The use of intravitreal aflibercept injection (IAI) vs a sham treatment as prophylaxis against developing exudative age-related macular degeneration (AMD) in high-risk eyes showed similar results, a study, published in JAMA Ophthalmology, has found.
The single-masked sham-controlled randomized clinical trial examined if an anti-vascular endothelial growth factor (VEGF) agent offers a prophylactic effect in high-risk eyes with intermediate dry AMD from converting to exudative AMD (wet AMD), thus lowering visual loss risk, at 24 months follow-up. It was performed in 4 clinical sites in the United States. Researchers reviewed 128 patients who had intermediate AMD in 1 eye and wet AMD in the other; 127 (63 in the 2 mg IAI group, and 64 in the sham quarterly injection group, at 1:1 randomization) were included in the primary analysis (68 men [53.5%]; mean age, 76.5±8.1 years).
Between the 2 groups, baseline demographic and clinical characteristics were balanced, and treatment was performed from 2015 to 2019. The study’s primary end-point was the number of patients who had converted to wet AMD by month 24, characterized by the development of choroidal neovascularization, as assessed by leakage on fluorescein angiography and fluid on spectral-domain optical coherence tomography (SD-OCT).
The report shows that by 24 months, 6 patients (9.5%) in the IAI group and 7 (10.9%) in the sham group had developed wet AMD (P =.98).
Patients with a history of wet AMD for longer than 2 years in their fellow eye at baseline showed a lower rate of conversion to wet AMD in the study eye compared with those with a history of wet AMD for 2 years or less in the fellow eye, the report says.
The safety profile was similar to previous studies of anti-VEGF treatments. Further research is needed to learn more about why and how conversion to wet AMD occurs, the study reports.
The study was limited in that researchers saw a lower-than-expected conversion rate, which means the study “could have been underpowered to detect a difference in conversion rate between the 2 treatment groups.”
Disclosure: This research was supported by Regeneron. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosure.
Heier JS, Brown DM, Shah SP, et al. Intravitreal aflibercept injection vs sham as prophylaxis against conversion to exudative age-related macular degeneration in high-risk eyes: a randomized clinical trial. JAMA Ophthalmol. Published online March 18, 2021. doi:10.1001/jamaophthalmol.2021.0221.