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Combined Triple Procedure in Retinal Vein Occlusion (RVO)

NCT ID: NCT00805064

Last Updated: 2012-09-27

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-11-30

Brief Summary

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The aim of this pilot study was to investigate the effects of an intravitreal combination therapy using triamcinolone and bevacizumab in patients with retinal vein occlusion (RVO).

Detailed Description

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This prospective study of a case series was conducted in 47 patients (n = 47 eyes; f/m: 21/26; mean age: 66.6 years) with ischemic central RVO (CRVO) (n = 15), non-ischemic CRVO (n = 7), or branch RVO (BRVO) (n = 25). A core pars plana vitrectomy with aspiration of 1.5 ml vitreous and infusion of balanced salt solution (BSS; 1 ml), 8 mg (0.4 ml) triamcinolone, and 1.25 mg (0.1 ml) bevacizumab was performed with a single sutureless sclerotomy and a 23 gauge probe tip. At baseline and follow-up, the best corrected visual acuity (BCVA; 6 m Snellen), and intraocular pressure (IOP; Goldmann tonometry), and central macular thickness (optical coherence tomography) were determined. In addition, the need for further treatment and adverse events were monitored.

Conditions

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Retinal Vein Occlusion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ischemic CRVO

treatment was applied to this entity

Group Type ACTIVE_COMPARATOR

triamcinolone and bevacizumab

Intervention Type DRUG

non ischemic CRVO

treatment was applied to this entity

Group Type ACTIVE_COMPARATOR

triamcinolone and bevacizumab

Intervention Type DRUG

BRVO

treatment was applied to this entity

Group Type ACTIVE_COMPARATOR

triamcinolone and bevacizumab

Intervention Type DRUG

Interventions

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triamcinolone and bevacizumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Ischemic central RVO (CRVO)
* Non-ischemic CRVO
* Branch RVO (BRVO)

Exclusion Criteria

* Visual deterioration due to acute or chronic inflammation
* Post trauma
* Macular edema of other origin
* Intravitreal drug treatment within last 4 months
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Michael Koss

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Koss, MD

Role: PRINCIPAL_INVESTIGATOR

Department of VitreoRetinal Surgery ZAU JWGU

Other Identifiers

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MK-KTRVO-2008

Identifier Type: -

Identifier Source: org_study_id