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

This study has been terminated.
(Due to recruiting problems and the introduction of new treatment strategies (ranibizumab and dexamethasone implant).)
Sponsor:
Information provided by (Responsible Party):
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT00642226
First received: March 19, 2008
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Helse Stavanger HF:

Primary Outcome Measures:
  • Visual acuity (ETDRS) [ Time Frame: 12 and 36 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Retinal thickening measured on OCT. [ Time Frame: 12 and 36 Months ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: November 2006
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642226

Locations
Norway
Stavanger University Hospital, Department of Ophthalmology
Stavanger, Norway, 4018
Sponsors and Collaborators
Helse Stavanger HF
Investigators
Study Director: Johan Seland, PhD Helse Stavanger HF
  More Information

No publications provided

Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT00642226     History of Changes
Other Study ID Numbers: 3.2006.1159(REK), 3.2006.1159, 14836
Study First Received: March 19, 2008
Last Updated: January 3, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services

Keywords provided by Helse Stavanger HF:
Branch Retinal Vein Occlusion
BRVO
Macular Edema
Triamcinolone
Vitrectomy

Additional relevant MeSH terms:
Edema
Retinal Vein Occlusion
Macular Edema
Signs and Symptoms
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Macular Degeneration
Retinal Degeneration
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014