The purpose of this application is to obtain support for activities required to plan and organize a multicenter study, the Submacular Surgery Trials (SST), to evaluate surgical removal of subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD), ocular histoplasmosis, or idiopathic causes. Activities for which the SST Planning Committee requests support are: * Development of a manual of procedures, data collection forms, and other materials required to conduct a set of multicenter randomized trials; * Development of procedures and operations handbooks for the SST Coordinating Center, Photograph Reading Center, and Pathology Center; * Creation of an organizational structure to facilitate, guide, and monitor the multicenter SST; * Development of funding proposals for the SST Chairman's Office, Coordinating Center, Photograph Reading Center, Pathology Center, and clinical centers. Five randomized clinical trials are planned: two for new (untreated) subfoveal CNV with AMD, one for recurrent CNV with AMD, one for CNV and large subfoveal hemorrhage with AMD, and one for both new and recurrent CNV secondary to ocular histoplasmosis and idiopathic CNV. Surgery will be compared to focal laser treatment or observation, as deemed appropriate based on review of preliminary data, in each clinical trial. The two treatment arms of each clinical trial will be compared regarding changes over time in visual acuity, reading speed, contrast threshold, and quality of life from baseline and incidence of adverse events that require further treatment or hospitalization. A pilot study now underway will provide information regarding the feasibility of the SST. The SST Planning Committee includes individuals with expertise in vitreoretinal surgery, diagnosis and laser treatment of CNV, ophthalmic pathology, epidemiology, biostatistics, clinical trials, coordinating center and photograph reading center management, and evaluation of ophthalmologic photographs. This pooled expertise will be used to evaluate surgery as a treatment for one of the most important causes of blindness in older individuals, CNV due to AMD. Surgery for subfoveal CNV may have broader applicability than laser treatment, the only treatment so far that has any proven benefit with respect to reducing loss of vision, although only for a select subgroup of cases.
