Abstract
Purpose: :
To investigate the efficacy and safety of intravitreal ranibizumab injections for patients with a vascularized pigment epithelial detachment (vPED) due to submacular neovascular AMD randomized to monthly injections versus as needed injections.
Methods: :
This prospective pilot Investigator Sponsored Trial has enrolled 10 eyes in 10 patients since December 2008 to December 2009. Five patients randomized to Regimen 1 received mandatory monthly intravitreal injections of 0.5 mg of ranibizumab for 12 months, versus 5 patients in Regimen 2 who received monthly loading injections of the same for 4 months followed by as needed monthly injections based on OCT and vision criteria for up to 12 months. Baseline and follow-up best corrected standardized ETDRS VA (letters scores [LS], LOGMAR units), fundus and fluorescein photography, biomicroscopy, and OCT were performed according to a pre-determined schedule.
Results: :
There were 9 females and 1 male. Mean age was 83.7 (range 74-94). Mean follow-up time was 9.9 months (range: 6-12.2 months). Mean pre- and post treatment best-corrected VA were 53.2± 12.7 LS (20/100) and 50.7±23.9 LS (20/93), (P=0.7 and 0.83, Paired-T-test) respectively. Mean pre-and post-treatment vPED heights were 361.9± 179.6 microns and 289.7± 133.7 microns (P=0.09 , Paired T-test). Mean pre- and post-treatment greatest linear diameter (GLD) of vPED were 4173.6 ± 410.9 microns and 3616.7±948.7 microns (P =0.036, Paired T-test). The mean pre and post-treatment surface area (SA) were 10.4 ± 2.8 mm2 and 8.6 ±4.8 mm2 (P=0.06, Paired T-test). There were statistical differences in the severity of the pre and post-treatment subretinal fluid and cystoid macular edema (P =0.02 and 0.01 respectively, Wilconxon Signed Ranks Test), but not cataract status (P=0.32, 0.18, 0.66 Wilcoxon Signed Ranks Test). Serious ocular adverse events included only substantial cataract progression in 1 eye, and RPE tear in 1 eye. There were no differences in the results between Regimens 1 and 2 (T-test, Mann Whitney test).
Conclusions: :
Conventional dosage of intravitreal ranibizumab consistently reduced the size of the vPED, and the amount of subretinal fluid and cystoid macular edema associated with the vPED. There was also a trend toward decreased vPED height associated with ranibizumab treatment and an acceptable safety profile. The results of mandatory monthly injections and as needed injections were comparable.
Clinical Trial: :
www.clinicaltrials.gov NCT00749021
Keywords: age-related macular degeneration • retinal pigment epithelium • choroid: neovascularization