NCT01986907CompletedPhase 4
A 12 Months, Prospective, Multicenter, Open-label, Single Arm Interventional Study Assessing the Safety and Tolerability of 0.5 mg Ranibizumab in Mono/Bilateral Wet AMD Patients in Eyes With (Best-Corrected Distance Visual Acuity) BCVA Below 2/10 and/or Second Affected Eye
Novartis Pharmaceuticals1 site in 1 country1,049 target enrollmentStarted: March 4, 2014Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 1,049
- Locations
- 1
- Primary Endpoint
- Number of Participants With Systemic Drug-related Adverse Events
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of ranibizumab in patients affected by wet age related macular degeneration (wAMD).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Active intraocular inflammation (grade trace or above) in either eye Any ocular or periocular active infection (current or suspected), e.g. conjunctivitis, keratitis, scleritis, uveitis, endophtalmitis, in either eye Risk factors for retinal pigment epithelial tear (including pigment epithelial retinal detachment) Ocular disorders that may confound interpretation of results compromise visual acuity or require medical or surgical intervention during the study period including cataract, retinal vascular occlusion, retinal detachment or macular hole Uncontrolled glaucoma in either eye (IOP ≥ 30 mmHg on medication or according to investigator's judgment) History of vitrectomy in the study eye History of stroke or transient ischemic attack Systemic treatment with any VEGF inhibitor in the 90 days prior to study enrollment Ocular treatment of the study eye with any anti-angiogenic drugs within 1 month prior to study enrollment Any intraocular surgery in the study eye within 28 days prior to enrollment Women of childbearing potential UNLESS using effective contraception during treatment Pregnant or lactating women Simultaneous participation in a study that includes administration of any investigational drug Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation Inability to comply with study procedures.
Arms & Interventions
Ranibizumab
Experimental
Administered as an Intravitreal injection
Intervention: ranibizumab (Drug)
Outcomes
Primary Outcomes
Number of Participants With Systemic Drug-related Adverse Events
Time Frame: Baseline to Month 12
Monitoring and recording all adverse events, including serious adverse events.
Number of Eyes With Ocular Drug-related Adverse Events
Time Frame: Baseline to Month 12
Monitoring and recording all adverse events, including serious adverse events.
Secondary Outcomes
- Overall Number of Ranibizumab Injections(Baseline to month 12)
- Time Interval Between Injections in Bilateral Disease(Baseline to month 12)
- Mean Number of Injections Per Patient(Baseline to month 12)
Investigators
Study Sites (1)
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