Clinical trials are performed to develop new and better treatment methods. They are also a means for patients to receive expensive treatment. This fact is especially relevant for elderly patients suffering from neovascular age-related macular degeneration (AMD).
Previous studies, such as the Vascular Endothelial Growth Factor Trap-Eye: Investigation of Efficacy and Safety in Wet AMD (VIEW) studies, have shown that many elderly patients are excluded from clinical trials. This exclusion is due to possible study complications. This study evaluates the number of patients excluded from the VIEW studies and the specific reasons for study exclusion.
This retrospective, observational study consisted of 512 eyes of 463 patients diagnosed with neovascular AMD. All cases were previously untreated. The proportion of the cases that did not meet eligibility were evaluated. The most common reasons for not meeting eligibility were then further evaluated by neovascular AMD subtype: typical neovascular AMD, polypoidal choroidal vasculopathy (PCV), and type 3 neovascularization.
Of the participants, 229 (44.7%) did not meet study eligibility. For 169 (33.0%) eyes, the reason stated was good or poor visual acuity. Overall, 47 eyes (9.5%) were not eligible due to the presence of subretinal hemorrhage. Other reasons for exclusion were a fovea-involving scar or fibrosis in patients with typical neovascular AMD, subretinal hemorrhage in eyes with PCV, and vascular diseases of the retina in the case of type 3 neovascularization.
Nearly half (44.7%) of the 463 potential study participants were turned away for ineligibility. These data suggest that clinical trial conclusions may not reflect real-world patient outcomes. More inclusive study criteria are needed so that study conclusions will be relevant for a larger portion of patients who suffer from neovascular AMD .
Source: Kim, J. H., Kim, J. W., & Kim, C. G. (2021). Eyes that Do Not Meet the Eligibility Criteria of Clinical Trials on Age-Related Macular Degeneration: Proportion of the Real-World Patient Population and Reasons for Exclusion. Journal of Ophthalmology, 2021, 1–8. https://doi.org/10.1155/2021/6635467