TY - JOUR
T1 - SCORE Study Report 3. Study Design and Baseline Characteristics
AU - Ip, Michael S.
AU - Oden, Neal L.
AU - Scott, Ingrid U.
AU - VanVeldhuisen, Paul C.
AU - Blodi, Barbara A.
AU - Figueroa, Maria
AU - Antoszyk, Andrew
AU - Elman, Michael
N1 - Funding Information:
Supported by the National Eye Institute (National Institutes of Health, Department of Health and Human Services) grants 5U10EY014351, 5U10EY014352, and 5U10EY014404. Support also provided in part by Allergan, Inc through donation of investigational drug and partial funding of site monitoring visits and secondary data analyses.
PY - 2009/9
Y1 - 2009/9
N2 - 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 (∼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 (∼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.
AB - 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 (∼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 (∼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.
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U2 - 10.1016/j.ophtha.2009.03.022
DO - 10.1016/j.ophtha.2009.03.022
M3 - Article
C2 - 19619896
AN - SCOPUS:69249229571
SN - 0161-6420
VL - 116
SP - 1770-1777.e1
JO - Ophthalmology
JF - Ophthalmology
IS - 9
ER -