Safety and Efficacy of Dexamethasone as Adjunctive Therapy to Ranibizumab in Subjects With Choroidal Neovascularization and Age-Related Macular Degeneration

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: May 2011

Interventions

  • Drug: 700 ug dexamethasone
    • Intravitreal injection of 700 ug dexamethasone into study eye
  • Biological: ranibizumab
    • Intravitreal injection of ranibizumab into study eye
  • Other: sham
    • Sham needle-less injection administered in the study eye

Arms, Groups and Cohorts

  • Experimental: 700 ug dexamethasone and ranibizumab
    • Intravitreal injection of 700 ug dexamethasone and ranibizumab into study eye
  • Active Comparator: ranibizumab and sham
    • Intravitreal injection of ranibizumab and Sham into study eye

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • The Percentage of Patients Having 15 or More Letter Improvement From Baseline in Best Corrected Visual Acuity 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.
  • Change From Baseline in Central Retinal Thickness at Month 12 as Measured by Optical Coherence Tomography
    • Time Frame: Baseline, Month 12
    • Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed on the study eye after pupil dilation at baseline and Month 12.
  • Change From Baseline in Area Leakage of Choroidal Neovascularization at Month 12 as Measured by Fluorescein Angiography
    • Time Frame: Baseline, Month 12
    • Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA was performed on the study eye after dilation at baseline and Week 12.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Allergan
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Director, Study Director, Allergan

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