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Intravitreal Triamcinolone Acetonide for Diabetic Macular Edema

NCT ID: NCT00476918

Last Updated: 2007-05-22

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

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-12-31

Brief Summary

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Efficacy duration of triamcinolone acetonide (steroid) for treatment of diabetic macular edema. Furthermore, dosage dependency of triamcinolone acetonide comparing a high dosage versus a low dosage.

Detailed Description

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Patients with diabetic retinopathy suffer from visual acuity loss caused by diabetic macular edema. Intravitreal injected Triamcinolone Acetonide (steroid) reduces macular edema and increases visual acuity. The duration of its effect is however limited. Therefore, several injections are necessary.

In this study a dosage dependency of triamcinolone acetonide (high dosage vs low dosage) is performed. The primary outcome parameters are the number of treatments and the efficacy of each injection.

Conditions

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Diabetic Retinopathy Diabetic Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Intravitreal injection (triamcinolone acetonide)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* diabetic macular edema and visual acuity between 20/200 and 20/40 age over 18 years

Exclusion Criteria

* recent treatment with laser photocoagulation or intravitreal drugs
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Principal Investigators

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Jost Jonas, PhD MD

Role: STUDY_DIRECTOR

Dep of Ophthalmology, University of Mannheim

Locations

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Dep of Ophthalmology, University of Mannheim

Mannheim, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Ulrich HM Spandau, PhD MD

Role: CONTACT

[email protected]
+496213832242

Anne Wickenhaeuser, MD

Role: CONTACT

anne.wickenhä[email protected]
+496213832242

Other Identifiers

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Insurance no.: 20-770-968594

Identifier Type: -

Identifier Source: secondary_id

21091968

Identifier Type: -

Identifier Source: org_study_id