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J.I. Lim, M. Mahmoud, S.R. Sadda, E. de Juan, Jr., L.B. Levin, A. Frances Walonker; A Pilot Trial of Oral 13-cis Retinoic Acid for Treatment of Occult Choroidal Neovascularization Secondary to AMD . Invest. Ophthalmol. Vis. Sci. 2003;44(13):4995.
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Purpose: To determine safety and efficacy of oral 13-cis retinoic acid as a treatment for occult, subfoveal CNV secondary to AMD. Methods: AMD patients with subfoveal occult CNV were treated with oral 13-cis retinoic acid in a pilot study. Inclusion criteria included visual acuity between 20/ 40 and 20/ 400, fluorescein angiographic subfoveal occult CNV, no prior subfoveal CNV treatment and evidence of recent disease progression. Patients with a history of depression, anemia, hyperlipidemia and liver disease were excluded. Patients received 40 milligrams of oral13-cis retinoic acid b.i.d. for 20 weeks, followed by a drug holiday for 8 weeks, and then 20 weeks of treatment. Baseline and then monthly protocol ETDRS visual acuity, contrast sensitivity, fluorescein angiography, clinical examination, serum 13-cis retinoic acid level, CBC, BUN, creatinine, liver function tests, triglyceride, urine uric acid, urine crystals and urine calcium were performed. Baseline visual acuity and fluorescein angiography were compared with follow-up visits. Fluorescein angiograms were read in a masked fashion for type and size of CNV. Results: Six patients, five men and one woman, ranging in age from 64 to 82 years old (median 72 years) were enrolled. Visual acuity ranged from 20/40 to 20/ 400. Follow-up ranged from 2 to 4 months (median 2 months). Median lines of visual acuity change measured + 1 line at one month, + 0.5 line at 2 months and + 1.0 lines at 3 months. Fluorescein angiography showed decreasing CNV size over time in four of the six eyes. Mean serum 13-cis retinoic acid levels were 0.0312 ug/ml at 1 month, 0.0317 ug/ml at 2 months and 0.0286 ug/ml at 3 months. Conclusions: This ongoing pilot trial shows evidence that eyes with subfoveal occult CNV treated with 13-cis retinoic acid may show stabilization of visual acuity and decreasing CNV lesion size by fluorescein angiography.
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