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Ranibizumab injections provide improved vision for patients with diabetic retinopathy
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Data from two recent studies suggest that intravitreal ranibizumab provides patients with diabetic macular edema seeking improved vision a well-tolerated treatment option.
A study published in Diabetes Care revealed that mean best corrected visual acuity improved from baseline by 10.3 letters with ranibizumab and declined by 1.4 letters with sham treatment at 1 year (P<.0001).
The year-long, multicenter, sham-controlled, double-masked study compared intravitreal ranibizumab 0.3 mg or 0.5 mg (Lucentis, Genentech; n=51 each) with sham treatment (n=49). Patients were assigned to three monthly injections; after 3 months, treatment could be stopped or reinitiated with an opportunity for rescue laser photocoagulation. Dose-doubling was permitted after 1 month.
Data also showed a mean central retinal thickness reduction of 194.2 mcm with ranibizumab vs. 48.4 mcm with sham (P<.0001), according to phase 2 results of the Ranibizumab in Diabetic Macular Edema (RESOLVE) study. More than 60% of patients assigned to ranibizumab experienced a best corrected visual acuity improvement of 10 letters or more compared with just 18.4% assigned to sham (P<.0001).
Ranibizumab plus laser
Intravitreal ranibizumab in conjunction with prompt or deferred laser treatments was superior to laser treatment alone or in combination with corticosteroid injections, according to a study by Bressler and colleagues published in Ophthalmology.
The researchers randomly assigned 691 patients with type 1 or type 2 diabetes and diabetic macular edema to one of four treatment modalities: sham injections plus prompt (within 1 week) laser treatment; ranibizumab 0.5 mg plus prompt laser treatment; ranibizumab plus deferred laser treatment at 24 weeks or later; or triamcinolone 4 mg plus prompt laser treatment.
Compared with the sham injection/prompt laser treatment group (+3 standard deviation), the average 1-year change in visual acuity score from baseline was better in the ranibizumab injections/prompt laser treatment (+9 SD, P<.001) and ranibizumab injections/deferred laser treatment (+9 SD; P<.001) groups but not in the corticosteroid/prompt laser treatment group(+4; P=.31).
The ranibizumab groups and triamcinolone/prompt laser groups had similar reductions in mean central subfield thickness, and reductions were greater than in the sham injection/prompt laser group.
Visual acuity improvement in a subset of patients with pseudophakic eyes at baseline (n=273) was comparable in the triamcinolone and ranibizumab groups.
Two-year follow-up results of visual acuity outcomes were similar to the 1-year results, according to the researchers.
Safety and future studies
In the Bressler et al study, three eyes (0.8%) in the ranibizumab group had injection-related endophthalmitis. Elevated intraocular pressure and cataract surgery were more frequent in the triamcinolone/prompt laser group.
The more recent Diabetes Care study demonstrated safety data that were consistent with previous studies of intravitreal ranibizumab, according to the researchers.
“These results indicate a treatment breakthrough for saving the vision of people with diabetic macular edema,” Neil M. Bressler, MD, chair of the Diabetic Retinopathy Clinical Research Network and chief of the retina division at the Wilmer Eye Institute, Johns Hopkins University School of Medicine, said in a press release. “Eye injections of ranibizumab with prompt or deferred laser treatment should now be considered for all patients with the characteristics similar to those in [our] clinical trial.”
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