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

NCT ID: NCT00642226

Last Updated: 2014-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Branch Retinal Vein Occlusion Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Grid Laser

Group Type ACTIVE_COMPARATOR

Grid Laser

Intervention Type PROCEDURE

ETDRS Grid Laser

2

Vitrectomy in combination with 20 mg triamcinolone

Group Type EXPERIMENTAL

Vitrectomy and 20 mg triamcinolone

Intervention Type PROCEDURE

Pars plana vitrectomy is followed by an injection of 20 mg purified triamcinolone acetate

Interventions

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Grid Laser

ETDRS Grid Laser

Intervention Type PROCEDURE

Vitrectomy and 20 mg triamcinolone

Pars plana vitrectomy is followed by an injection of 20 mg purified triamcinolone acetate

Intervention Type PROCEDURE

Other Intervention Names

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Laser photocoagulation of macular edema PPV with induction of posterior vitreous detachment

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helse Stavanger HF

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johan Seland, PhD

Role: STUDY_DIRECTOR

Helse Stavanger HF

Locations

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Stavanger University Hospital, Department of Ophthalmology

Stavanger, , Norway

Site Status

Countries

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Norway

Other Identifiers

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3.2006.1159

Identifier Type: OTHER

Identifier Source: secondary_id

14836

Identifier Type: OTHER

Identifier Source: secondary_id

3.2006.1159(REK)

Identifier Type: -

Identifier Source: org_study_id

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