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

Conditions

• Age-Related Maculopathy
• Subfoveal Choroidal Neovascularization

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 700 ug dexamethasone — DRUG
  Intravitreal injection of 700 ug dexamethasone into study eye
• ranibizumab — BIOLOGICAL
  Intravitreal injection of ranibizumab into study eye
• sham — OTHER
  Sham needle-less injection administered in the study eye

Study Details

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

Key Dates

First listed

May 13, 2010

Start date

Aug 31, 2010

Status verified

Aug 2012

Primary completion

May 31, 2011

Completion

May 31, 2011

Study Design

Enrollment

4 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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

Primary Outcome Measure

Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 [ Time Frame: Baseline, Month 12 ]

Locations (2)