Abstract
Purpose: :
To investigate the safety and efficacy of intravitreal ranibizumab in the treatment of polypoidal choroidal vasculopathy (PCV).
Methods: :
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 in 1 eye. 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).
Results: :
Twenty eyes of 20 subjects were enrolled. Subjects included 17 African-Americans (12 female, 5 male) and 3 male Caucasians. The mean age was 63.6 years (range, 37-86) and the mean follow-up was 13 months (range, 1-24 months). Mean baseline BCVA and OCT central subfield thickness were 20/127 (range, 20/20-20/500) and 302 microns (range, 122-607), respectively. After the first three ranibizumab injections, mean BCVA was 20/116 (range, 20/20-20/400) and mean OCT thickness was 233 microns (range, 130-378). At last follow-up visit, mean BCVA was 20/79 (range, 20/20-20/400) and mean OCT thickness decreased to 233 microns (range, 135-449). At the last follow-up visit, 13, 7, and 0 eyes demonstrated improved, unchanged, and worsened BCVA, respectively. Complications included macular hole development in 1 eye that had vitreous and subretinal hemorrhage present at enrollment; posterior vitreous detachment with mild vitreous hemorrhage in 1 eye; and cataract progression, requiring cataract extraction, in 2 patients.
Conclusions: :
In a small prospective study, intravitreal ranibizumab was safe and resulted in decreased retinal thickness and improved visual acuity in the majority of eyes with PCV.
Clinical Trial: :
www.clinicaltrials.gov NCT00837330
Keywords: choroid: neovascularization