Session Title: FP-14 Vascular Diseases and Diabetic Retinopathy IV
Session Date/Time: Saturday 13/09/2014 | 16:30-18:00
Paper Time: 17:02
Venue: Boulevard F
First Author: : P.Schlottmann ARGENTINA
Co Author(s): : L. Tuomi K. Basu J.S. Ehrlich
To determine if the efficacy and safety achieved with monthly ranibizumab can be maintained with less-than-monthly treatment in patients with diabetic macular edema (DME).
RIDE and RISE were two randomized, double-masked, sham-controlled multicenter phase III studies that evaluated the efficacy and safety of intravitreal ranibizumab compared with sham injections through Month 24. The open-label extension phase began after the 36-month masked phase of the studies, the first 24 months of which were sham controlled.
Month 36 was the final visit for the masked phase of the studies, after which patients could enter the open-label extension phase. All patients participating in the open-label extension received 0.5 mg ranibizumab injections according to predefined re-treatment criteria. Patients received a 0.5 mg ranibizumab intravitreal injection when either of the following criteria were met: Evidence of DME based on OCT evaluation, or worsening of vision by ≥5 ETDRS letters compared to Month 36 (due to DME and not another cause).
The RIDE/RISE extensions provide additional long-term safety and efficacy data on ranibizumab for DME. An additional 2225 injections were administered during the extension phase. Approximately 25% of patients did not require further anti-VEGF therapy based on the pre-defined retreatment criteria, and maintained stable vision and OCT throughout the extension phase. Approximately 75% of patients received criteria-based re-treatment, with an average time to first re-treatment of 2–3 months from Month 36. On average, only 4.5 injections were administered over a follow-up of 14.1 months. Mean BCVA remained stable in patients continuing from all prior treatment groups. Mean BCVA also remained stable in the subsets of patients receiving re-treatment during the extension phase. Patients who did not require re-treatment demonstrated sustained or improved vision. CFT was stable with a trend toward slight increase in all patients. The safety profile of ranibizumab in the open-label extension appeared similar to that observed in the controlled core studies, based on the types of AEs reported.
Overall, VA outcomes were excellent. Vision gains achieved during the core studies with monthly ranibizumab therapy were maintained with a less-than-monthly 0.5 mg ranibizumab dosing regimen. Patients whose ranibizumab treatment was deferred by 2 years (randomized initially to sham) did not achieve the same VA gains as patients who received ranibizumab from baseline.