – data from the Swedish Macula Register

BackgroundThe purpose of the study was to compare the real-world aflibercept treatment and visual outcomes, and to examine the adherence to pandemic guidelines in two groups of patients with treatment-naïve neovascular age-related macular degeneration (nAMD) before and during the first year of the COVID-19 pandemic in Sweden up to the 1-year follow-up.MethodsThis is a retrospective observational study including 2915 treatment naïve eyes with nAMD. Using data from the Swedish Macula Register (SMR), 1597 eyes initiating treatment between 1 July 2018 and 31 January 2019 (pre-pandemic group) were compared with 1318 eyes starting treatment between 1 February and 31 August 2020 (pandemic group). The eyes were then followed for 1 year ± 2 months, hence the first group was unaffected by the pandemic while the second group was affected. The focus was on baseline characteristics, visual acuity (VA) change from baseline, number of injections, treatment regimen, number of appointments and the frequency and length of appointment delays. The Wilcoxon Signed-Rank Test was used to compare baseline VA to follow-up VA within the respective groups. The Mann-Whitney U-test and Fisher’s exact test were used to compare outcomes between the groups.ResultsBaseline characteristics were similar between the two groups. The percentage of eyes with an available follow-up VA after 1 year was 58% in the pre-pandemic group vs. 44% in the pandemic group. VA in the pre-pandemic group had increased significantly after 1 year, from 62.2 ± 14.1 letters to 64.8 ± 16.1 letters (n = 921); p < 0.0001. In the pandemic group, VA increased from 61.1 ± 15.8 to 64.9 ± 16.9 (n = 575); p < 0.0001. There was no significant difference in mean VA change between the groups; p = 0.1734. The pre-pandemic group had significantly more delays than the pandemic group, 45% vs. 36%; p < 0.0001.ConclusionsThe pre-pandemic and pandemic groups had similar VA gains at 1-year follow-up, but with a reduced number of available VA in the pandemic group. Clinics were able to implement and prioritize injection visits excluding VA measurements, helping to reduce delays and maintain VA gains during the COVID-19 pandemic.

XTEND: Two-Year Results from a Global Observational Study Investigating Proactive Dosing of Intravitreal Aflibercept in Neovascular Age-Related Macular Degeneration.

XTEND (NCT03939767) is a multicenter, observational, prospective study of patients with treatment-naïve neovascular age-related macular degeneration (nAMD) in routine clinical practice. The study aims to examine treatment outcomes of proactive intravitreal aflibercept (IVT-AFL) treatment regimens (fixed dosing or treat-and-extend) according to local marketing labels. Study eyes received IVT-AFL injections as per the local label. The mean changes in best-corrected visual acuity (BCVA) and central subfield thickness (CST) from baseline to month (M) 12 and M24 were measured and stratified by baseline factors. Treatment exposure and safety data were evaluated. Statistical analysis was descriptive. Overall, 1466 patients from 17 countries were treated. For the overall population, the mean ± standard deviation (SD) age was 78.7 ± 8.5 (range 50-100)years, and 891 patients (60.8%) were female. The mean ± SD baseline BCVA was 54.3 ± 20.3 letters and CST was 374 ± 126µm. At M12 and M24, mean (95% confidence interval [CI]) BCVA change was + 4.3 (3.4, 5.3) and + 2.3 (1.3, 3.3) letters, respectively. Mean (95% CI) CST was - 106 (- 114, - 99) μm and - 109 (- 117, - 102) μm at M12 and M24, respectively. At M24, 41.5% of patients had a BCVA ≥ 70 letters. Patients received a mean ± SD of 7.7 ± 2.7 injections by M12 and 10.8 ± 5.0 injections by M24 (3.1 injections between M12 and M24). Adverse events were consistent with the known safety profile of IVT-AFL. The 24-month results indicate that, in routine clinical practice, a proactive IVT-AFL regimen achieves functional improvements in patients with treatment-naïve nAMD. The proportion of patients achieving ≥ 70 letters at M24 increased, and patients with baseline BCVA ≥ 70 letters maintained vision regardless of the followed IVT-AFL label. ClinicalTrials.gov identifier: NCT03939767. A video abstract is available for this article. Supplementary file2 (MP4 364624 KB).

Effect of Race and Insurance Status on Treatment and Outcomes in Diabetic Retinopathy: Analysis of 43 274 Eyes Using the IRIS Registry.

