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[FP-SA-53] Diabetic Retinopathy
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Day
Apr 05 (Sat)
Time
15:30 - 17:00
Room
Room 23 - Imperial Hotel 3F Fuji
Topic
Retina - Medical
Chair/Coordinator
Chair)Ian Pearce、Chair)Masahito Ohji
 
 
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FP-SA-53-8

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

【Speaker】
Andreas Lauer
【Author】
Andreas Lauer The Diabetic Retinopathy Clinical Research Network


Objective/Purpose
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.

Materials/Patients
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.

Methods
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 ]
No

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