Citation: Schmidt-Erturth U, Lang GE, Holz FG, et al. Three year outcomes of individualized ranibizumab treatment in patients with diabetic macular edema. Ophthalmology. 2014; 121 1045-1053.
To evaluate the long-term efficacy and safety during 3 years of individualized ranibizumab treatment in patients with visual impairment due to diabetic macular edema (DME)
Phase 3b, multicenter, 12 month, randomized core study and 24 month open label extension study
36 months (24 months post 12 month core study)
Patients who completed randomized 12-month RESTORE core study
All patients were eligible to receive intravitreal ranibizumab 0.5mg at 1 month intervals until a stable BCVA or BCVA letter score >84 letters was achieved. If patients demonstrated decrease in BCVA due to DME, monthly ranibizumab injections were resumed until stable BCVA was achieved. All patients were eligible to receive PRN laser in accordance with the ETDRS guidelines.
RESULTS (36 months)
- 240 subjects
Visual acuity end-points
- Mean BCVA gain (letters) were maintained at month 36: prior ranibizumab 8±1.1, prior ranibizumab + laser 6.7±1.05. Prior laser improved from 2.3±1.1 in core study, to 6.0±1.0.
- BCVA score >78 letters at month 36: 42.2% prior ranibizumab, 28.9% prior ranibizumab + laser, prior laser 17.6%.
- Central retinal thickness reduction (μm) was maintained at month 12 vs. 36: prior ranibizumab -127.8, -142.1, prior ranibizumab + laser 139.7, –145.9. Prior laser group demonstrated progressive a reduction of -79.4 in CRT, from -63.3 at 12 months
- Mean central retinal thickness (CRT) reduction month 12 (μm): ranibizumab 0.5mg -118.7±115.07, ranibizumab 0.5mg + laser -128.3±114.34, laser -61.3±132.29
- No cases of endophthalmitis were reported
- The most common ocular serious adverse events (SAE) was cataract.
Ranibizumab was effective in improving and maintaining BCVA and CRT. Ranibizumab was well tolerated with no new safety concerns over 3 years