Primary Intravitreal Bevacizumab for Diffuse Diabetic Macular Edema: The Pan-American Collaborative Retina Study Group at 24 Months

Presented in part at: American Academy of Ophthalmology Retina Subspecialty Day, November 2008, Atlanta, Georgia.

Received 3 December 2008; received in revised form 20 February 2009; accepted 11 March 2009. published online 22 June 2009.

Purpose

To report the 24-month anatomic and Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) response after primary intravitreal bevacizumab (Avastin; Genentech, Inc., San Francisco, CA; 1.25 or 2.5 mg) in patients with diffuse diabetic macular edema (DDME). In addition, a comparison of the 2 different doses of intravitreal bevacizumab (IVB) used is presented.

Design

Retrospective, multicenter, interventional, comparative case series.

Participants

The clinical records of 115 consecutive patients (139 eyes) with DDME at 11 centers from 8 countries were reviewed.

Methods

Patients were treated with at least 1 intravitreal injection of 1.25 or 2.5 mg of bevacizumab. All patients were followed up for 24 months. Patients underwent ETDRS BCVA testing, ophthalmoscopic examination, optical coherence tomography (OCT), and fluorescein angiography (FA) at the baseline, 1-, 3-, 6-, 12-, and 24-month visits.

Main Outcome Measures

Changes in BCVA and OCT results.

Results

The mean age of the patients was 59.4±11.1 years. The mean number of IVB injections per eye was 5.8 (range, 1–15 injections). In the 1.25-mg group at 1 month, BCVA improved from 20/150 (0.88 logarithm of the minimum angle of resolution [logMAR] units) to 20/107, 0.76 logMAR units (P<0.0001). The mean BCVA at 24 months was 20/75 (0.57 logMAR units; P<0.0001). Similar BCVA changes were observed in the 2.5-mg group: at 1 month, BCVA improved from 20/168 (0.92 logMAR units) to 20/118 (0.78 logMAR units; P = 0.02). The mean BCVA at 24 months was 20/114 (0.76 logMAR units; P<0.0001). In the 1.25-mg group, the mean central macular thickness (CMT) decreased from 466.5±145.2 μm at baseline to 332.2±129.6 μm at 1 month and 286.6±81.5 μm at 24 months (P<0.0001). Similar results were obtained in the 2.5-mg group.

Conclusions

Primary IVB at doses of 1.25 to 2.5 mg seem to provide stability or improvement in BCVA, OCT, and FA in DDME at 24 months. The results show no evident difference between IVB at doses of 1.25 or 2.5 mg.

Financial Disclosure(s)

The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Available online: June 21, 2009.

1 Retina and Vitreous Service, Clinica Oftalmológica Centro Caracas, Caracas, Venezuela

2 Instituto Nacional de Investigación en Oftalmología (INIO), Medellin, Colombia

3 Instituto de Cirugia Ocular, San Jose, Costa Rica

4 Instituto da Visão, Departamento de Oftalmologia, Universidade Federal de São Paulo, São Paulo, Brazil

5 OFTALMOS, Universidad de Buenos Aires, Facultad de Medicina, Buenos Aires, Argentina

6 Instituto Docente de Especialidades Oftalmológicas (IDEO), Maracaibo, Venezuela

7 Centro de Oftalmología Bonafonte Barcelona, Spain

8 MACULA D&T Diagnóstico, Tratamiento & Rehabilitación Visual, Lima, Peru

9 Consorcio Hospital, General Universitario de Valencia, Valencia, Spain

10 Fundacion Oftalmologica Nacional, Universidad del Rosario, Bogota, Colombia

Correspondence: J. Fernando Arevalo, MD, FACS, Clinica Oftalmologica Centro Caracas, Edif. Centro Caracas PH-1, Av. Panteon, San Bernardino, Caracas 1010, Venezuela

Manuscript no. 2008-1437.

Group members of PACORES listed in Appendix 1 (available at http://aaojournal.org).

Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Supported in part by the Arevalo-Coutinho Foundation for Research in Ophthalmology, Caracas, Venezuela.

PII: S0161-6420(09)00280-2

doi:10.1016/j.ophtha.2009.03.016

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