Safety and Efficacy of a New Therapy as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) in Subjects With Wet Age-Related Macular Degeneration (AMD)

Choroidal Neovascularization Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00775411
• Other study ID #: 206207-019
• Status: Completed
• Phase: Phase 2
• First received: October 16, 2008
• Last updated: August 1, 2012
• Start date: November 2008
• Est. completion date: April 2010

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

The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant as adjunctive therapy to Anti-VEGF treatment in the study eye of treatment naïve subjects with choroidal neovascularization secondary to age-related macular degeneration. Subjects will be followed for 26 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• 50 years of age or older with active subfoveal choroidal neovascularization (CNV) secondary to AMD

• Central retinal thickness = 300 µm

• Visual acuity between 20/400 and 20/32

• Eligible for Anti-VEGF therapy

Exclusion Criteria:

• Previous treatment for CNV due to AMD

• High eye pressure

• Glaucoma

• Uncontrolled systemic disease

• Known allergy to the study medications

• Recent eye surgery or injections in the eye

• Female subjects that are of childbearing potential

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• dexamethasone
700 µg dexamethasone intravitreal injection at Day 1 in the study eye.

Biological:
• ranibizumab
Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion in the study eye.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Australia,  Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) at Week 4	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 Week 4.	Baseline, Week 4	No
Secondary	Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 26	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, Week 26	No
Secondary	Percentage of Participants With Fluorescein Leakage Improved, Unchanged and Worsened From Baseline as Assessed by Fluorescein Angiography at Week 26	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 at Week 26 was compared to FA at Baseline. The percentage of participants in each of the following categories is reported: Improved (Leakage area decreased >=10%), Unchanged (Leakage area changed < 10%) and Worsened (Leakage area increased >=10%).	Baseline, Week 26	No