Patients with DME achieved better long-term visual outcomes when treated with ranibizumab (Lucentis, Genentech) and focal/grid laser combination therapy than with ranibizumab or laser alone, according to the results of the phase 2 READ-2 study published in Ophthalmology.1 Combining the 2 treatments also reduced the frequency of ranibizumab injections needed to control DME, the study authors said.
READ-2 was a 24-month prospective, randomized, interventional multicenter trial in patients (n=126) with DME. The purpose of the study was to determine if ranibizumab was a superior treatment to focal/grid laser photocoagulation or a combination of both in patients with DME.
Patients were randomized 1:1:1 to receive 0.5 mg ranibizumab at baseline and months 1, 3, and 5 (group 1); focal/grid laser photocoagulation at baseline and month 3 if needed (group 2); or a combination of 0.5 mg ranibizumab and focal/grid laser photocoagulation at baseline and month 3 (group 3).
At the 6-month primary endpoint, the mean gain in best corrected visual acuity (BCVA) was significantly greater in group 1 (+7.24 letters) than in group 2 (-0.43 letters) or group 3 (+3.8 letters). For patients with data available at 6 months, a gain of three lines or more occurred in eight of 37 (22%) in group 1 compared with 0 of 38 (0%) in group 2 and three of 40 (8%) in group 3. Excess foveal thickness (FTH) was reduced by 50%, 33%, and 45% in groups 1, 2, and 3, respectively.
For the remaining 18 months, patients in group 1 were evaluated every 2 months and were eligible to receive 0.5 mg ranibizumab if FTH was 250 μm or more. Patients in group 2 were evaluated every 2 months, and if FTH was 250 μm or more, they could receive focal or grid laser treatment or 0.5 mg of ranibizumab. Patients in group 3 were evaluated every 3 months, and if FTH was 250 μm or more, they could receive 0.5 mg ranibizumab followed by focal/grid laser treatment or ranibizumab alone.
At month 24, the mean gain in BCVA in group 1 was 7.7 letters. Patients in group 2, who were originally assigned to the laser group, were predominantly treated with ranibizumab for persistent or recurrent DME between 6 and 24 months; at month 24, they showed a gain of 5.1 letters. Patients in group 3 gained an average of 6.8 letters. The percentage of patients who gained three lines or more of BCVA between baseline and month 24 was 24%, 18%, and 26% in groups 1, 2, and 3, respectively, and the percentage of patients with FTH of 250 μm or less was 36%, 47%, and 68%, respectively.
The visual outcomes at month 24 were not significantly different in groups 2 and 3 from those in group 1, whereas anatomic outcomes were better, with fewer injections of ranibizumab during year 2. The additional focal/grid laser treatment in groups 2 and 3 helped reduce persistent or recurrent DME during months 6 to 24 and the frequency of injections needed, the study authors concluded.
The READ-3 study will investigate if a higher dose of ranibizumab (2.0 mg) is more effective than the standard dose (0.5 mg) in improving vision and decreasing retinal thickness; it will also evaluate if higher doses can reduce the frequency of subsequent treatments for DME.
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