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Improved visual acuity results similar in two arms of the Read-3 study
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ORLANDO, Fla. — At month 6, improvement in visual acuity and reduction in retinal thickness were similar between two arms of the Read-3 study, according to a presenter here.
Quan Dong Nguyen, MD, reported 6-month and interim 12-month results of the study at Retina Subspecialty Day that preceded the American Academy of Ophthalmology annual meeting.
In the Read-3 study, patients with diabetic macular edema (DME) were randomized 1:1 to receive either 0.5 mg or 2 mg ranibizumab (Lucentis, Genentech). The primary endpoint at 6 months was mean change in BCVA, Dr. Nguyen said.
At month 12, an interim analysis showed no statistically significant difference in visual gain between the two groups, and there was a trend toward fewer injections in the 2-mg group, he said.
Regarding safety, there were more hospitalizations in the 2-mg group, although "the majority were not associated with anti-VEGF therapy," Dr. Nguyen said. Furthermore, "there were no cases of endophthalmitis," he said.
Additional studies are needed to assess safety parameters, and longer monitoring of the index group is needed to determine the utility of higher-dose ranibizumab in patients with DME, Dr. Nguyen said.
The Read-3 study will follow and treat patients through at least month 24.
- Disclosure: Dr. Nguyen's employer, Johns Hopkins University, has received research funding from Genentech.