Back to resultsA Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion
Primary Purpose
Macular Edema, Retinal Vein Occlusion
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
700 µg Dexamethasone
350 µg Dexamethasone
Sham Injection
Sponsored by
About this trial
This is an interventional treatment trial for Macular Edema
Eligibility Criteria
Inclusion Criteria: 18 years of age or older with macular edema resulting from retinal vein occlusion Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse) Visual acuity in other eye no worse than 20/200 Exclusion Criteria: Known anticipated need for ocular surgery within next 12 months History of glaucoma or current high eye pressure requiring more than 1 medication Diabetic retinopathy Uncontrolled systemic disease Known steroid-responder Use of systemic steroids Use of warfarin/heparin
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
700 µg Dexamethasone
350 µg Dexamethasone followed by 700 µg Dexamethasone
Sham Injection followed by 700 µg Dexamethasone
Arm Description
700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
Outcomes
Primary Outcome Measures
Cumulative Response Rate of 15 or More Letter Improvement
The cumulative response rate of 15 or more letter improvement was based on the Kaplan-Meier estimate. A Kaplan-Meier analysis takes into account patients who dropped out from the study prior to achieving the 15 letter improvement. Values ranged from 0-1, with a higher number indicating a higher probability of response.
Secondary Outcome Measures
Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye
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. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye at each visit are presented.
Change From Baseline in Retinal Thickness in the Study Eye
Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Percentage of Patients With a Change From Baseline in BCVA by Category
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. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening.
Percentage of Patients With a Change From Baseline in BCVA by Category
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. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00168324
Brief Title
A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2004 (Actual)
Primary Completion Date
March 1, 2008 (Actual)
Study Completion Date
October 1, 2008 (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 an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema, Retinal Vein Occlusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
599 (Actual)
8. Arms, Groups, and Interventions
Arm Title
700 µg Dexamethasone
Arm Type
Experimental
Arm Description
700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
Arm Title
350 µg Dexamethasone followed by 700 µg Dexamethasone
Arm Type
Experimental
Arm Description
350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
Arm Title
Sham Injection followed by 700 µg Dexamethasone
Arm Type
Sham Comparator
Arm Description
Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
Intervention Type
Drug
Intervention Name(s)
700 µg Dexamethasone
Other Intervention Name(s)
Posurdex®
Intervention Description
700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180.
Intervention Type
Drug
Intervention Name(s)
350 µg Dexamethasone
Other Intervention Name(s)
Posurdex®
Intervention Description
350 µg Dexamethasone intravitreal implant administered on Day 0.
Intervention Type
Other
Intervention Name(s)
Sham Injection
Intervention Description
Sham injection on Day 0.
Primary Outcome Measure Information:
Title
Cumulative Response Rate of 15 or More Letter Improvement
Description
The cumulative response rate of 15 or more letter improvement was based on the Kaplan-Meier estimate. A Kaplan-Meier analysis takes into account patients who dropped out from the study prior to achieving the 15 letter improvement. Values ranged from 0-1, with a higher number indicating a higher probability of response.
Time Frame
Up to 180 Days
Secondary Outcome Measure Information:
Title
Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye
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. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye at each visit are presented.
Time Frame
Day 90, Day 180
Title
Change From Baseline in Retinal Thickness in the Study Eye
Description
Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Time Frame
Baseline, Day 90, Day 180
Title
Percentage of Patients With a Change From Baseline in BCVA by Category
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. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening.
Time Frame
Baseline, Day 90
Title
Percentage of Patients With a Change From Baseline in BCVA by Category
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. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening.
Time Frame
Baseline, Day 180
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older with macular edema resulting from retinal vein occlusion
Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse)
Visual acuity in other eye no worse than 20/200
Exclusion Criteria:
Known anticipated need for ocular surgery within next 12 months
History of glaucoma or current high eye pressure requiring more than 1 medication
Diabetic retinopathy
Uncontrolled systemic disease
Known steroid-responder
Use of systemic steroids
Use of warfarin/heparin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Los Angeles
State/Province
California
Country
United States
City
Sydney
Country
Australia
City
Graz
Country
Austria
City
Halifax
State/Province
Nova Scotia
Country
Canada
City
Brno
Country
Czechia
City
Creteil
Country
France
City
Karlsruhe
Country
Germany
City
Rehovot
Country
Israel
City
Tabacalera
Country
Mexico
City
Makati
Country
Philippines
City
Coimbra
Country
Portugal
City
Arcadia
Country
South Africa
City
Kaohsiung
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
20417567
Citation
Haller JA, Bandello F, Belfort R Jr, Blumenkranz MS, Gillies M, Heier J, Loewenstein A, Yoon YH, Jacques ML, Jiao J, Li XY, Whitcup SM; OZURDEX GENEVA Study Group. Randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion. Ophthalmology. 2010 Jun;117(6):1134-1146.e3. doi: 10.1016/j.ophtha.2010.03.032. Epub 2010 Apr 24.
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A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion
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