Purpose: To examine disparities in visual acuity (VA) outcomes 1 year and 2 years after initiation of diabetic retinopathy (DR) or diabetic macular edema (DME) treatment in patients based on race/ethnicity and insurance status, accounting for disease severity. Methods: This retrospective analysis used the IRIS Registry and included DR patients older than 18 years with documented antivascular endothelial growth factor (anti-VEGF) treatment and VA data for at least 2 years. International Classification of Diseases, Tenth Revision, Clinical Modification codes were used to determine the severity of DR and DME presence. VA outcomes were assessed using multivariable linear regressions and anti-VEGF drug use by multivariable logistic regressions, with race and insurance status as independent variables. Main outcome measures comprised the mean VA change at 1 year and 2 years and percentage of patients treated with bevacizumab. Results: The study included 43 274 eyes. White patients presented with a higher mean VA and lower mean DR severity than Black patients and Hispanic patients. Multivariable logistic regression showed Hispanic patients were significantly more likely to be treated with bevacizumab than White patients across all insurance types, controlling for disease severity and VA. After 1 year, the letter improvement was 1.73, 1.33, and 1.13 in White patients, Black patients, and Hispanic patients, respectively. Multivariable linear regression suggested that across races, Medicaid-insured patients had significantly smaller gains in VA than privately insured patients. Conclusions: Race-based and insurance-based differences in 1-year and 2-year outcomes after anti-VEGF treatment for DR and anti-VEGF treatment patterns suggest a need to ensure earlier and more effective treatment of minority and underserved patients in the United States.

Visual and anatomical outcomes following intravitreal treatment of macular oedema secondary to retinal vein occlusion

Aims/Purpose: We sought to measure the visual and anatomical outcomes of patients treated for macular oedema secondary to retinal vein occlusion (RVO) with anti‐vascular endothelial growth factor (VEGF) medications or intravitreal steroids.Methods: We retrospectively identified eyes with RVO in our Trust treated with anti‐VEGF injections or intravitreal steroids. Patient data such as age, gender and visual acuity (VA) were obtained from electronic patient records. Central retinal thickness (CRT) was measured via optical coherence tomography (OCT). Macular perfusion and ischaemia were assessed by fundus fluorescein angiography (FFA) on initiation of treatment. VA and CRT data were obtained for 24 months from starting treatment with anti‐VEGF injections or intravitreal steroids.Results: 56 eyes (26 with branch RVO (BRVO), 22 with central RVO (CRVO) and 8 with hemi‐RVO (HRVO)) were identified and followed up for 24 months after starting anti‐VEGF treatment or intravitreal steroids. Mean change in VA at 24 months was +7.0 ± 16.3 letters among CRVO eyes and + 3.9 ± 21.3 letters among BRVO eyes, whereas for HRVO mean VA change was +20.3 ± 16.8 letters. Mean CRT decreased by 334.2 ± 163.5 μm in eyes with CRVO, 147.1 ± 193.1 μm in eyes with BRVO and 300.3 ± 118.6 μm in eyes with HRVO. Furthermore, we achieved VA stabilization or improvement in 91% of eyes treated under ‘optimal’ conditions, in line with the meta‐analysis of studies on RVO outcomes by Hunter &amp; Williams (2022).Conclusions: Current Trust protocols for intravitreal steroids and anti‐VEGF injections show good outcomes in RVO patients. Patients on treatment should be followed up regularly to minimize delays, while early treatment agent switches should be pursued if VA is dropping or macular oedema persists.ReferencesHunter A, Williams M. Long‐term outcomes for patients treated for macular oedema secondary to retinal vein occlusion: a systematic review. BMJ Open Ophthalmol. 2022;7(1):e001010. doi:10.1136/bmjophth‐2022‐001010

Real-world visual acuity outcomes for patients with naïve neovascular age-related macular degeneration treated with aflibercept, ranibizumab, or bevacizumab in the Republic of Korea.

To compare the visual outcomes of different anti-vascular endothelial growth factor (VEGF) drugs, including aflibercept, ranibizumab, and bevacizumab, in a real-world setting in Korea. We collected data from patients who received monotherapy using one of these three anti-VEGF drugs as naïve treatment after being diagnosed with neovascular age-related macular degeneration. The number of injections and visual acuity (VA) outcomes of each cohort were obtained and pairwise comparisons were performed using propensity score matching. A total of 254 aflibercept, 238 ranibizumab, and 282 bevacizumab treatment-naïve eyes were included. The mean VA change at 3 years for all cohorts combined was -1.8 letters, and the mean number of injections was 9.4. In the direct comparison of the three drugs, the mean change in the VA letter score was +2.0 letters for aflibercept and -11.7 letters for bevacizumab (P < 0.001). The number of aflibercept injections was significantly higher than the number of bevacizumab injections (P = 0.002). The visual outcomes for aflibercept and ranibizumab were +4.7 letters and -1.9 letters, respectively, and comparable results were obtained (P = 0.13). The VA outcomes for ranibizumab and bevacizumab were also not significantly different (P = 0.09). The numbers of injections for aflibercept, ranibizumab, and bevacizumab were 10.8, 6.7, and 8.8, respectively. Significant differences were observed between the injection frequencies comparisons of aflibercept and ranibizumab and ranibizumab and bevacizumab (P < 0.001 and P = 0.002, respectively). In the Korean clinical medical environment, which included various confounding factors, especially socioeconomic ones, the aflibercept VA outcome was significantly better than that of bevacizumab, and aflibercept injections were the most numerous. These real-world data imply that the drug effect as well as the environment in which the drug can be sufficiently used affected patient final VA scores.

