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

Phase 2

Terminated

• Conditions: Subfoveal Choroidal Neovascularization; Age-Related Maculopathy
• Interventions: Drug: 700 ug dexamethasone; Biological: ranibizumab; Other: sham

• Registration Number: NCT01122511
• Lead Sponsor: Allergan

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-11
• Study First Submitted QC: 2010-05-11
• Study First Posted: 2010-05-13
• Study Start: 2010-08
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Disposition First Submitted: 2012-05-25
• Disposition First Submitted QC: 2012-05-25
• Disposition First Posted: 2012-06-01
• Status Verified: 2012-08
• Results First Submitted: 2012-08-01
• Results First Submitted QC: 2012-08-01
• Last Update Submitted: 2012-08-01
• Results First Posted: 2012-09-05
• Last Update Posted: 2012-09-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
700 ug dexamethasone and ranibizumab	ranibizumab	Intravitreal injection of 700 ug dexamethasone and ranibizumab into study eye
ranibizumab and sham	ranibizumab	Intravitreal injection of ranibizumab and Sham into study eye
ranibizumab and sham	sham	Intravitreal injection of ranibizumab and Sham into study eye
700 ug dexamethasone and ranibizumab	700 ug dexamethasone	Intravitreal injection of 700 ug dexamethasone and ranibizumab into study eye

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12	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 Outcome Measures

Name	Time	Method
The Percentage of Patients Having 15 or More Letter Improvement From Baseline in Best Corrected Visual Acuity at Month 12	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	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	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.