Abstract
Purpose :
Recent advancements have led to various potential therapeutics for geographic atrophy. A challenge lies in identifying optimal ways to evaluate these therapeutic options while minimizing patient burden. To determine how to optimize clinical trial design for geographic atrophy, we surveyed clinical investigators at leading clinical ophthalmology research institutions.
Methods :
As part of a clinical site feasibility questionnaire, we surveyed ophthalmology specialists at clinics and research institutions throughout the United States (US). We further asked the specialists to comment on how study design could facilitate trials in geographic atrophy. The survey was conducted between July 2017 and April 2020. Answers were compiled and assessed for commonalities.
Results :
Responses were provided by 119 different clinics and research institutions specialized in geographic atrophy clinical trials, from 33 states across the US. Of the 119 sites, 44 commented on how study design could be changed to facilitate clinical trials in geographic atrophy. Of these respondents, 59% noted a reduction in patient burden as the best way to facilitate trials in geographic atrophy (Figure 1) followed by a reduction in site burden (39%). Amongst the top ways suggested to reduce patient burden were reducing visit length (23%), reducing visit frequency (19%), reducing the number of study procedures performed at each visit (19%), adding materials to help explain the trial to patients (12%), and increasing reimbursement for patient transportation (8%) (Figure 2). Other notable approaches to patient burden reduction, totaling 19% of responses when taken together, included milestone gifts for patients, flexible visit scheduling, a higher percentage of patients being assigned active drug over placebo, and an informed consent form that does not require an initial and date on every page.
Conclusions :
Responses from leading clinical research professionals in the United States emphasize the importance of designing trials around reducing patient burden. Considering the demographics of patients with geographic atrophy, reducing patient burden might be vital to facilitating clinical trials for this condition.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.