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M. N. Lott, J. Singh, H. Singh, M. Bartoli, D. M. Marcus; Treatment of Polypoidal Choroidal Vasculopathy With Ranibizumab (Lucentis): A Phase I/II Safety Study. Invest. Ophthalmol. Vis. Sci. 2007;48(13):1439. doi: https://doi.org/.
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To determine short-term safety and potential 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 10 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 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).
Six (5 females, 1 male) African Americans (average age = 67; range 48-86) with PCV were enrolled with average follow-up of 2 months (range 1-3 months). Average baseline visual acuity and OCT central subfield thickness was 20/152 (range 20/63-20/500) and 357 microns (range 87-628), respectively. One month after the first ranibizumab injection, average OCT thickness decreased to 290 microns (range 112-462); OCT thickness decreased in all 4 patients with central subfield edema at baseline. At the last follow-up visit, visual acuity improved in 3 eyes (by 4 lines, 3 lines and 2 lines), was unchanged in 2 eyes, and worsened in 1 eye (by 4 lines due to cataract progression). Complications included visually-significant cataract progression in one eye and minimal worsening of preexisting PCV-related vitreous hemorrhage in one eye.
Preliminary, short-term results indicate that 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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