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SY Lee, WC Sheils, J Redd, CN Samy, DM Marcus; Multimodality Transpupillary Thermotherapy and Radiotherapy of Choroidal Neovascular Membranes in Age-Related Macular Degeneration: A Phase I Safety Study . Invest. Ophthalmol. Vis. Sci. 2002;43(13):4411.
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Purpose:To report data regarding the safety of multimodality transpupillary thermotherapy (TTT) and radiotherapy for subfoveal choroidal neovascularization (CNV) complicating age-related macular degeneration (ARMD). Methods:Four eyes of four patients with active subfoveal CNV secondary to ARMD were treated with multimodality TTT and radiotherapy. TTT was administered at 810 nm with an adjustable spot size for 60 second duration and power of 360 to 1000 mW. Within 5 hours after TTT administration, a 6 MV photon beam with a treatment collimating device was used to deliver 20 Gy in 5 fractions at 4 Gy per fraction over 5 consecutive days. Results:Two of four patients treated with multimodality TTT and radiotherapy showed stabilization or improvement in vision at 6 month follow-up. One patient maintained a pretreatment best corrected distance visual acuity of 20/100 and demonstrated decreased leakage of an occult subfoveal CNV at 6 month follow-up. A second patient improved from a pre-entry best corrected distance visual acuity of 20/80 to 20/20 despite no angiographic change in her occult subfoveal CNV at 6 month follow-up. A third patient declined from a pre-entry best corrected distance visual acuity of 20/100 to 20/200 at 6 month follow-up with continued progression of her occult subfoveal CNV. The fourth patient worsened from 20/70 to 20/320 at 6 month follow-up. This patient reported a subjective decrease in vision after receiving TTT but prior to irradiation which was reflected in her rapid decline to 20/400 four weeks after treatment. Despite her decline in vision, fluorescein angiography demonstrated no change in her pigment epithelial detachment at 6 months but a noticeable decrease in hard exudates in comparison to pretreatment fundus photographs. No major safety concerns were observed. Conclusion:Multimodality TTT and external beam irradiation at a dose of 20 Gy in 5 fractions does not demonstrate an obvious safety risk in the treatment of subfoveal CNV complicating ARMD. Further enrollment will assess if multimodality TTT and external beam irradiation is a safe and effective alternative therapy for subfoveal CNV complicating ARMD.
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