Back to resultsSafety and Efficacy of a New Treatment as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) Treatment in Patients With 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
sham
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 subfoveal choroidal neovascularization (CNV) (classic and/or occult) secondary to AMD
- Visual Acuity between 20/40 and 20/400 in the study eye
Exclusion Criteria:
- Any intraocular surgery within 3 months
- Glaucoma
- Cataract
- High eye pressure
- Uncontrolled systemic disease
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
dexamethasone and ranibizumab
sham and ranibizumab
Arm Description
Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
Outcomes
Primary Outcome Measures
Injection Free Interval
The injection free interval was defined as the number of days between receiving the second ranibizumab injection (day 7 to 14) to the investigator's determination of eligibility to receive a third ranibizumab injection in the study eye.
Secondary Outcome Measures
Change From Baseline in the Best Corrected Visual Acuity (BCVA) at Week 25
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. 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 the Mean Central Retinal Subfield Thickness at Week 25 as Assessed by Optical Coherence Tomography (OCT) in the Study Eye
Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at baseline and Month 25.
Change From Screening in the Area of Leakage From Choroidal Neovascularization (CNV) at Week 25 as Assessed by Fluorescein Angiography in the Study Eye
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 Screening and Week 25.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00511706
Brief Title
Safety and Efficacy of a New Treatment as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) Treatment in Patients With Age-Related Macular Degeneration (AMD)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2007 (Actual)
Primary Completion Date
March 1, 2009 (Actual)
Study Completion Date
March 1, 2009 (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 implant of dexamethasone with Anti-VEGF treatment vs. Anti-VEGF alone (with sham dexamethasone injection) in patients with subfoveal 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
Choroidal Neovascularization, Age-Related Maculopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
243 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dexamethasone and ranibizumab
Arm Type
Experimental
Arm Description
Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
Arm Title
sham and ranibizumab
Arm Type
Sham Comparator
Arm Description
Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Other Intervention Name(s)
Posurdex
Intervention Description
Intravitreal injection of dexamethasone 700 µg at Day 1.
Intervention Type
Biological
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis®
Intervention Description
Ranibizumab 500 µg at day -30 and Day 7-14.
Intervention Type
Other
Intervention Name(s)
sham
Intervention Description
Sham needle-less injection administered in the study eye at Day 1.
Primary Outcome Measure Information:
Title
Injection Free Interval
Description
The injection free interval was defined as the number of days between receiving the second ranibizumab injection (day 7 to 14) to the investigator's determination of eligibility to receive a third ranibizumab injection in the study eye.
Time Frame
Week 1 to Week 25
Secondary Outcome Measure Information:
Title
Change From Baseline in the Best Corrected Visual Acuity (BCVA) at Week 25
Description
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. 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 25
Title
Change From Baseline in the Mean Central Retinal Subfield Thickness at Week 25 as Assessed by Optical Coherence Tomography (OCT) in the Study Eye
Description
Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at baseline and Month 25.
Time Frame
Baseline, Week 25
Title
Change From Screening in the Area of Leakage From Choroidal Neovascularization (CNV) at Week 25 as Assessed by Fluorescein Angiography in the Study Eye
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 Screening and Week 25.
Time Frame
Screening (-Week 28), Week 25
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 subfoveal choroidal neovascularization (CNV) (classic and/or occult) secondary to AMD
Visual Acuity between 20/40 and 20/400 in the study eye
Exclusion Criteria:
Any intraocular surgery within 3 months
Glaucoma
Cataract
High eye pressure
Uncontrolled systemic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Boynton Beach
State/Province
Florida
Country
United States
City
Parramatta
State/Province
New South Wales
Country
Australia
City
Paris
Country
France
City
Tel Aviv
Country
Israel
City
Milano
Country
Italy
City
Seoul
Country
Korea, Republic of
City
Auckland
Country
New Zealand
City
Coimbra
Country
Portugal
City
Southampton
State/Province
Hampshire
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
26088793
Citation
Kuppermann BD, Goldstein M, Maturi RK, Pollack A, Singer M, Tufail A, Weinberger D, Li XY, Liu CC, Lou J, Whitcup SM; Ozurdex(R) ERIE Study Group. Dexamethasone Intravitreal Implant as Adjunctive Therapy to Ranibizumab in Neovascular Age-Related Macular Degeneration: A Multicenter Randomized Controlled Trial. Ophthalmologica. 2015;234(1):40-54. doi: 10.1159/000381865. Epub 2015 Jun 18.
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Safety and Efficacy of a New Treatment as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) Treatment in Patients With Age-Related Macular Degeneration (AMD)
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