Safety and Tolerability of Ranibizumab in Mono/Bilateral Wet Age Related Macular Degeneration (w-AMD) Patients in Eyes With BCVA<2/10 and/or 2nd Affected Eye
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT01986907
- Phase
- PHASE4
- Status
- Completed
Conditions
- Wet Age Related Macular Degeneration
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- ranibizumab — DRUGAll patients will receive ranibizumab 0.5 mg/0.05 ml according to approved label: treatment is given monthly until maximum VA is achieved (i.e. stable VA for three consecutive monthly assessments performed while on ranibizumab treatment). Thereafter according to approved label, patients should be monitored monthly for visual acuity and treatment is to be resumed when monitoring indicates loss of visual acuity due to disease activity. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections).
Study Details
The purpose of this study is to evaluate the safety and efficacy of ranibizumab in patients affected by wet age related macular degeneration (wAMD).
Key Dates
- First listed
- Nov 19, 2013
- Start date
- Mar 4, 2014
- Status verified
- May 2019
- Primary completion
- Jun 15, 2016
- Completion
- Jun 15, 2016
Study Design
- Enrollment
- 1,049 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: RanibizumabAdministered as an Intravitreal injection
Primary Outcome Measure
Number of Participants With Systemic Drug-related Adverse Events [ Time Frame: Baseline to Month 12 ]