NCT00476918

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2006

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

May 22, 2007

Status Verified

May 1, 2007

First QC Date

May 21, 2007

Last Update Submit

May 21, 2007

Conditions

Diabetic RetinopathyDiabetic Macular Edema

Keywords

diabetic macular edematriamcinolone acetonideintravitrealsteroid

Outcome Measures

Primary Outcomes (1)

  • Visual acuity, no of treatments, duration of efficacy

    12 months

Secondary Outcomes (1)

  • intraocular pressure, retinal thickness

    12 months

Interventions

Intravitreal injection (triamcinolone acetonide)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • recent treatment with laser photocoagulation or intravitreal drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep of Ophthalmology, University of Mannheim

Mannheim, 68167, Germany

RECRUITING

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Intravitreal InjectionsTriamcinolone Acetonide

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Injections, IntraocularInjectionsDrug Administration RoutesDrug TherapyTherapeuticsTriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Jost Jonas, PhD MD

    Dep of Ophthalmology, University of Mannheim

    STUDY DIRECTOR

Central Study Contacts

Ulrich HM Spandau, PhD MD

CONTACT

+496213832242ulrich.spandau@augen.ma.uni-heidelberg.de

Anne Wickenhaeuser, MD

CONTACT

+496213832242anne.wickenhäuser@augen.ma.uni-heidelberg.de

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 21, 2007

First Posted

May 22, 2007

Study Start

July 1, 2006

Study Completion

December 1, 2007

Last Updated

May 22, 2007

Record last verified: 2007-05

Locations

DE(1)