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A. Chan, S. M. Hariprasad, C. Y. Chung, P. Wong, L. Tuomi; Delayed Responders in the Treatment of Neovascular Age-Related Macular Degeneration (AMD) With Ranibizumab in the MARINA, ANCHOR, PIER and SAILOR Studies. Invest. Ophthalmol. Vis. Sci. 2010;51(13):103.
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To report on the percentage of delayed responders based on visual acuity (VA) outcomes through Month 12 in patients from the MARINA, ANCHOR, PIER, and SAILOR studies of ranibizumab.
Four phase III/IIIb studies evaluated ranibizumab (0.3 mg or 0.5 mg) for neovascular AMD. In MARINA (minimally classic or occult with no classic CNV) and ANCHOR (predominantly classic CNV), monthly intravitreal injections of ranibizumab were compared to sham or PDT, respectively. In PIER, ranibizumab (3 monthly injections followed by quarterly injections) was compared to sham. In SAILOR Cohort 1, ranibizumab was administered in 3 monthly injections followed by criteria-based retreatment (VA or VA and optical coherence tomography criteria) as needed, up to 12 injections maximum. VA outcomes were examined over 12 months. Patients were categorized based on VA change from baseline: (1) early responders who gained ≥15 letters at Month 3, (2) delayed responders who did not gain ≥15 letters at Month 3, but gained ≥15 letters at Month 12
The VA benefit of ranibizumab was evident as early as Month 1 after first treatment. Some patients who did not initially gain ≥15 letters at Month 3, gained ≥15 letters compared with baseline at Month 12 (Table 1).
Following 3 monthly injections, continued monthly dosing (MARINA/ANCHOR) seemed to have a higher percentage of delayed gainers than continued quarterly or PRN dosing (PIER and SAILOR, respectively). However, these cross-study comparisons should be interpreted with caution.
www.clinicaltrials.gov NCT00056836, NCT00061594. NCT00090623, NCT00251459
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