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B. G. Busbee, C. C. Awh, P. L. Sonkin, G. S. Gutow; Efficacy and Safety of 1.0mg Ranibizmab for Age-Related Macular Degeneration: Interim Analysis of a Prospective Investigator Sponsored Trial. Invest. Ophthalmol. Vis. Sci. 2009;50(13):2356.
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To assess safety, need for multiple dosing, and efficacy of a higher dose of ranibizumab for naïve, exudative age-related macular degeneration (wet AMD).
An on-going prospective, patient-blinded, single-center, randomized two-year trial comparing 0.5mg or 1.0 mg intravitreal ranibizumab for wet AMD. Following the initial injection, additional injections are given only if ETDRS vision decreases by 5 letters or optical coherence tomography (OCT) demonstrates recurrent fluid. During the first 6 months, subjects are followed bimonthly, after which monthly assessments for the remaining 18 months of the study occur. Outcomes assessed include ocular and systemic safety, visual acuity and OCT outcomes.
Interim analysis at 6 months of 15 subjects demonstrated all subjects gained vision with treatment. Eighty (80%) of subjects gained 15 or more ETDRS letters. At baseline, mean visual acuity was 58 ETDRS letters and increased to 75 ETDRS letters at 6 months (+17 letters). The mean treatment interval was approximately one injection every 2.5 months for the 1.0 mg cohort and every 2 months for the 0.5 mg cohort. With bimonthly follow-up, a trend was noted for patients to decline in vision prior to fluid being detected on OCT. Initial visual acuity analysis also revealed some subjects experienced continued visual gain for many months following their initial injection without retreatment. Only a small percentage of study participants met the criteria for monthly ranibizumab injections with either dose. No serious adverse events occurred during the study period. Updated results of this ongoing prospective clinical trial will be presented including comparisons of the two study groups. The study cohort will have follow-up ranging from 8 to 20 months.
In the first study evaluating a higher dose of ranibizumab for wet AMD, initial analyses suggests 1.0mg ranibizumab had a favorable ocular and systemic safety profile. Subjects had improvement in visual acuity using a purely PRN regimen of 0.5 and 1.0mg ranibizumab with bimonthly follow-up. A higher dose may allow for longer dosing intervals with comparable or better visual acuity results to standard dosing for wet AMD.
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