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N. Lemanski, J. P. Schartman, N. S. Falk, C. Hartman, P. M. Beer; Intravitreal Ranibizumab for the Treatment of Disciform Age-Related Macular Degeneration: The SALVAGE Study. Invest. Ophthalmol. Vis. Sci. 2008;49(13):326.
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Interim data for the SALVAGE Study, an open-label, Phase I/II, single site, prospective trial investigating the efficacy of sequential intravitreal injections of ranibizumab in patients with disciform age-related macular degeneration.
The study will enroll 20 patients for a 12-month duration. Patients receive intravitreal injections of ranibizumab 0.5 mg monthly for three months, followed by additional injection series if a treatment benefit is obtained at 3, 6 and 9 month decision points. Primary outcomes are scotoma size and multifocal ERG amplitudes. Secondary outcomes are BCVA, central macular thickness, contrast sensitivity, CNV leakage area and VFQ-25 questionnaires.
17 patients have been enrolled to date. All had disciform fibrosis involving the central macula and with active leakage. 14 patients reached the 3-month decision point and 8 patients reached the 6-month one. The mean presenting visual acuity score was 11 letters (equ. 20/600, range 0 to 20). Mean visual acuity score at 3-months was 15.1 (equ. 20/500, range 1 to 28) and at 6 months was 17.25 (equ. 20/480, range 7 to 35). Visual acuity improvement >0 letters was detected in 12/14 patients at 3-months and 8/8 patients at 6-months. The mean presenting OCT central macular thickness was 402 (range 183 to 1034) microns. The mean central macular thickness was 264 and 202 at 3 months and 6 months respectively. The mean presenting MP-1 microperimetry attenuation was 0.36, 2.54, and 4.3 dB in the central, pericentral, and paracentral macular zones respectively. The mean MP-1 values were 0.4, 2.31, and 5.3 at 3-months; and 0, 1.66, 4.77 at 6-months in the respective zones. The mean presenting multifocal ERG amplitudes were 1.77, 1.89, and 2.07 µV in the central, pericentral, and paracentral macular zones respectively. The mean mfERG values were 0.94, 1.47, 1.85 at 3-months; and 2.26, 1.91, 2.58 at 6-months in the respective zones. A treatment benefit was found for 13/14 patients at 3-months and 8/8 patients at 6-months. 2 patients withdrew from the study due to transportation difficulties. Adverse events occurred in 2 patients; one unrelated (chronic leg pain) and one possibly related (iritis).
Interim data suggests that treatment with sequential ranibizumab intravitreal injections may improve visual acuity and reduce macular thickness in patients with disciform macular degeneration. Other outcome measures are inconclusive at this point.
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