Back to resultsCombined Vitrectomy and Triamcinolone in Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO)
Primary Purpose
Branch Retinal Vein Occlusion, Macular Edema
Status
Terminated
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Grid Laser
Vitrectomy and 20 mg triamcinolone
Sponsored by
About this trial
This is an interventional treatment trial for Branch Retinal Vein Occlusion focused on measuring Branch Retinal Vein Occlusion, BRVO, Macular Edema, Triamcinolone, Vitrectomy
Eligibility Criteria
Inclusion Criteria:
- Macular edema secondary to BRVO
- Best Corrected Visual Acuity of ≤ 20/40 on ETDRS chart
- Duration no shorter than 3 months
- Duration no longer than 12 months
Exclusion Criteria:
- Proliferations in study eye
- Blod in vitreous cavity
- Previous fundus laser treatment
- BRVO with over 180˚ of ischemia on FA
- Age under 18
- Other eye condition which contribute to relevant loss of visual acuity
Sites / Locations
- Stavanger University Hospital, Department of Ophthalmology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Grid Laser
Vitrectomy in combination with 20 mg triamcinolone
Outcomes
Primary Outcome Measures
Visual acuity (ETDRS)
Secondary Outcome Measures
Retinal thickening measured on OCT.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00642226
Brief Title
Combined Vitrectomy and Triamcinolone in Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO)
Official Title
A Randomized Study Comparing Combined Vitrectomy and Triamcinolone to Laser Grid in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Terminated
Why Stopped
Due to recruiting problems and the introduction of new treatment strategies (ranibizumab and dexamethasone implant).
Study Start Date
November 2006 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Stavanger HF
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether pars plana vitrectomy in combination with triamcinolone acetate is effective in the treatment of macular edema due to branch retinal vein occlusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Branch Retinal Vein Occlusion, Macular Edema
Keywords
Branch Retinal Vein Occlusion, BRVO, Macular Edema, Triamcinolone, Vitrectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Grid Laser
Arm Title
2
Arm Type
Experimental
Arm Description
Vitrectomy in combination with 20 mg triamcinolone
Intervention Type
Procedure
Intervention Name(s)
Grid Laser
Other Intervention Name(s)
Laser photocoagulation of macular edema
Intervention Description
ETDRS Grid Laser
Intervention Type
Procedure
Intervention Name(s)
Vitrectomy and 20 mg triamcinolone
Other Intervention Name(s)
PPV with induction of posterior vitreous detachment
Intervention Description
Pars plana vitrectomy is followed by an injection of 20 mg purified triamcinolone acetate
Primary Outcome Measure Information:
Title
Visual acuity (ETDRS)
Time Frame
12 and 36 Months
Secondary Outcome Measure Information:
Title
Retinal thickening measured on OCT.
Time Frame
12 and 36 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Macular edema secondary to BRVO
Best Corrected Visual Acuity of ≤ 20/40 on ETDRS chart
Duration no shorter than 3 months
Duration no longer than 12 months
Exclusion Criteria:
Proliferations in study eye
Blod in vitreous cavity
Previous fundus laser treatment
BRVO with over 180˚ of ischemia on FA
Age under 18
Other eye condition which contribute to relevant loss of visual acuity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Seland, PhD
Organizational Affiliation
Helse Stavanger HF
Official's Role
Study Director
Facility Information:
Facility Name
Stavanger University Hospital, Department of Ophthalmology
City
Stavanger
ZIP/Postal Code
4018
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Combined Vitrectomy and Triamcinolone in Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO)
We'll reach out to this number within 24 hrs