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D. M. Marcus, H. Singh, M. N. Lott, J. Singh, M. Marcus; Intravitreal Ranibizumab for Non-Asian Polypoidal Choroidal Vasculopathy. Invest. Ophthalmol. Vis. Sci. 2010;51(13):2229.
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To determine the safety and efficacy of intravitreal ranibizumab in the treatment of polypoidal choroidal vasculopathy (PCV).
Phase I/II safety study; prospective, open-label, single-center, non-randomized, uncontrolled, consecutive interventional case series. Enrolled patients were >35 years old and displayed exudative, active PCV. PCV was defined as choroidal neovascularization that displayed occult characteristics on fluorescein angiography and polypoidal interconnecting vascular channels with saccular dilatations on indocyanine green angiography and/or fluorescein angiography. Eyes received 3 consecutive, monthly intravitreal ranibizumab injections (0.5 mg or 0.3 mg/0.05 cc) followed by monthly evaluations with the option of additional intravitreal ranibizumab or alternative treatments at the discretion of the investigator. Baseline and follow-up evaluations included medical history, blood pressure, physical examination, best-corrected ETDRS visual acuity (BCVA), intraocular pressure measurement, complete ophthalmologic examination, fundus photography, fluorescein/ICG angiography, and optical coherence tomography (OCT).
Twenty eyes of 19 subjects were enrolled. Subjects included 16 African-Americans (12 female, 4 male) and 3 male Caucasians. The mean age was 63.6 years and the mean follow-up was 18 months. Mean baseline BCVA and OCT thickness were 20/127 (range, 20/16-20/500) and 298 microns (range, 122-607), respectively. Eyes received a mean of 6.7 injections. Compared with baseline, mean BCVA increased by 1.9 lines at 12 months and by 1.5 lines at 24 months. Five of 18 eyes gained ≥3 lines BCVA at 12 months and 3 of 10 eyes did so at 24 months. Mean OCT thickness decreased by 70.0 um at 12 months and by 68.9 um at 24 months. Significant ocular adverse events included cataract progression (n=2), mild vitreous hemorrhage (n=2), and macular hole (n=1). No systemic adverse events attributable to ranibizumab were observed.
The majority of eyes receiving ranibizumab for treatment of PCV experienced improvement in BCVA and OCT thickness.
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