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J.I. Lim, E. deJuan, S. Sadda, G. Fujii, J. Rossi, L. Levin, A. Walonker; Subretinal Radiation Treatment of Occult Choroidal Neovascularization Due to AMD . Invest. Ophthalmol. Vis. Sci. 2005;46(13):1384.
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© ARVO (1962-2015); The Authors (2016-present)
Purpose: To determine tolerability and safety of subretinal radiation treatment for occult subfoveal CNV in AMD. Methods: In this AMD pilot study, subfoveal active CNV was treated with custom designed subretinal radiation delivery devices delivering 26 Gy over 2 to 3 minutes to CNV and not the overlying retina. Following FDA approval and informed consent, patients underwent ETDRS visual acuity (VA), slit lamp and dilated fundus examinations, OCT and fluorescein angiography. CNV lesion greatest linear dimension (GLD) was required to be < 5400 microns. Patients with other diseases causing visual loss or prior treatment of subfoveal CNV were ineligible. Eligible patients underwent pars plana vitrectomy, insertion of the radiation delivery device into the subretinal space overlying the CNV and an air–fluid exchange. Follow–up visits occurred at 1 day, 1 week and then monthly. Results: Ten eyes of 10 patients (63 to 88 years old) received 26 Gy subretinal radiation to CNV from the subretinal radiation devices. A non–angled probe was used in the initial three patients; a modified angled probe was used in subsequent patients. The procedure averaged 20 minutes. Follow–up ranged from 2 to 9 months (median 3 months). VA was stable/ improved in 33 % (3/ 9) at 1 month, 44 % (4/ 9) at 2 and 3 months. Compared to baseline, GLD of leakage decreased 46 % by 1 month, 64 % by 3 months and 82 % by 6 months. OCT total macular volume decreased 13 % at month 1, 19 % at month 3 and 30 % at month 6. Adverse events included subfoveal RPE tears in 2, subretinal hemorrhage in 4 and a macular hole in one eye. Three events (subretinal hemorrhage (2), macular hole) occurred in 3 eyes treated with the non–angled probe. No retinal detachments or endophthalmitis occurred. The angled probe modification resulted in fewer adverse events and led to further device modifications. Conclusions: The subretinal radiation device was tolerated in these AMD patients and the subfoveal CNV leakage decreased in size. Further work is indicated for assessing impact on VA of this new technology.
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