ESBA1008 Safety, Tolerability and Effects in Wet Age-Related Macular Degeneration (AMD) Patients
- Sponsor
- Alcon Research
- Study ID
- NCT01304693
- Phase
- PHASE1/PHASE2
- Status
- Completed
Conditions
- Exudative Age-Related Macular Degeneration
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- ESBA1008 solution — BIOLOGICALAdministered as a single intravitreal injection (Dose A, Dose B, Dose C, Dose D)
- Ranibizumab 0.5 mg — BIOLOGICALAdministered as a single intravitreal injection
Study Details
The purpose of this study was to assess the safety, tolerability, and the effects of treatment on ocular outcomes following a single intravitreal administration of ESBA1008 compared with LUCENTIS® in patients with exudative age-related macular degeneration (AMD).
Key Dates
- First listed
- Feb 25, 2011
- Start date
- Oct 31, 2010
- Status verified
- Jul 2014
- Primary completion
- Mar 31, 2013
- Completion
- Mar 31, 2013
Study Design
- Enrollment
- 376 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: ESBA1008ESBA1008 solution, single intravitreal injection
- Active Comparator: LUCENTISRanibizumab 0.5 mg, single intravitreal injection
Primary Outcome Measure
Change From Baseline at Month 1 in Central Subfield Thickness (CSFT) as Measured by Spectral Domain Ocular Coherence Tomography (SD-OCT) [ Time Frame: Baseline, Month 1 ]