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

This study is ongoing, but not recruiting participants.

First Received: March 19, 2008 Last Updated: October 8, 2009 History of Changes

Sponsor:	Stavanger University Hospital
Information provided by:	Stavanger University Hospital
ClinicalTrials.gov Identifier:	NCT00642226

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
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:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide

U.S. FDA Resources

Further study details as provided by Stavanger University Hospital:

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 ]

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

Arms	Assigned Interventions
1: Active Comparator Grid Laser	Procedure: Grid Laser ETDRS Grid Laser
2: Experimental 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

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

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

Stavanger University Hospital

Investigators

Study Director:

Johan Seland, PhD

Stavanger University Hospital

More Information

No publications provided

Responsible Party:	Stavanger University Hospital ( Vegard Forsaa/MD )
Study ID Numbers:	3.2006.1159(REK), 3.2006.1159(REK), 14836(NSD)
Study First Received:	March 19, 2008
Last Updated:	October 8, 2009
ClinicalTrials.gov Identifier:	NCT00642226 History of Changes
Health Authority:	Norway: The National Committees for Research Ethics in Norway; Norway: Norwegian Social Science Data Services

Keywords provided by Stavanger University Hospital:

Branch Retinal Vein Occlusion
BRVO
Macular Edema
Triamcinolone
Vitrectomy

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Edema
Hormones
Triamcinolone hexacetonide
Signs and Symptoms
Macular Edema
Triamcinolone Acetonide
Retinal Vein Occlusion
Therapeutic Uses
Triamcinolone

Cardiovascular Diseases
Venous Thrombosis
Retinal Diseases
Eye Diseases
Vascular Diseases
Retinal Degeneration
Macular Degeneration
Enzyme Inhibitors
Triamcinolone diacetate
Glucocorticoids
Immunosuppressive Agents
Thrombosis
Pharmacologic Actions
Embolism and Thrombosis

ClinicalTrials.gov processed this record on February 08, 2010