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Anne E. Fung, Brandon G. Busbee, John W. Kitchens, Jan Kristine Bayabo, Richard E. Shaw; Visual Acuity and Injection Frequency Results of 2mg Ranibizumab for Pigment Epithelial Detachments Refractory to Conventional Dosing in the HiPED study. Invest. Ophthalmol. Vis. Sci. 2012;53(14):4180.
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Wet age-related macular degeneration (AMD) with fibrovascular pigment epithelial detachments (PED) that remain after 6 consecutive injections of standard dose ranibizumab and/or bevacizumab are a challenging subtype to manage. The High dose ranibizumab for PED (HiPED) Study was designed to evaluate changes in visual acuity after dose escalation to 2mg ranibizumab comparing two treatment algorithms. We hypothesized that the higher dose would control the disease more effectively as indicated by improvements in visual acuity.
The HiPED protocol was granted approval by the CPMC IRB and conducted in compliance with the Declaration of Helsinki. Consented subjects were enrolled into this randomized, prospective open-label, multi-center, investigator sponsored study for 24 months. Subjects were randomized into two treatment groups: Group 1 received 2mg injections monthly, and Group 2 received 2mg for 3 months followed by as needed (PRN) injections for presence of any macular fluid or PED on SD-OCT. At each visit, modified ETDRS protocol visual acuity, dilated fundus exam, and SD-OCT were performed. ETDRS protocol refractions were conducted at baseline, Months 6, 12, 18 and 24. Results from the previous refraction were used in the intervals. Fluorescein angiography was captured at baseline, Months 6, 12 and 24. Changes in ETDRS letters from baseline to Month 6, and baseline to Month 12 were evaluated. Paired-t-test analysis was conducted using SPSS (version x.x).
37 patients were enrolled: 19 in Group 1, 18 in Group 2. Patients have completed 6 months (n=31), and 12 months (n=13). Mean visual acuity (VA) at entry was 65 letters (range 44-77 Snellen eq 20/32-20/100). VA improved at 6 months by 4.5 letters (n=31, p= 0.003), and at 12 months by 8 letters (n=13, p=0.009). Only 2 of 15 Group 2 subjects did not require one PRN injection. Of 13 subjects completing one year (8 in Group 1 and 5 in Group 2), all required an injection monthly.
Nearly all subjects with wet AMD and fibrovascular PED refractory to at least 6 months of previous standard therapy required monthly 2mg ranibizumab injections as guided by SD-OCT. Mean visual acuity improved by 4.5 letters at 6 months, and 8 letters by 12 months. Continued monthly injections were required but did result in improved vision.
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