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Anti-VEGF shows good results in treating DME at 12 months

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ATLANTA — At 12 months follow-up, ranibizumab was shown safe and effective in treating diabetic macular edema, a surgeon said here.

Pascale G. Massin, MD, presented results from the phase 2 RESOLVE study. Image: Altersitz K, OSN

"Results from the phase 2 RESOLVE study indicate that DME responds to treatment with intravitreal ranibizumab. Efficacy in ranibizumab-treated patients showed clinical and statistical superiority vs. sham treatment in terms of mean average change in best corrected visual acuity and central retina thickness," Pascale G. Massin, MD, said at the American Academy of Ophthalmology meeting.

The multicenter, randomized, double-masked study looked at 151 patients randomized to one of two doses of Lucentis (ranibizumab, Genentech) or sham treatment; 42 patients were analyzed at 6 months and 109 were analyzed at 12 months. Investigators had the opportunity at 1 month to double either of the ranibizumab doses, with the 0.3 mg dose going to 0.6 mg and the 0.5 mg dose going to 1 mg.

"Retinal VEGF levels may be considerably higher in the retina and vitreous of patients with DME than in patients with neovascular AMD," Dr. Massin said in her presentation, which won Best Paper of the retina/vitreous original papers session.

Mean BCVA in the 102 patients treated with either dose increased by a mean of 7.6 lines while mean central retinal thickness decreased by more than 150 µm.

I think the evidence has suggested that VEGF levels are higher in DME than compared to AMD or others. I think that there is anecdotal evidence suggesting that ranibizumab may be superior to bevacizumab in diabetic macular edema, but maybe not so much in some other things and so it does suggest that higher levels of VEGF-blocking activity would be something certainly worth testing. The results of this study are quite good. … The VEGF levels at baseline do predict outcome to some extent in patients with vein occlusion and one would anticipate that would probably be similar in diabetic macular edema.

Peter A. Campochiaro, MD
Johns Hopkins Hospital School of Medicine, Baltimore, U.S.A.