Efficacy and Safety of Ranibizumab (LUCENTIS®) for the Treatment of Choroidal Neovascularization Not Due to Age-Related Macular Degeneration: 6-Month Data From a Randomized Clinical Trial

Abstract

Purpose: : To evaluate the efficacy and safety of ranibizumab for the treatment of choroidal neovascularization (CNV) secondary to causes other than age-related macular degeneration (AMD).

Methods: : In this phase 1 multicenter clinical trial, patients were randomized 1:1 to 0.5 mg intravitreal ranibizumab as monthly injections or as 3 monthly injections with further treatment as needed (PRN). All subjects were diagnosed with CNV not related to AMD by fluorescein angiography (FA), stereo fundus photography, and optical coherence tomography (OCT). Patients receiving 3 monthly injections were re-treated if the study eye showed evidence of a >5 ETDRS letter decrease in visual acuity (VA), leakage on FA, intraretinal/subretinal fluid on OCT, or central retinal thickness (CRT) ≥225 µm on OCT at follow-up examinations. Outcome measures included mean change in VA, mean changes in CRT, and the incidence of serious ocular and nonocular adverse events (AEs).

Results: : Thirty patients were enrolled. Of 23 evaluable patients at 6-month follow-up, mean change (± SEM) in VA from baseline was 25.8 ± 4.1 letters and mean change (± SEM) in CRT was –179.0 ± 33.5 µm. Among 11 patients receiving monthly injections (average number of injections 6.6 [range 5-7]), mean change in VA was 24.9 ± 6.6 letters and mean change in CRT was –109.5 ± 19.9 µm. Among 12 patients receiving 3 monthly injections followed by PRN dosing (average number of injections 4.4 [range 3-6]), mean change in VA was 26.6 ± 5.2 letters and mean change in CRT was –223.2 ± 55.9 µm. No serious drug-related AEs were reported.

Conclusions: : These preliminary results suggest that ranibizumab is safe and may improve vision and anatomical outcomes in patients with CNV secondary to causes other than AMD. No differences in outcomes were noted at 6 months between the monthly and the PRN groups. Larger randomized studies are warranted.

Clinical Trial: : www.clinicaltrials.gov NCT00395551

Keywords: choroid: neovascularization • vascular endothelial growth factor