Purchase this article with an account.
M.M. Altaweel, L. Hubbard, R. Gagnon, Eyetech Study Group; The Utility of Optical Coherence Tomography in Eligibility Determination for Clinical Trials of Macular Disease Therapy . Invest. Ophthalmol. Vis. Sci. 2005;46(13):1577.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
Purpose: To examine the importance of retinal evaluation with OCT as a method to select appropriate subjects for clinical trials. Methods: Recent clinical trials studying the effect of a VEGF inhibitor on various macular disorders have incorporated Retinal thickening as a secondary endpoint. OCT has been utilized to evaluate the retinal thickness and morphology of the macula, in addition to Fundus photography and Fluorescein angiography. Eligibility determination with OCT included selection of subjects with above a minimum prespecified retinal thickness and excluded subjects with morphological characteristics which would confound the assessment of potential therapeutic effect. Assessment of OCT quality (scan centering, ILM and RPE border detection, and center point standard deviation of < 10%) was included, with reliable scans required for enrollment. Results: In a study evaluating an Anti–VEGF agent for treatment of Diabetic macular edema, OCT demonstrated macular involvement with a minimum center point thickness of 250 um in 187 of 194 screened individuals. In addition to the 7 screen failures due to insufficient macular thickness, 4 were ineligible due to poor scan quality. Overall 11 of 24 (45.8%) of screen failures were due to OCT related issues. OCT morphology evaluation for vitreoretinal interface disorders did not result in any eyes being ineligible. In a study of Macular edema caused by CRVO, 19 of 23 screened eyes were eligible, with 2 ineligible due to poor scan quality. Screening scans were performed twice, yielding a Intraclass correlation coefficient of .950 (.883,.979) at the center point. In a similar study of AMD, of 197 screened eyes, 29 failed due to insufficient retinal thickness on OCT, and 11 failed due to poor quality scans. Conclusions: Macular evaluation with Optical Coherence Tomography is very useful in determining eligibility of subjects for clinical trials. Evaluation of scan quality is a necessary first step to ensure reliable and reproducible data. A preset minimum retinal thickness is often an eligibility criteria to select eyes which have a potential to improve in a measurable manner. Retinal morphology is also graded with OCT for various disorders and is used to prevent entry of eyes with confounding lesions that would preclude improvement with study treatment. OCT will have an expanding role in Eligibility determination and as a secondary endpoint in clinical trials of macular disease therapy.
This PDF is available to Subscribers Only