A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion
1 other identifier
interventional
668
13 countries
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2004
Typical duration for phase_3
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 5, 2008
CompletedResults Posted
Study results publicly available
August 26, 2009
CompletedApril 23, 2019
April 1, 2019
3.3 years
September 12, 2005
July 15, 2009
April 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 are presented.
Day 180
Secondary Outcomes (3)
Change From Baseline in Retinal Thickness in the Study Eye
Baseline, Day 90, Day 180
Percentage of Patients With a Change From Baseline in BCVA by Category
Baseline, Day 90
Percentage of Patients With a Change From Baseline in BCVA by Category
Baseline, Day 180
Study Arms (3)
700 µg Dexamethasone
EXPERIMENTAL700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
350 µg Dexamethasone followed by 700 µg Dexamethasone
EXPERIMENTAL350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
Sham Injection followed by 700 µg Dexamethasone
SHAM COMPARATORSham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
Interventions
700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180.
350 µg Dexamethasone intravitreal implant administered on Day 0.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (13)
Unknown Facility
Houston, Texas, United States
Unknown Facility
São Paulo, Brazil
Unknown Facility
Mississauga, Ontario, Canada
Unknown Facility
Bogotá, Colombia
Unknown Facility
Kowloon, Hong Kong
Unknown Facility
Tamil Nadu, India
Unknown Facility
Udine, Italy
Unknown Facility
Auckland, New Zealand
Unknown Facility
Poznan, Poland
Unknown Facility
Singapore, Singapore
Unknown Facility
Seoul, South Korea
Unknown Facility
Alicante, Spain
Unknown Facility
London, United Kingdom
Related Publications (1)
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.
PMID: 20417567BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Allergan, Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 15, 2005
Study Start
November 1, 2004
Primary Completion
March 1, 2008
Study Completion
September 5, 2008
Last Updated
April 23, 2019
Results First Posted
August 26, 2009
Record last verified: 2019-04