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Ranibizumab Dosing Strategies in DME Previously Treated with Bevacizumab
NCT01982435Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2014
- Primary completion
- May 2016
- Countries
- 1
- Sponsor
- Justis Ehlers Lab
- Modality
- Antibody Fragments, Antibody Conjugates, Monoclonal Antibodies
- Drugs
- ranibizumab
- Conditions
- diabetic macular edema (DME)
01
Overview
Phase 2, randomised, open-label trial of ranibizumab in diabetic macular edema (DME) (2 arms), sponsored by Justis Ehlers Lab. Primary endpoints: Number of Participants With Non-severe and Severe Ocular Adverse Events at 12 months and Number of Participants With Non-severe and Severe Non-ocular Adverse Events at 12 months. Started Jun 2014; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Monthly
Monthly intravitreal ranibizumab
Treat-and-Extend
3 loading doses then treat-and-extend
03
Who it enrols
Adult patients with diabetic macular edema previously treated with at least 6 bevacizumab injections in the last 12 months, with persistent foveal-involving edema.
04
Endpoints
Primary
Number of Participants With Non-severe and Severe Ocular Adverse Events
Number of Participants With Non-severe and Severe Non-ocular Adverse Events
Secondary
Mean Change in BCVA
Mean Change in Central Foveal Thickness
Anatomically Dry Eyes by SDOCT
Gain in Vision Greater Than or Equal to 15 Letters
Loss in Vision Greater Than or Equal to 15 Letters
Participants With BCVA at 20/40 or Better
Number of Participants With Angiographic Leakage
Number of Participants With Nonperfusion
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