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Henry L. Hudson, RADICAL Study Group; Radical: 24-month Results Of A Phase II Exploratory Randomized Clinical Trial Of Reduced-fluence vPDT-anti-VEGF-dexamethasone In AMD. Invest. Ophthalmol. Vis. Sci. 2011;52(14):3527.
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To determine if combined therapy with reduced-fluence vPDT followed by ranibizumab and dexamethasone reduces retreatment rates compared with ranibizumab monotherapy in subjects with CNV secondary to AMD while maintaining similar vision outcomes and acceptable safety.
Subjects were randomized to 1 of 4 treatment groups: 1) quarter-fluence triple therapy (vPDT 15 J/cm2+ranibizumab 0.5 mg + dexamethasone 0.5 mg; 2) half-fluence triple therapy (vPDT 25 J/cm2 + ranibizumab + dexamethasone); 3) half-fluence vPDT + ranibizumab; or 4) ranibizumab monotherapy. Inclusion criteria were ≥ 50 years, subfoveal choroidal neovascularization from AMD, naïve to treatment, visual acuity (VA) letter score 73-25 (approximate Snellen equivalent of 20/40 - 20/320), and lesion ≤ 5400 microns. Combination groups had 1 mandatory treatment; ranibizumab monotherapy had 3. Central retinal thickness and fluorescein angiography determined retreatment after mandatory treatment.
162 subjects were enrolled. Through Month 24, the cumulative number of combination retreatments was 5.9 (P=.03), 4.3 (P<.001), 5.9 (P=.02), and 8.7 (P value comparing ranibizumab monotherapy) in groups 1, 2, 3, and 4, respectively. Month 24 VA letter score change from baseline (95% confidence interval) was -0.2 (-5.7 to +5.4), +1.1 (-4.3 to +6.4), -0.3 (-6.2 to +5.6), and +4.4 (-1.5 to +10.2), respectively. In the combination groups 5 subjects had serious ocular events considered associated with treatment (increased intraocular pressure, retinal tear, decreased vision, vitreous hemorrhage and retinal/vitreous detachment).
Combination groups had fewer retreatment visits. The triple therapy half-fluence group (group 2) had half the number of retreatment visits required of the ranibizumab monotherapy group. In the second year it was one third. Mean VA change from baseline was not statistically different among the treatment groups, although the sample sizes were insufficient to draw definitive conclusions whether visual acuity outcomes were better or worse in any of the combination groups compared with the ranibizumab monotherapy group. In the second year, overall AE rates remain similar among groups with no new safety concerns.
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