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Ranibizumab in Proliferative Diabetic Retinopathy
NCT01594281Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2012
- Primary completion
- Nov 2016
- Countries
- 1
- Sponsor
- Novartis
- Modality
- Antibody Fragments, Antibody Conjugates, Monoclonal Antibodies
- Drugs
- ranibizumab
- Conditions
- proliferative diabetic retinopathy (PDR)
01
Overview
Phase 2, randomised, open-label trial of ranibizumab in proliferative diabetic retinopathy (PDR) (3 arms), sponsored by Novartis. Primary endpoint: Change From Baseline in Area of Neovascularizations (NVs) at 12 months. Started Dec 2012; status: completed.
02
Design
3 arms- Study design
- RandomizedOpen-label
Ranibizumab mono
Ranibizumab 0.5 mg monthly until stability
PRP mono
Panretinal laser photocoagulation
Ranibizumab+PRP
Ranibizumab 0.5 mg + PRP
03
Who it enrols
Patients with Proliferative Diabetic Retinopathy (PDR) and BCVA >= 20 letters, with Type 1 or Type 2 diabetes. Excludes patients with CSME or PVR.
04
Endpoints
Primary
Change From Baseline in Area of Neovascularizations (NVs)
Secondary
Change From Baseline in Area of Neovascularizations (NVs) at Month 3
Best Corrected Visual Acuity
Percentage of Patients With Change From Baseline in BCVA
Change From Baseline in ETDRS Severity Grade of Diabetic Retinopathy
Change From Baseline in Central Subfield Thickness
Number of Ranibizumab Injections
05
Results
Primary endpoints met
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