Overview
Assess the Efficacy/Safety of Intravitreal Ranibizumab in Patients With Vision Loss Due to Choroidal Neovascularization.
Status:
Completed
Completed
Trial end date:
2015-11-01
2015-11-01
Target enrollment:
0
0
Participant gender:
All
All
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).Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Novartis PharmaceuticalsTreatments:
Endothelial Growth Factors
Ranibizumab
Criteria
Key Inclusion Criteria:- 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 Criteria:
- 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.