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0.5 mg ranibizumab PRN for diabetic macular edema- long-term open-label extension of the phase III RIDE and RISE trials

Session Details

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        

Abstract Details

Purpose:

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).

Setting:

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.

Methods:

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).

Results:

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.

Conclusions:

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.

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