Patients With RVO Had Anatomic Improvements After Treatment With Intravitreal Aflibercept

Functional and anatomic improvements in patients with retinal vein occlusion (RVO) were seen after patients received intravitreal aflibercept (IVT-AFL) treatment. Treatment-naïve patients were able to see results for 24 months following a decrease in treatment frequency, according to a study published in Ophthalmology Therapy.

Vision loss is a primary effect of RVO, with RVO making up the second most common cause of vision loss. Macular edema is the leading cause of vision loss in patients with RVO. Treatment for branch RVO (BRVO) required further investigation when it came to treating the disorder with IVT-AFL. The AURIGA study aimed to assess the long-term effectiveness of IVT-AFL in an observational study rather than in a randomized controlled trial. This study reported on the results of the AURIGA trial.

Structure of human eye. In side view | Image credit: svetazi - stock.adobe.com

AURIGA spanned 24 months and took place in several countries to evaluate the effectiveness of IVT-AFL in a real-world setting. Patients who were treatment-naïve or had been previously treated for diabetic macular edema or macular edema that was secondary to RVO were the target population for the study. A total of 243 eye clinics from 11 countries enrolled patients from November 24, 2017, through December 17, 2021.

The inclusion criteria for this study were treatment-naïve and previously treated patients who were aged 18 years and older with macular edema that was secondary to RVO. Patients also needed to be treated with IVT-AFL on their physician’s recommendation. Patients who were previously treated could only have received anti-vascular endothelial growth factor other than IVT-AFL or steroids to be eligible. Best-corrected visual acuity (BCVA) was used to assess visual outcomes with conventional VA measurements done in areas where BCVA was not part of the standards of care. Central retinal thickness (CRT) was measured in all patients.

The primary endpoint was the change in VA from baseline to month 12 and the secondary endpoint was the proportion of patients who had gains and losses in VA, the change in CRT, presence of retinal fluid, number of injections, and mean number of visits. Months 6, 12, and 24 were the time points used for evaluation of all endpoints.

There were 562 treatment-naïve patients and 65 previously treated patients included in the AURIGA study to be treated with IVT-AFL. The patients primarily came from France, Germany, Italy, and Taiwan. The mean (SD) age of the cohort was 67.8 (25-95) years, 54.0% were male, and the mean baseline VA was 51 (21.9) letters. Mean baseline CRT was 467 (151) mm.

Patients who were treatment-naïve and previously treated for central RVO (CRVO) had a mean baseline VA of 45.5 (23.8) letters and 46 (23.6) letters respectively compared with 54.7 (19.6) letters and 57.2 (15.5) letters in patients who were treatment-naïve and previously treated for BRVO. The mean change in letters from baseline to month 12 was 12.5 (95% CI, 10.8-14.3) in patients who were treatment naïve and 7.9 (95% CI, 3.3-12.6) letters for patients who had been previously treated.

The treatment-naïve cohort had a quick increase in the mean VA, with 13.4 (95% CI, 11.5-15.3) letters gained from baseline to 6 months in those treated for BRVO. This increase was maintained for 24 months. Patients who were treatment naïve for CRVO had a similar pattern with a 10.7 (95% CI, 7.4-13.9) letter increase by month 6, which was maintained through 12 months. However, there was a slight decrease by month 24 (8.8 letters; 95% CI, 5.3-12.2). Patients who were previously treated had smaller gains when treated for BRVO and CRVO (2.3; 95% CI, –4.9 to 9.5 and 6.7; 95% CI, –2.1 to 15.5 respectively). This increased in month 12 (5.8 and 10.3) but decreased by month 24 (2.3 and 6.8).

Mean CRT decreased in all cohorts, going from a baseline of 506 (163) mm for BRVO and 626 (209) mm for CRVO in treatment-naïve patients having a –300 (248) mm change by month 6 in the CRVO patients that was maintained for 24 months. The BRVO cohort had a similar decrease of ­–216 (176) mm that was maintained through 24 months. The previously treated cohort for BRVO and CRVO had smaller decreases but were maintained for 24 months (–139 [139] mm and –232 [168] mm for 6 months vs –113 [112] mm and –187 [191] mm at 24 months respectively).

There were some limits to this study. The observational and real-world nature of the study led to variable treatment patterns and different evaluating parameters. The previously treated cohort was small and therefore could have had missing data due to these different parameters.

IVT-AFL was found to be effective in patients who were both treatment naïve and had been previously treated for RVO. Long-term sustainability of the results has been found through this study and indicates that greater gains could be had in an environment with more controlled injections.

Reference

Giocanti-Aurégan A, Donati S, Hoerauf H, et al. Real-world management of macular edema secondary to retinal vein occlusion with intravitreal aflibercept: 24-month results from the AURIGA observational study. Ophthalmol Ther. Published online November 4, 2023. doi:10.1007/s40123-023-00830-w