Elsevier

Ophthalmology

Volume 114, Issue 4, April 2007, Pages 743-750
Ophthalmology

Original Article
Primary Intravitreal Bevacizumab (Avastin) for Diabetic Macular Edema: Results from the Pan-American Collaborative Retina Study Group at 6-Month Follow-up

Presented in part at: American Academy of Ophthalmology joint meeting with the Asia Pacific Academy of Ophthalmology, November 2006, Las Vegas, Nevada.
https://doi.org/10.1016/j.ophtha.2006.12.028Get rights and content

Purpose

To report the 6-month anatomic and best-corrected visual acuity (BCVA) response after primary intravitreal bevacizumab (Avastin) in patients with diabetic macular edema (DME).

Design

Interventional retrospective multicenter study at 6 centers from 6 countries of patients with DME.

Participants

We reviewed the clinical records of 88 consecutive patients (110 eyes) with DME. Seventy-eight eyes of 64 consecutive patients with a minimum follow-up of 6 months and mean age of 59.7±9.3 years were included in this analysis.

Intervention

Patients were treated with at least one intravitreal injection of 1.25 mg or 2.5 mg of bevacizumab and underwent Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA testing, ophthalmoscopic examination, optical coherence tomography (OCT), and fluorescein angiography (FA) at baseline and follow-up visits. Repeated-measures analysis of variance was used to compare mean values.

Main Outcome Measures

Changes in BCVA, OCT, and FA.

Results

Mean follow-up was 6.31±0.81 months (range, 6–9). Sixteen (20.5%) eyes needed a second injection at a mean of 13.8 weeks (range, 4–28), and 6 eyes needed a third injection (7.7%) at a mean of 11.5 weeks (range, 5–20). The mean baseline BCVA was 0.87 (logarithm of the minimum angle of resolution), and the final mean BCVA was 0.6, a difference that was statistically significant (P<0.0001). Final BCVA analysis by subgroups demonstrated that 32 (41.1%) eyes remained stable, 43 (55.1%) improved ≥2 ETDRS lines of BCVA, and 3 (3.8%) decreased ≥2 ETDRS lines of BCVA. Mean central macular thickness at baseline by OCT was 387.0±182.8 μm and decreased to a mean of 275.7±108.3 at end of follow-up (P<0.0001). No ocular or systemic adverse events were observed.

Conclusions

Primary intravitreal bevacizumab at doses of 1.25 to 2.5 mg seem to provide stability or improvement in VA, OCT, and FA in DME at 6 months. Follow-up is still short to make any specific treatment recommendations; however, the results appear promising. Evaluation in a multicenter randomized controlled clinical trial with longer follow-up is needed.

Section snippets

Patients and Methods

We conducted a multicenter retrospective study of eyes with DME treated with off-label intravitreal bevacizumab (Avastin) between September 2005 and August 2006 at 6 institutions in Venezuela, Mexico, Costa Rica, Brazil, Puerto Rico, and Colombia. We reviewed the clinical records of 88 consecutive patients (110 eyes) with DME treated with at least one intravitreal injection of 1.25 mg or 2.5 mg of bevacizumab. Institutional review board/ethics committee approval and patients’ informed consent

Results

Seventy-eight eyes (64 consecutive patients) with a minimum of 6 months’ follow-up were included for analysis. Fifty-one (79.7%) patients were Hispanic and 12 (18.7%) were Caucasian. Our patients had a mean age of 59.7±9.3 years, and 54.7% were male (35 men, 29 women). Patients had a mean follow-up of 6.31±0.81 months (range, 6–9). Forty-four (56.4%) cases had PDR (Table 1). All of these 44 cases had had prior scatter photocoagulation at least 6 months before undergoing bevacizumab intravitreal

Discussion

Diabetic macular edema is a manifestation of diabetic retinopathy that produces loss of central vision. Although several treatment modalities are under investigation, the only demonstrated means to reduce the risk of vision loss from DME are laser photocoagulation, as demonstrated by the ETDRS4; intensive glycemic control, as demonstrated by the Diabetes Control and Complications Trial and the United Kingdom Prospective Diabetes Study; and blood pressure control, as demonstrated by the United

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  • Cited by (0)

    Manuscript no. 2006-1152.

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

    The authors have no financial or proprietary interest in any of the products or techniques mentioned in the article.

    For a complete listing of participating members, see “Appendix.”

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