Safety and Efficacy of Dexamethasone as Adjunctive Therapy to Ranibizumab in Subjects With Choroidal Neovascularization and Age-Related Macular Degeneration
Overview
- Phase
- Phase 2
- Intervention
- 700 ug dexamethasone
- Conditions
- Subfoveal Choroidal Neovascularization
- Sponsor
- Allergan
- Enrollment
- 4
- Primary Endpoint
- Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
Brief Summary
This study will evaluate the safety and efficacy of dexamethasone (OZURDEX®) as adjunctive therapy to ranibizumab (LUCENTIS®) compared with ranibizumab alone in the treatment of patients with choroidal neovascularization secondary to age-related macular degeneration
Investigators
Eligibility Criteria
Inclusion Criteria
- •Received at least 2 and no more than 3 monthly Lucentis or Avastin injections
- •Last Lucentis or Avastin was injected approximately 4 weeks prior to screening
- •Visual acuity between 20/320 and 20/40
Exclusion Criteria
- •Active ocular infection
- •Contraindication to pupil dilation in either eye
- •Eye surgery including cataract surgery and/or laser of any type within 3 months
Arms & Interventions
700 ug dexamethasone and ranibizumab
Intravitreal injection of 700 ug dexamethasone and ranibizumab into study eye
Intervention: 700 ug dexamethasone
700 ug dexamethasone and ranibizumab
Intravitreal injection of 700 ug dexamethasone and ranibizumab into study eye
Intervention: ranibizumab
ranibizumab and sham
Intravitreal injection of ranibizumab and Sham into study eye
Intervention: ranibizumab
ranibizumab and sham
Intravitreal injection of ranibizumab and Sham into study eye
Intervention: sham
Outcomes
Primary Outcomes
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12
Time Frame: Baseline, Month 12
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Secondary Outcomes
- The Percentage of Patients Having 15 or More Letter Improvement From Baseline in Best Corrected Visual Acuity at Month 12(Baseline, Month 12)
- Change From Baseline in Central Retinal Thickness at Month 12 as Measured by Optical Coherence Tomography(Baseline, Month 12)
- Change From Baseline in Area Leakage of Choroidal Neovascularization at Month 12 as Measured by Fluorescein Angiography(Baseline, Month 12)