Original articleSurgery for subfoveal choroidal neovascularization in age-related macular degeneration: Ophthalmic findings*
: SST report no. 11
Section snippets
Materials and methods
The members of an independent Data and Safety Monitoring Committee, appointed late in 1996 by the Director of the National Eye Institute (National Institutes of Health, U.S. Department of Health and Human Services, Bethesda, Maryland), reviewed findings from the SST pilot study for similar patients and approved the SST design and methods before enrollment of patients was initiated in the SST Group N Trial in July 1998. Institutional review boards at all participating institutions reviewed and
Results
From July 13, 1998 until accrual ended on September 30, 2001, 454 patients (454 eyes) enrolled in the SST Group N Trial; 226 patients were assigned to the surgery arm and 228 patients to the observation arm. Based on central review of baseline photographs and other baseline data, 77 eyes (17%) (41 in the surgery arm and 36 in the observation arm) were judged not to meet 1 or more of the strict criteria for eligibility. One eye in the surgery arm had baseline VA worse than Snellen equivalent
Discussion
The SST Research Group was unable to demonstrate any benefit to submacular surgery compared with observation with respect to VA, reading speed with enlarged text, or contrast threshold in eyes with subfoveal choroidal neovascularization and age-related macular degeneration enrolled and followed in the Group N Trial. Both VA and reading speed of study eyes declined over time in both treatment arms. Despite high rates of recurrent choroidal neovascularization, eyes in the surgery arm maintained
Acknowledgment
The Submacular Surgery Trials Research Group gratefully acknowledges the contributions of ophthalmologists who referred patients to the study and, in particular, of patients who enrolled, agreed to random assignment to treatment arm, and returned for scheduled follow-up examinations to benefit future patients.
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Cited by (0)
Manuscript no. 240390.
Pertinent financial interests reported by members of the SST Research Group are summarized in Appendix 2; individual statements are on file in the SST Chairman's Office, Baltimore, Maryland. The Submacular Surgery Trials are sponsored by the National Eye Institute, National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland (cooperative agreements U10 EY11547, EY11557, EY11558 with the Johns Hopkins University, Baltimore, Maryland). Participating clinical centers were supported by contracts with the Johns Hopkins University.
- *
A list of the members of the Group who contributed data for the 2 SST clinical trials for patients with age-related macular degeneration appears in “Appendix 1.” The members of the Writing Committee for this report who take responsibility for its content on behalf of the SST Research Group are included at the end of that list. Documentation of approval of the manuscript submitted for publication by all individuals listed is on file at the SST Coordinating Center, Baltimore, Maryland.