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N. Lemanski, J. Schartman, N. Falk, C. Hartman, P. Beer; Intravitreal Ranibizumab for Treatment of Advanced Macular Dysfunction in Patients With Disciform Fibrosis Due to Exudative Age-Related Macular Degeneration: The SALVAGE Study. Invest. Ophthalmol. Vis. Sci. 2009;50(13):2372.
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An open label,single site,Phase I/II prospective trial to evaluate intravitreal ranibizumab for treatment of advanced macular dysfunction in patients with disciform fibrosis and active leakage due to exudative AMD.
20 patients with active leakage and disciform fibrosis of the central macula are followed for 1 year.Patients receive intravitreal injections of ranibizumab 0.5mg monthly for 3 months, followed by monthly retreatment if benefit is demonstrated at 3, 6, and 9 months(M).Benefit is determined by 10% reduction of scotoma size in any of 3 macular zones measured by MP-1 microperimetry,10% improvement of multifocal ERG (mERG) amplitudes in any of 3 macular zones,or 100 µm improvement in central macular thickness (CMT) by OCT when compared to baseline (BL).Primary outcomes are scotoma size and mERG amplitudes.Secondary outcomes are BCVA measured by ETDRS at 4m and 1m, contrast sensitivity, CNV leakage area measured by FA, VFQ-25 questionnaires, and incidence and severity of adverse effects as measured by subject reporting, eye, and physical exam.
Results are available for 16 patients through M9,and 13 through M12.Mean BCVA was 10.4 letters at BL;15.2 at M3; 18.2 at M6; 19.9 at M9 and 19.9 at M12.VA improvement over BL was detected in 93% of patients at M3,6 and 9, and in 100% at M12. Mean CMT was 358µm at BL, and 261, 203, 235 and 230µm at M3, 6, 9 and 12 respectively.Mean MP-1 values at BL were 0.4, 3.5, and 4.9 in central, paracentral, and peripheral zones respectively; 0.6, 2.9, and 5.4 at M3; 0.2, 2.6, 4.4 at M6; 0.5, 3.3 and 5.3 at M9; and 0.6, 2.4 and 5.2 at M12 in the respective zones.Mean mERG values at BL were 2.1, 1.9, and 2.2 in the central, paracentral, and peripheral zones; 0.8, 1.4, 1.8 at M3; 1.3, 1.3, 1.7 at M6; 0.6, 0.9, 1.3 at M9;and 0.5, 0.9, 0.9 at M12 in respective zones.One patient reported leg pain and 1 developed iritis(1 injection held, additional injections tolerated without complication).Four patients withdrew due to transportation reasons.Interim VFQ25 data follows BCVA trends;8/13 patients self reported vision improvement,1/13 reported worsening and 4/13 reported no change.
Interim data suggests that sequential ranibizumab intravitreal injections are well-tolerated and may improve VA and macular thickness as measured by OCT in patients with disciform fibrosis and advanced VA loss due to chronic AMD.Data showing a possible improvement in physiologic scotoma size as measured by MP-1 and mERG are inconclusive at this point.Interim VFQ25 data indicates improved quality of life.
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