A 12-month, Randomized, Double-masked, Sham-controlled, Multicenter Study to Evaluate the Efficacy and Safety of 0.5mg Ranibizumab Intravitreal Injections in Patients With Visual Impairment Due to Vascular Endothelial Growth Factor (VEGF) Driven Choroidal Neovascularization.
Overview
- Phase
- Phase 3
- Intervention
- Ranibizumab
- Conditions
- Choroidal Neovascularization (CNV)
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 183
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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).
Investigators
Eligibility Criteria
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;
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.
Arms & Interventions
Ranibizumab
A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
Intervention: Ranibizumab
Sham control
Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
Intervention: Sham control
Outcomes
Primary Outcomes
Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2
Time Frame: Baseline, Month 2
BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. The data were analyzed using mixed model repeated measures (MMRM) which contained scheduled visit, the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate and treatment group by visit and visit by centered baseline BCVA interactions. A positive change from baseline indicated improvement.
Secondary Outcomes
- Change From Baseline in BCVA in Study Eye up to Month 2(Baseline, Month 1, Month 2)
- Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye(Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
- Change From Baseline in Central Subfield Volume (CSFV) in Study Eye(Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
- Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline(Baseline, Month 2, Month 6, Month 12)
- Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline(Baseline, Month 2, Month 6, Month 12)
- Number of Participants With Presence of Active Chorioretinal Leakage(Baseline, Month 2, Month 6, Month 12)
- Number of Participants With Ranibizumab Treatments in Study Eye(Month 12)
- Average Change From Baseline in BCVA(Baseline (BL), Month 1 through Month 6, Month 1 through Month 12)
- Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters(Month 2, Month 6, Month 12)
- Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss(Month 2, Month 6, Month 12)
- Number of Participants With Requirement for Rescue Treatment at Month 1(Month 1)
- Number of Participants With Re-treatments(Month 12)
- Number of Primary Reasons for Decision to Treat by Investigator(Month 12)