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JAMA Ophthalmol. 2013 Feb;131(2):139-45.

Ranibizumab for edema of the macula in diabetes study: 3-year outcomes and the need for prolonged frequent treatment.

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  • 1Wilmer Eye Institute, The Johns Hopkins University School of Medicine, 600 N Wolfe St, Baltimore, MD 21287, USA.

Abstract

OBJECTIVE:

To assess the benefit of increased follow-up and treatment with ranibizumab between months 24 and 36 in the Ranibizumab for Edema of the Macula in Diabetes (READ-2) Study.

DESIGN:

Prospective, interventional, multicenter follow-up of a randomized clinical trial.

METHODS:

Patients who agreed to participate between months 24 and 36 (ranibizumab, 28 patients; laser, 22; and ranibizumab + laser, 24) returned monthly and received ranibizumab, 0.5 mg, if foveal thickness (FTH, center subfield thickness) was 250 μm or greater. Main outcome measures were improvement in best-corrected visual acuity (BCVA) and reduction in FTH between months 24 and 36.

RESULTS:

Mean improvement from the baseline BCVA in the ranibizumab group was 10.3 letters at month 36 vs 7.2 letters at month 24 (ΔBCVA letters = 3.1, P = .009), and FTH at month 36 was 282 μm vs 352 μm at month 24 (ΔFTH = 70 μm, P = .006). Changes in BCVA and FTH in the laser group (-1.6 letters and -36 μm, respectively) and the ranibizumab + laser group (+2.0 letters and -24 μm) were not statistically significant. The mean number of ranibizumab injections was significantly greater in the ranibizumab group compared with the laser group (5.4 vs 2.3 injections, P = .008) but not compared with the ranibizumab + laser group (3.3, P = .11).

CONCLUSIONS:

More aggressive treatment with ranibizumab during year 3 resulted in a reduction in mean FTH and improvement in BCVA in the ranibizumab group. More extensive focal/grid laser therapy in the other 2 groups may have reduced the need for more frequent ranibizumab injections to control edema.

APPLICATION TO CLINICAL PRACTICE:

Long-term visual outcomes for treatment of diabetic macular edema with ranibizumab are excellent, but many patients require frequent injections to optimally control edema and maximize vision.

TRIAL REGISTRATION:

clinicaltrials.gov Identifier:NCT00407381

PMID:
23544200
[PubMed - indexed for MEDLINE]
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