Status:
COMPLETED
Assess the Efficacy/Safety of Intravitreal Ranibizumab in Patients With Vision Loss Due to Choroidal Neovascularization.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Choroidal Neovascularization (CNV)
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
This study was conducted to evaluate the efficacy and safety of 0.5 mg ranibizumab in adult and adolescent patients with visual impairment due to choridal neovascularization (CNV).
Eligibility Criteria
Inclusion
- Key
- Diagnosis of active CNV secondary to any causes with the CNV or its sequelae affecting the fovea;
- BCVA must be between ≥ 24 and ≤ 83 letters in the study eye;
- Visual loss in the study eye should mainly be due to the presence of any eligible types of CNV;
- Key
Exclusion
- Women of child-bearing potential;
- Active malignancies;
- History of stroke less than 6 months prior to screening;
- Uncontrolled systemic inflammation or infection;
- Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation;
- CNV- conditions with a high likelihood of spontaneous resolution;
- History of intravitreal treatment with steroids;
- History of laser photocoagulation;
- History of intraocular treatment with any anti-angiogenic drugs.
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT01840410
Start Date
September 1 2013
End Date
November 1 2015
Last Update
August 26 2016
Active Locations (59)
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1
Novartis Investigative Site
Sydney, New South Wales, Australia, 2000
2
Novartis Investigative Site
Adelaide, South Australia, Australia, 5000
3
Novartis Investigative Site
South Launceston, Tasmania, Australia, 7249
4
Novartis Investigative Site
Montreal, Quebec, Canada, H1T 2M4