The purpose of the Submacular Surgery Trials (SST) is to evaluate surgical removal of subfoveal choroidal neovascular lesions secondary to age-related macular degeneration, which is the most prevalent cause of irreversible severe vision loss in Americans over 65, ocular histoplasmosis, and unknown causes in four randomized clinical trials, each for a different lesion type and presumed etiology. Only one eye (study eye) of each patient is expected to be eligible for one of the four SST clinical trials. Patients assigned at random to the control arrn will be managed by either observation (no treatment) or laser photocoagulation, depending upon the type of lesion and the findings from earlier clinical trials of treatment of choroidal neovascularization. The primary outcome for each trial will be change in visual acuity of the study eye from baseline to the two-year examination, with better or same visual acuity as at baseline deemed a successfitl outcome. The principal secondary outcome will be change in health-related quality of life from baseline to the two-year interview, as assessed using the Medical Outcomes Study SF-36 questionnaire. Other outcomes of particular interest include adverse events, such as repeated surgery or other treatment of the study eye and loss of measurable visual acuity in the study eye. A parallel economic analysis of surgical management will be undertaken. Patients will be evaluated for eligibility, treated, and followed for clinical outcomes at 50 to 55 collaborating clinical centers. Other SST centers will be the Study Chairman's Office, responsible for overall leadership and direction of the SST; the SST Coordinating Center, responsible for providing scientific leadership and logistic support to the SST investigative team; and the SST Photograph Reading Center, responsible for assessing the ability of the ophthalmologists to identify and enroll eligible patients and to adhere to the treatment protocol. 1600 patients will be enrolled in the SST in a two-year period and randomly assigned to one of the two treatment arrns of the trial for which eligible by personnel at the SST Coordinating Center. An independent Data and Safety Monitoring Committee will review the data at least twice each year to assess the risks and benefits of surgery. This application is for funding to support the activities of the SST Study Chairman's Office.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10EY011547-04
Application #
2888532
Study Section
Special Emphasis Panel (ZEY1-VSN (01))
Project Start
1996-09-30
Project End
2001-09-29
Budget Start
1999-09-30
Budget End
2000-09-29
Support Year
4
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Johns Hopkins University
Department
Ophthalmology
Type
Schools of Medicine
DUNS #
045911138
City
Baltimore
State
MD
Country
United States
Zip Code
21218
Solomon, Sharon D; Dong, Li Ming; Haller, Julia A et al. (2009) Risk factors for rhegmatogenous retinal detachment in the submacular surgery trials: SST report No. 22. Retina 29:819-24
Submacular Surgery Trials Research Group; Solomon, Sharon D; Jefferys, Joan L et al. (2009) Risk factors for second eye progression to advanced age-related macular degeneration: SST report No. 21 Submacular Surgery Trials Research Group. Retina 29:1080-90
Bass, Eric B; Gilson, Marta M; Mangione, Carol M et al. (2008) Surgical removal vs observation for idiopathic or ocular histoplasmosis syndrome-associated subfoveal choroidal neovascularization: Vision Preference Value Scale findings from the randomized SST Group H Trial: SST Report No. 17. Arch Ophthalmol 126:1626-32
Submacular Surgery Trials Research Group; Mann, Ashley L; Bressler, Susan B et al. (2008) Comparison of methods to identify incident cataract in eyes of patients with neovascular maculopathy: Submacular Surgery Trials Report No. 18. Ophthalmology 115:127-33
Submacular Surgery Trials Research Group; Solomon, Sharon D; Jefferys, Joan L et al. (2007) Incident choroidal neovascularization in fellow eyes of patients with unilateral subfoveal choroidal neovascularization secondary to age-related macular degeneration: SST report No. 20 from the Submacular Surgery Trials Research Group. Arch Ophthalmol 125:1323-30
Submacular Surgery Trials Research Group (2007) Evaluation of minimum clinically meaningful changes in scores on the National Eye Institute Visual Function Questionnaire (NEI-VFQ) SST Report Number 19. Ophthalmic Epidemiol 14:205-15
Grossniklaus, Hans E; Wilson, David J; Bressler, Susan B et al. (2006) Clinicopathologic studies of eyes that were obtained postmortem from four patients who were enrolled in the submacular surgery trials: SST Report No. 16. Am J Ophthalmol 141:93-104
Submacular Surgery Trials Research Group (2006) Comparison of 2D reconstructions of surgically excised subfoveal choroidal neovascularization with fluorescein angiographic features: SST report No. 15. Ophthalmology 113:279.e1-279.e5
Childs, Ashley L; Submacular Surgery Trials Research Group (2005) Effect of order of administration of health-related quality of life interview instruments on responses. Qual Life Res 14:493-500
Solomon, Sharon D; Bressler, Susan B; Hawkins, Barbara S et al. (2005) Guidelines for interpreting retinal photographs and coding findings in the Submacular Surgery Trials (SST): SST report no. 8. Retina 25:253-68

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