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S.G. Alexander, B.A. Blodi, M.K. W. Webster, J.A. Elledge, C.J. Hiner, J. Armstrong, C.M. Hurtenbach, B. Zhang; Ranibizumab (LucentisTM) in Subjects With Predominantly Classic CNV: Reading Center Evaluation of Angiographic Eligibility Characteristics and Baseline Fluorescein Angiographic Data . Invest. Ophthalmol. Vis. Sci. 2006;47(13):2207.
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© ARVO (1962-2015); The Authors (2016-present)
To present Reading Center eligibility data and baseline fluorescein angiographic characteristics of a Phase 3 clinical trial to determine the efficacy and safety of intravitreally administered ranibizumab in predominantly classic choroidal neovascularization (CNV) due to age–related macular degeneration (AMD).
In the trial, patients were randomly assigned treatment in a 1:1:1 ratio (0.5 mg of ranibizumab vs. 0.3 mg of ranibizumab vs. verteporfin PDT). Eligibility criteria included: (1) Classic CNV present and greater than or equal to 50% total lesion size, (2) best corrected visual acuity, using ETDRS charts, between 20/40 to 20/320 (Snellen equivalent), (3) absence of prior subfoveal treatment for macular disease. Ocular disease evaluators at the Fundus Photograph Reading Center provided an angiographic eligibility opinion. Morphologic outcomes were evaluated from fluorescein angiograms and color photographs using a modified MPS grading protocol. Recorded abnormalities include area of classic and occult CNV, fibrous tissue, subretinal fluid, subretinal hemorrhage, total lesion area, and fluorescein leakage.
Of the 721 subjects were reviewed for eligibility 66% were found eligible. Subjects were ineligible for reasons including: (1) CNV not underlying the fovea (2) Lesion less than 50% Classic CNV (3) CNV less than 50% of lesion. Baseline data were available on 423 patients enrolled. The Reading Center evaluators classified 374 eyes (88%) as having classic CNV ≥ 50 %, < 90% of the total lesion, and 36 (9%) with classic CNV ≥ 90% of the total lesion. Among the 382 lesions where subretinal fluid could be determined, 94% had subretinal fluid present. Of the 423 enrolled, 100 % had fluorescein leakage, and 66% had associated hemorrhage at baseline. The median lesion size was 1.45 DA (mean= 1.85 DA, SD= 1.46)
For this trial the rate of eligible subjects as reviewed by the Fundus Photograph Reading Center was 66%. Among patients with predominantly Classic CNV enrolled in the study, the majority had classic CNV between ≥50 but <90% of the total lesion size. Patient follow up is continuing towards the planned 24 month study conclusion.
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