SCORE Study report 3: study design and baseline characteristics
Michael S Ip, Neal L Oden, Ingrid U Scott, Paul C VanVeldhuisen, Barbara A Blodi, Maria Figueroa, Andrew Antoszyk, Michael Elman, SCORE Study Investigator Group, Michael S Ip, Neal L Oden, Ingrid U Scott, Paul C VanVeldhuisen, Barbara A Blodi, Maria Figueroa, Andrew Antoszyk, Michael Elman, SCORE Study Investigator Group
Abstract
Objective: To describe the baseline characteristics of the participants in the Standard Care versus COrticosteroid for REtinal Vein Occlusion (SCORE) Study and to compare with cohorts from other retinal vein occlusion trials. The design of the SCORE Study is also described.
Design: Two, multicenter, Phase III, randomized clinical trials, one involving participants with central retinal vein occlusion (CRVO) and one involving participants with branch retinal vein occlusion (BRVO).
Participants: A total of 682 participants, including 271 with CRVO and 411 with BRVO.
Methods: Demographic and study eye characteristics are summarized and compared between the CRVO and BRVO study participants.
Main outcome measures: Baseline ophthalmic characteristics, including visual acuity and duration of macular edema before enrollment, and medical history characteristics, including diabetes mellitus and hypertension.
Results: In the CRVO trial, at baseline, mean visual acuity letter score was 51 ( approximately 20/100), mean optical coherence tomography (OCT)-measured central subfield thickness was 595 microns, mean area of retinal thickening in the macular grid on color photography was 12.3 disc areas (DA), and mean area of fluorescein leakage was 11.0 DA. In the BRVO trial, at baseline, mean visual acuity letter score was 57 ( approximately 20/80), mean OCT-measured central subfield thickness was 491 microns, mean area of retinal thickening in the macular grid on color photography was 7.5 DA, and the mean area of fluorescein leakage was 6.1 DA.
Conclusions: Differences observed in baseline visual acuity, OCT-measured retinal thickness, area of retinal thickening on color photography, and area of fluorescein leakage support the evaluation of CRVO and BRVO in separate trials.
Financial disclosure(s): The authors have no proprietary or commercial interest in any of the materials discussed in this article.
Conflict of interest statement
None of the authors has a financial interest in the subject matter of this article.
Source: PubMed