A 2 year randomized, single-masked, multicenter, controlled phase IIIb trial assessing the Efficacy and safety of 0.5 mg ranibizumab in two “treat and extend” treatment algorithms vs. 0.5 mg ranibizumab as needed in patients with macular edema and visual Impairment secondary to diabetes mellitus
- Registry ID
- EUCTR2010-019795-74
- Source registry
- EUCTR
- Status
- Completed
- Phase
- PHASE3
- Sponsor
- Novartis Pharma Services AG
- Start date
- 2010-08-04
- Completion date
- 2013-04-17
- Last update
- 2026-08-16
Conditions
- Edema Macular Diabético (EDM) // Diabetic Macular Edema (DME)
- Diabetic Macular Edema (DME)
Summary
To demonstrate stepwise that the mean average change from baseline in BCVA over a 12-month treatment period obtained with either a 0.5 mg ranibizumab “Treat and Extend” (TE) dosing regimen with adjunctive laser, and/or with 0.5 mg ranibizumab TE dosing regimen alone is non-inferior to 0.5 mg ranibizumab alone given PRN in patients with visual impairment due to DME and – if successful in the first step – to superiority. The condition for the interpretation of these results is the assessment of the extent to which the TE dosing regimens could be maintained during the study duration.
Locations
- , , Portugal
- , , Poland
- , , Spain
- , , Hungary
- , , Belgium
- , , Czechia
- , , Greece
- , , Italy
- , , France
- , , Ireland
- , , UK
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