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(Investigative Ophthalmology and Visual Science. 2006;47:4569-4578.)
© 2006 by The Association for Research in Vision and Ophthalmology, Inc.
DOI:  10.1167/iovs.06-0433

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Intravitreal Bevacizumab for Choroidal Neovascularization Caused by AMD (IBeNA Study): Results of a Phase 1 Dose-Escalation Study

Rogério A. Costa,1,2 Rodrigo Jorge,2 Daniela Calucci,1 José A. Cardillo,1 Luiz A. S. Melo, Jr,1 and Ingrid U. Scott3

1From the U.D.A.T. Macular Imaging and Treatment Division, Hospital de Olhos de Araraquara, Araraquara, SP, Brazil; the 2Retina and Vitreous Section, Department of Ophthalmology, School of Medicine of Ribeirão Preto, University of São Paulo, Ribeirão Preto, SP, Brazil; and the 3Departments of Ophthalmology and Health Evaluation Sciences, Penn State College of Medicine, Hershey, Pennsylvania.

PURPOSE. To evaluate the safety of three dose regimens of intravitreal bevacizumab (Avastin; Genentech, Inc., South San Francisco, CA) for the management of choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD).

METHODS. This was a prospective, nonrandomized open-label study of 45 patients with AMD and subfoveal CNV. A standardized ophthalmic evaluation was performed at baseline and at weeks 1, 6, and 12 (±1) after a single intravitreous injection (1.0, 1.5, or 2.0 mg) of bevacizumab. Main outcomes measures include clinical evidence of toxicity and complications. Changes in best corrected visual acuity (BCVA) and lesion characteristics–macular morphology were also evaluated.

RESULTS. The most common adverse events were conjunctival hyperemia and subconjunctival hemorrhage at the injection site. Mean BCVA improved from baseline throughout the study (P < 0.001; ANOVA with Geisser-Greenhouse correction). Compared with baseline, BCVA was improved at week 1 (P = 0.001), week 6 (P < 0.001), and week 12 (P = 0.001; Dunnett test). At week 12, the lesion area and CNV area were stable or decreased in 79.1% (34/43) and in 74.4% (32/43) of patients, respectively, with no deterioration of macular architecture observed in 83.7% (36/43). A dose-related change in BCVA (in Early Treatment Diabetic Retinopathy Study [ETDRS] lines) was observed at week 12 (1.0 mg [+0.3 line]; 1.5 mg [+0.6 line]; and 2.0 mg [+1.0 line]; P = 0.02; nonparametric test for ordered groups).

CONCLUSIONS. A single intravitreal bevacizumab injection was well tolerated and, except for minor transient local adverse events, no other adverse events were observed. In the short-term, treatment was associated with vision stabilization or improvement and no unfavorable neovascular lesion–macular changes in most patients.





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