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B. R. Baumrind, H. Singh, M. N. Lott, J. Singh, D. M. Marcus; Intravitreal Ranibizumab (Lucentis) for PolypoidalChoroidal Vasculopathy. Invest. Ophthalmol. Vis. Sci. 2008;49(13):299. doi: https://doi.org/.
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To determine safety and efficacy of intravitreal ranibizumab for polypoidal choroidal vasculopathy (PCV).
Phase I/II safety study, open-label, single-center, non-randomized, uncontrolled, consecutive case-series. Prospective, random sample of 13 consecutive adults, age >35 years, with exudative, active PCV defined as CNV with occult characteristics on fluorescein angiography with saccular dilations and polypoidal interconnecting vascular channels on indocyanine green angiography and/or fluorescein angiography. Eyes received 3 consecutive monthly intravitreal ranibizumab injections (0.5mg or 0.3 mg/0.05 cc) followed by monthly evaluations with options of intravitreal ranibizumab or other therapies at the discretion of the investigator. Baseline and monthly evaluations included medical history, blood pressure, physical exam, ETDRS chart best-corrected visual acuity, intraocular pressure measurement, and complete ophthalmologic exam, fluorescein/ICG angiography, fundus photography, and optical coherence tomography (OCT).
Thirteen subjects were enrolled and included 11 African Americans (9 female, 2 male) and 2 Caucasians (both male) with 9.7 month average follow-up (range 1-17 months). Average baseline visual acuity (VA) and OCT central subfield thickness was 20/154 (range 20/25-20/500) and 334 microns (range 122-607), respectively. After the first two ranizibumab injections, average VA was 20/141 (range20/25-20/400) and average OCT thickness decreased to 227 (range 132-383). At last follow-up visit, average VA average was 20/108 (range 20-400) and average OCT thickness 255 (range 132-438). At the last followup visit, 6, 3, and 4 eyes demonstrated improved, unchanged, and worsened VA, respectively. Eight of 9 eyes with baseline OCT thickness >200 um demonstrated decreased thickness after ranibizumab. Complications included macular hole development in 1 patient with vitreous and subretinal hemorrhage present at enrollment and cataract progression requiring cataract extraction in 1 patient.
Intravitreal ranibizumab is safe and results in decreased retinal thickness and improved visual acuity in a significant proportion of eyes with PCV.
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