Back to resultsSafety 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)
Primary Purpose
Choroidal Neovascularization, Age-Related Maculopathy
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
dexamethasone
ranibizumab
Sponsored by
About this trial
This is an interventional treatment trial for Choroidal Neovascularization
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
700 µg dexamethasone and ranibizumab
Arm Description
700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion in the study eye.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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%).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00775411
Brief Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choroidal Neovascularization, Age-Related Maculopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
700 µg dexamethasone and ranibizumab
Arm Type
Experimental
Arm Description
700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion in the study eye.
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Other Intervention Name(s)
Posurdex
Intervention Description
700 µg dexamethasone intravitreal injection at Day 1 in the study eye.
Intervention Type
Biological
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis®
Intervention Description
Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion in the study eye.
Primary Outcome Measure Information:
Title
Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) at Week 4
Description
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.
Time Frame
Baseline, Week 4
Secondary Outcome Measure Information:
Title
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 26
Description
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.
Time Frame
Baseline, Week 26
Title
Percentage of Participants With Fluorescein Leakage Improved, Unchanged and Worsened From Baseline as Assessed by Fluorescein Angiography at Week 26
Description
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%).
Time Frame
Baseline, Week 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
San Antonio
State/Province
Texas
Country
United States
City
Sydney
State/Province
New South Wales
Country
Australia
City
Manila
Country
Philippines
12. IPD Sharing Statement
Learn more about this trial
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)
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