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

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ClinicalTrials.gov Identifier: NCT00642226
Recruitment Status : Terminated (Due to recruiting problems and the introduction of new treatment strategies (ranibizumab and dexamethasone implant).)
First Posted : March 24, 2008
Last Update Posted : January 6, 2014
Sponsor:
Information provided by (Responsible Party):
Helse Stavanger HF

Study Description
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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
Branch Retinal Vein Occlusion Macular Edema Procedure: Grid Laser Procedure: Vitrectomy and 20 mg triamcinolone Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : November 2006
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Grid Laser
 Procedure: Grid Laser
ETDRS Grid Laser
Other Name: 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 Name: PPV with induction of posterior vitreous detachment


Outcome Measures
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Primary Outcome Measures :
  1. Visual acuity (ETDRS) [ Time Frame: 12 and 36 Months ]

Secondary Outcome Measures :
  1. Retinal thickening measured on OCT. [ Time Frame: 12 and 36 Months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00642226


Locations
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Norway
Stavanger University Hospital, Department of Ophthalmology
Stavanger, Norway, 4018
Sponsors and Collaborators
Helse Stavanger HF
Investigators
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Study Director: Johan Seland, PhD Helse Stavanger HF
More Information
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Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT00642226    
Other Study ID Numbers: 3.2006.1159(REK)
3.2006.1159 ( Other Identifier: REK Vest, Norway )
14836 ( Other Identifier: NSD, Norway )
First Posted: March 24, 2008    Key Record Dates
Last Update Posted: January 6, 2014
Last Verified: January 2014
Keywords provided by Helse Stavanger HF:
Branch Retinal Vein Occlusion
BRVO
Macular Edema
Triamcinolone
Vitrectomy
Additional relevant MeSH terms:
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Macular Edema
Retinal Vein Occlusion
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
 Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Triamcinolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs