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

Sponsor:	Helse Stavanger HF
Information provided by:	Helse Stavanger HF
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:	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:

Genetics Home Reference related topics: age-related macular degeneration 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 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 ]

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
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

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:	Vegard Forsaa/MD, Stavanger University Hospital
ClinicalTrials.gov Identifier:	NCT00642226 History of Changes
Other Study ID Numbers:	3.2006.1159(REK), 3.2006.1159(REK), 14836(NSD)
Study First Received:	March 19, 2008
Last Updated:	October 8, 2009
Health Authority:	Norway: The National Committees for Research Ethics in Norway; 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
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
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 February 09, 2012