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Combined Vitrectomy and Triamcinolone in Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO)

Sponsor
Helse Stavanger HF (Other)
Overall Status
Terminated
CT.gov ID
NCT00642226
Collaborator
(none)
34
Enrollment
1
Location
2
Arms
84
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Grid Laser
  • Procedure: Vitrectomy and 20 mg triamcinolone
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Nov 1, 2006
Actual Primary Completion Date :
Nov 1, 2013
Actual Study Completion Date :
Nov 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Grid Laser

Procedure: Grid Laser
ETDRS Grid Laser
Other Names:
  • Laser photocoagulation of macular edema

    		•
    Experimental: 2

    Vitrectomy in combination with 20 mg triamcinolone

    Procedure: Vitrectomy and 20 mg triamcinolone
    Pars plana vitrectomy is followed by an injection of 20 mg purified triamcinolone acetate
    Other Names:
  • PPV with induction of posterior vitreous detachment

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Visual acuity (ETDRS) [12 and 36 Months]

    Secondary Outcome Measures

    1. Retinal thickening measured on OCT. [12 and 36 Months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stavanger University Hospital, Department of Ophthalmology Stavanger Norway 4018

    Sponsors and Collaborators

    • Helse Stavanger HF

    Investigators

    • Study Director: Johan Seland, PhD, Helse Stavanger HF

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Helse Stavanger HF
    ClinicalTrials.gov Identifier:
    NCT00642226
    Other Study ID Numbers:
    • 3.2006.1159(REK)
    • 3.2006.1159
    • 14836
    First Posted:
    Mar 24, 2008
    Last Update Posted:
    Jan 6, 2014
    Last Verified:
    Jan 1, 2014
    Keywords provided by Helse Stavanger HF
    Branch Retinal Vein Occlusion
    BRVO
    Macular Edema
    Triamcinolone
    Vitrectomy
    Additional relevant MeSH terms:
    Macular Edema
    Retinal Vein Occlusion
    Edema
    Triamcinolone

    Study Results

    No Results Posted as of Jan 6, 2014