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

Age-Related Maculopathy Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01122511
• Other study ID #: 206207-021
• Status: Terminated
• Phase: Phase 2
• First received: May 11, 2010
• Last updated: August 1, 2012
• Start date: August 2010
• Est. completion date: May 2011

Study information

• Verified date: August 2012
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Maculopathy
• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic
• Subfoveal Choroidal Neovascularization

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Best Corrected Visual Acuity (BCVA) at 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.	Baseline, Month 12	No
Secondary	The Percentage of Patients Having 15 or More Letter Improvement From Baseline in Best Corrected Visual Acuity at 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.	Baseline, Month 12	No
Secondary	Change From Baseline in Central Retinal Thickness at Month 12 as Measured by Optical Coherence Tomography	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.	Baseline, Month 12	No
Secondary	Change From Baseline in Area Leakage of Choroidal Neovascularization at Month 12 as Measured by Fluorescein Angiography	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.	Baseline, Month 12	No