As our population gets older, age related macular degeneration ? (AMD) will reach epidemic proportions in the United States. Therapies to ? date have focused on the anti-angiogenic therapy with mixed results. ? Recent studies would suggest that the immune system plays a significant ? role in the pathogenesis of AMD. The composition of drusen, one of the ? earliest clinical findings in AMD, have been extensively investigated. ? Complement, lipids, and lipoproteins B and E are commonly found in ocular ? drusen as they are in atherosclerotic plaques. Hageman et al have proposed ? that drusen are the product of a localized inflammatory response which ? would occur after retinal pigment epithelium injury. Recent reports have ? supported further the notion of the immune system playing a role (but yet ? to be fully defined) in AMD. The age related eye disease study (AREDS) ? evaluated the risk factors for the incidence of advanced age related ? macular degeneration and found that using anti-inflammatory medication ? significantly reduced (Odds Ratio 0.22, C.I. 0.08-0.59) the risk of ? developing the geographic atrophy form of AMD. Experimental models and ? patient material have, to date, suggested a role for macrophages and ? complement. We hypothesize that the underlying mechanism that leads to ? choroidal neovascularization (CNV) is similar to those at play in ? atherosclerosis. If this is the case, then CNV treatment should be ? amenable to new immunomodulatory agents directed against specific parts of ? the immune system.? After therapy with anti-angiogenic agents not leading to a persistent ? remission of choroidal neovascularization due to age related macular ? degeneration, participants will be treated with one of three ? immunomodulatory agents or will be observed in conjunction with their ? continued anti-angiogenic therapy. Thus the participant will continue with ? the anti-angiogenic therapy they are receiving after randomization. We ? hypothesize that this combination therapy will inhibit progression of ? choroidal neovascularization (CNV) associated with age related macular ? degeneration (AMD).This is an open-label, phase II, randomized, single ? center clinical trial of 20 study participants randomized to receive one ? of three immunomodulatory agents or will be observed in conjunction with ? their anti-angiogenic therapy. Patients will be randomized to receive other ? rapamycin, daclizumab, remicade, or observation in conjunction with any ? anti-angiogenic therapy the treating physician deems necessary. Patients ? will be evaluated after 6 months of therapy. While recruitment has not yet been completed and numbers are small, trends may become evident in the near future.
