The average patient with neovascular age-related macular degeneration (nvAMD) would not qualify for the trials that determine current standards of care. Clinical trial methodology could be to blame for real-world patients having worse outcomes than expected. Accurate knowledge of real-world outcomes is essential to health policy, practice management, and physician reimbursement.
Clinical data and angiograms from 1239 eyes were analyzed. Only 48% of eyes would have been eligible for CATT; 41% for LUCAS; 37% for HARBOR, and only 36% eligible for VIEW-1 clinical trials. The most common reasons for ineligibility were lesion characteristics and prior anti-VEGF therapy. “CATT trial-eligible” eyes gained mean 8.7 ETDRS letters at 12 months, after median 10 injections, and gained mean 7.8 ETDRS letters at 24 months, with median additional 7 injections. These results are comparable to what is expected from the CATT trial. Trial-ineligible eyes at 24 months, by contrast, showed significantly worse median visual acuity (VA), were less likely to have improved VA, gained fewer ETDRS letters, were less likely to achieve 20/40 or better, were more likely to have 20/200 or worse, and received significantly fewer anti-VEGF injections. Even when applying Vestrum-analysis methodology, outcomes consistent with clinical trials were observed when analysis was limited to trial-eligible patients.
