Back to resultsSafety and Efficacy of Dexamethasone as Adjunctive Therapy to Ranibizumab in Subjects With Choroidal Neovascularization and Age-Related Macular Degeneration
Primary Purpose
Subfoveal Choroidal Neovascularization, Age-Related Maculopathy
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
700 ug dexamethasone
ranibizumab
sham
Sponsored by
About this trial
This is an interventional treatment trial for Subfoveal Choroidal Neovascularization
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
700 ug dexamethasone and ranibizumab
ranibizumab and sham
Arm Description
Intravitreal injection of 700 ug dexamethasone and ranibizumab into study eye
Intravitreal injection of ranibizumab and Sham into study eye
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01122511
Brief Title
Safety and Efficacy of Dexamethasone as Adjunctive Therapy to Ranibizumab in Subjects With Choroidal Neovascularization and Age-Related Macular Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated early due to difficulties with patient recruitment.
Study Start Date
August 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subfoveal Choroidal Neovascularization, Age-Related Maculopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
700 ug dexamethasone and ranibizumab
Arm Type
Experimental
Arm Description
Intravitreal injection of 700 ug dexamethasone and ranibizumab into study eye
Arm Title
ranibizumab and sham
Arm Type
Active Comparator
Arm Description
Intravitreal injection of ranibizumab and Sham into study eye
Intervention Type
Drug
Intervention Name(s)
700 ug dexamethasone
Other Intervention Name(s)
OZURDEX®
Intervention Description
Intravitreal injection of 700 ug dexamethasone into study eye
Intervention Type
Biological
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis®
Intervention Description
Intravitreal injection of ranibizumab into study eye
Intervention Type
Other
Intervention Name(s)
sham
Intervention Description
Sham needle-less injection administered in the study eye
Primary Outcome Measure Information:
Title
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12
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, Month 12
Secondary Outcome Measure Information:
Title
The Percentage of Patients Having 15 or More Letter Improvement From Baseline in Best Corrected Visual Acuity at Month 12
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, Month 12
Title
Change From Baseline in Central Retinal Thickness at Month 12 as Measured by Optical Coherence Tomography
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 Month 12.
Time Frame
Baseline, Month 12
Title
Change From Baseline in Area Leakage of Choroidal Neovascularization at Month 12 as Measured by Fluorescein Angiography
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 was performed on the study eye after dilation at baseline and Week 12.
Time Frame
Baseline, Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Fort Myers
State/Province
Florida
Country
United States
City
Abilene
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Dexamethasone as Adjunctive Therapy to Ranibizumab in Subjects With Choroidal Neovascularization and Age-Related Macular Degeneration
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