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M.K. Webster, B.A. Blodi, S. Glaeser Alexander, J.A. Elledge, C. Hiner, C.H. Hurtenbach, J.A. Armstrong, B. Zhang; Ranibizumab (LucentisTM) in Subjects With Minimally Classic or Occult CNV (MARINA): Reading Center Evaluation of Angiographic Eligibility Characteristics and Baseline Fluorescein Angiographic Data . Invest. Ophthalmol. Vis. Sci. 2006;47(13):2206.
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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 III clinical trial to determine the efficacy and safety of intravitreally administered ranibizumab in occult and minimally classic choroidal neovascularization (CNV) due to age–related macular degeneration (AMD).
In the MARINA trial, patients were randomly assigned treatment in a 1:1:1 ratio (0.5 mg of ranibizumab vs. 0.3 mg of ranibizumab vs. sham). Eligibility criteria included: (1) subfoveal CNV (either occult or minimally classic lesion) with a total lesion size of ≤ 12 disc areas, (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. The primary efficacy outcome is change from baseline VA at the 12 month visit. 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 1032 subjects reviewed for eligibility, 79 % (820) were found eligible. Of those found ineligible, reasons included: (1) CNV not underlying the fovea, (2) CNV < 50% of the total lesion, (3) Classic CNV > 50% of the total lesion. Baseline data were available on 716 patients enrolled. The Reading Center evaluators classified 451subjects (63 %) as having occult CNV with no classic, and 264 eyes (37 %) as having minimally classic CNV (159 with classic CNV ≤ 10 % of the total lesion, 105 with classic CNV > 10% of the total lesion). Among the 716 lesions, 95 % had fluorescein leakage, and 54 % had associated hemorrhage at baseline. Among the 656 lesions where subretinal fluid could be determined, 79% had subretinal fluid present. The median lesion size was 3.93 DA (mean= 4.38 DA, SD= 2.55).
Among patients with occult CNV enrolled in the MARINA Study, 63 % had occult with no classic CNV in the study eye. Patient follow up is continuing towards the planned 24 month study conclusion.
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