Status:
COMPLETED
An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Choroidal Neovascularization
Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The pupose of this study is to evaluate the safety and the efficacy of ranibizumab in rare VEGF driven ocular diseases.
Eligibility Criteria
Inclusion
- Active choroidal neovascularization (CNV)
- Active macular edema (ME)
- Rubeosis iridis/neovascular glaucoma.
- Proliferative diabetic retinopathy requiring vitrectomy.
Exclusion
- wet Age-related macular degeneration
- pathologic myopia
- pseudoxanthoma elasticum
- diabetic macular edema
- retinal vein occlusion
- \< 18 years of age
- History of hypersensitivity to ranibizumab
- Use of any systemic anti-angiogenic drugs 3 months before inclusion
- Women of child-bearing potential and Pregnant or nursing (lactating) women.
- Active or suspected ocular infection
Key Trial Info
Start Date :
September 26 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2016
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT01908816
Start Date
September 26 2013
End Date
January 8 2016
Last Update
August 12 2019
Active Locations (39)
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1
Novartis Investigative Site
Bobigny, Seine Saint Denis, France, 93009
2
Novartis Investigative Site
Amiens, France, 80054
3
Novartis Investigative Site
Angers, France, 49044
4
Novartis Investigative Site
Bordeaux, France, 33000