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INTRAVITREAL BEVACIZUMAB (AVASTIN) FOR PERSISTENT NEW VESSELS IN DIABETIC RETINOPATHY (IBEPE STUDY)

JORGE, RODRIGO MD, PhD*; COSTA, ROGÉRIO A. MD, PhD*†; CALUCCI, DANIELA COMT*†; CINTRA, LÉSSIA P. MD*; SCOTT, INGRID U. MD, MPH‡

Retina:
doi: 10.1097/01.iae.0000246884.76018.63
Original Articles
Abstract

Objective: To evaluate the short-term fluorescein angiographic and visual acuity effects of a single intravitreal injection of bevacizumab (Avastin) for the management of persistent new vessels (NV) associated with diabetic retinopathy.

Methods: A prospective, nonrandomized open-label study of diabetic patients with actively leaking NV refractory to laser treatment and best-corrected Early Treatment Diabetic Retinopathy Study visual acuity (BCVA) worse than 20/40. Standardized ophthalmic evaluation was performed at baseline and at weeks 1, 6, and 12 (±1) following intravitreal injection of 1.5 mg of bevacizumab. Main outcome measures include changes in total area of fluorescein leakage from active NV and BCVA.

Results: Fifteen consecutive patients (men, 9 [60%]; women, 6 [40%]) were included and all completed the 12-week follow-up period of the study. The mean ± SD age of participants was 60.08 ± 7.75 years (median, 59.5; range, 49–73 years). At baseline, mean ± standard error of the mean (SEM) NV leakage area was 27.79 ± 6.29 mm2. The mean ± SEM area of active leaking NV decreased significantly to 5.43 ± 2.18 mm2 and 5.50 ± 1.24 mm2 (P < 0.05, Tukey multiple comparisons post-test) at 1 and 12 weeks postinjection, respectively; at week 6 no leakage was observed. The mean ± SEM logMAR (Snellen equivalent) BCVA improved significantly from 0.90 (20/160) ± 0.11 at baseline to 0.76 (20/125+2) ± 0.12, 0.77 (20/125+2) ± 0.11, and 0.77 (20/125+2) ± 0.12 at weeks 1, 6, and 12, respectively (P < 0.05, Tukey multiple comparisons post-test). No major adverse events were observed.

Conclusions: Intravitreal injection of bevacizumab achieved short-term reduction of fluorescein leakage from persistent active NV without loss of vision in patients with diabetic retinopathy. Further studies to investigate the role of anti-VEGF therapy with bevacizumab for the management of diabetic retinopathy refractory to laser treatment are warranted.

In Brief

After one single intravitreal injection of bevacizumab, regression of actively leaking new vessels refractory to laser photocoagulation treatment was demonstrated as early as one week and up to at least three months after treatment. Whether the observed short-terms effects may be sustained with additional injections remains to be determined.

Author Information

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

This work was supported in part by Fundação de Apoio Ensino e Assistência, Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto.

The authors report no conflicts of interest.

Reprint requests: Prof. Dr. Rodrigo Jorge, Departmento de Oftalmologia, FMRP/USP, Avenida Bandeirantes 3900, Ribeirão Preto-SP 14049-900 Brazil; e-mail: rjorge@fmrp.usp.br

© The Ophthalmic Communications Society, Inc.