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DM Marcus, MG Maguire, AM Maguire, SL FineAMDRT Study Group; The Age-related Macular Degeneration Radiotherapy Trial (AMDRT): Baseline Characteristics . Invest. Ophthalmol. Vis. Sci. 2002;43(13):1207.
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Purpose: To describe the baseline characteristics of eyes enrolled in the AMDRT. Methods: Eleven centers enrolled 89 patients in the AMDRT, a randomized clinical pilot trial assessing the efficacy of external beam irradiation (5 x 4 Gy fractions=20Gy; 6 MeV) versus observation in the treatment of new and recurrent subfoveal choroidal neovascularization (CNV) in AMD. Eligibility criteria include visual acuity ≷20/320 and CNV not amenable to MPS laser treatment or photodynamic therapy with verteporfin. Primary outcome measures are change in visual acuity. Secondary outcome measures are fluorescein angiographic response and incidence of side effects. Results: Eighty patients demonstrate new CNV and 9 patients demonstrate recurrent CNV. At baseline, the radiation and observation groups are not different with respect to age (mean 77), gender (57% males and 63% females), race (100% caucasian), and hypertensive status. Baseline visual acutiy is not different (p<0.33) between the groups (45%≷20/80). Flourescein angiographic features are not different between the groups (85% minimally classic or occult CNV; 71% comprised of 25% blood; 80% comprised of <25% fibrosis). Conclusion: The AMDRT will determine if trends exist for a beneficial radiotherapy effect at a dose of 5 x 4 Gy.
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