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.

Macular Neovascularization Type Influence on Anti-VEGF Intravitreal Therapy Outcomes in Age-Related Macular Degeneration

PurposeTo evaluate the influence of macular neovascularization (MNV) lesion type on 12 months clinical outcomes in treatment-naïve eyes with age-related macular degeneration (nAMD) eyes treated with anti-vascular endothelial growth factor (VEGF) drugs nationwide. DesignMulticenter national nAMD database observational study. SubjectsOne thousand six-hundred six treatment-naïve nAMD eyes (1330 patients) undergoing Anti-VEGF therapy for 12 months nationwide. MethodsDemographics, visual acuity (VA) in logarithm of the minimum angle of resolution (logMAR) letters, number of injections and visits data was collected using a validated web-based tool. Neovascular lesion phenotype was classified as type 1 (T1, n=711), type 2 (T2, n=505), type 3 (T3, n=315) and aneurysmal type 1 (A-T1, n=75), according to the new proposed consensus classification. Main outcome measuresMean VA change at 12 months, final VA at 12 months, number of injections, time to lesion inactivation. ResultsA total of 1606 treatment-naïve nAMD eyes (1330 patients) received a median of 7 injections over 12 months. Mean (±standard deviation) baseline VA was significantly lower for T2 (49.4±23.5 letters) compared to T1 (57.8±20.8) and T3 (58.2 ±19.4)(both p<0.05) lesions. Mean VA change at 12 months was significantly greater for A-T1 (+9.5 letters) compared to T3 (+3.1 letters, p<0.05). T3 lesions had fewer active visits (24.9%) than the other lesion types (T1 30.5%, T2 32.6%, A-T1 27.5%, all p<0.05). Aflibercept was the most used drug in A-T1 lesions (70.1%) and ranibizumab in T1 (40.7%), T2 (57.7%) and T3 (47.6%) lesions. ConclusionsThis study highlights the relevance of MNV type on clinical outcomes in nAMD and reports significant differences in baseline VA, VA change and lesion activity at 12 months. This report provides data about lesion-specific clinical features, which may guide the management of nAMD cases and potentially support a personalized clinical decision making in these patients.

Maintenance of Vision Needed to Drive after Intravitreal Anti-VEGF Therapy in Patients with Neovascular Age-related Macular Degeneration and Diabetic Macular Edema

To evaluate the association between intravitreal anti-VEGF therapy and visual acuity (VA)/driving vision maintenance over 4 years in patients with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME). Retrospective, observational, clinical practice cohort study using data from the Vestrum Health database. Initial diagnosis (January 1, 2014 to June 30, 2019) of nAMD or DME and ≥ 1 year of treatment/follow-up history. The VA analysis required 4 years of treatment/follow-up history. For the driving vision maintenance analysis, patients required Snellen VA of 20/40 or better at baseline and for ≥ 6 months during year 1 after index intravitreal anti-VEGF treatment in the better-seeing eye. A loss-of-driving event was the first clinic visit with VA worse than 20/40 sustained for ≥ 6 consecutive months. Kaplan-Meier analyses estimated the probability of maintaining driving vision over 4 years stratified by year-1 injection number. Cox proportional hazard models examined associations between baseline clinical characteristics and year-1 injection frequency and the risk of losing driving vision. Mean change in VA over time and by baseline VA, driving vision maintenance probability over time and stratified by anti-VEGF injection frequency, and baseline factors predictive of driving vision maintenance. In year 1, the nAMD and DME cohorts gained 8.5 and 9.5 ETDRS letters, respectively. Between years 1 and 4, patients with nAMD and DME lost 6.6 and 2.7 ETDRS letters, respectively. The probability of maintaining driving vision over 4 years was 56% (nAMD) and 72% (DME); among patients who received 1 to 5, 6 to 7, and ≥ 8 anti-VEGF injections in year 1, corresponding probabilities were 50%, 56%, and 65% (nAMD; P < 0.001) and 63%, 72%, and 77% (DME; P < 0.001). Baseline factors associated with driving vision loss included older age, worse index VA, geographic atrophy (nAMD), and worsening baseline diabetic retinopathy (DME). Older age and worse index VA were risk factors for driving vision loss, whereas a greater year-1 injection number was associated with driving vision maintenance through year 4, supporting early initiation and frequent anti-VEGF injections for maintaining driving vision in nAMD or DME. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.