Duration 5min, Q&A 3min
Effect of Repeated Injections of Ranibizumab on Risk of Sustained IOP Elevation or Initiation of Ocular Anti-Hypertensive Treatment in Eyes with Center-Involved Diabetic Macular Edema
This study assesses whether there is an increased risk of persistent intraocular pressure (IOP) elevation in eyes with diabetic macular edema (DME) receiving repeated ranibizumab injections through 1 year compared with eyes receiving focal/grid laser.
In a phase III clinical trial conducted by the Diabetic Retinopathy Clinical Research Network (DRCR.net), eyes with baseline DME and IOP ≦ 24 mmHg were randomly assigned to sham+prompt laser (N = 260) and ranibizumab+prompt or deferred laser (N = 322). All eyes were assessed every 4 weeks for need for repeat injection.
Pre-dilation IOP was obtained at each visit. Cumulative probability of persistent elevation of IOP (defined as IOP of ≧22 mmHg and an increase ≧6 mmHg from baseline at 2 consecutive visits) or initiation of ocular anti-hypertensive medication or procedure during the first year of follow-up was calculated using the Kaplan-Meier method. Data from eyes that received intravitreal corticosteroid injections (N=9 and 1 in sham and ranibizumab groups respectively) were censored at the time of switching.
Results and Conclusion
Mean baseline IOP was 16±3 mmHg in both groups. Four and 5% of sham and ranibizumab group eyes, respectively, had a baseline IOP of 22-24 mmHg. In each group, 3% had a history of glaucoma or used IOP-lowering medicine prior to randomization. On average, 8 intravitreal injections were performed within year 1 in the ranibizumab group. The cumulative probability of persistent IOP elevation or initiation of ocular anti-hypertensive medications or procedure by 1 year was 4% in the sham group versus 7% in the ranibizumab group (hazard ratio = 0.62, 95% CI: 0.32 to 1.19, P = 0.21). The cumulative probability of persistent IOP elevation by 1 year was 2% in the sham group versus 4% in the ranibizumab group. Three and 2% of eyes in the sham and ranibizumab groups, respectively, received IOP-lowering medication without meeting criteria for persistent IOP elevation. Only one eye (in the sham group) underwent glaucoma procedure through 1 year. Median IOP at 1 year was similar in the two groups when stratified by number of injections.There is not a large clinically relevant difference in the one-year risk of sustained IOP elevation or initiation of IOP-lowering treatment in eyes receiving repeated intravitreal injections for DME as compared with eyes receiving sham. However, the number of IOP-related events was small in both groups thus a small difference cannot be ruled out.
[ Keyword ]
Ranibizumab / Diabetic macular edema / Diabetic retinopathy / Intraocular pressure / Injection
[ Conflict of Interest ]