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C. K. Chan, P. Abraham, A. S. D. Nuthi, K. M. Chan, S. G. Lin; Intravitreal Ranibizumab for Treatment of Vascularized Pigment Epithelial Detachment (vPED) Associated With AMD, a Prospective Pilot Study. Invest. Ophthalmol. Vis. Sci. 2010;51(13):923.
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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.
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.
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).
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.
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