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Intravitreal Triamcinolone Acetonide for Treatment of Refractory Diffuse Diabetic Macular Edema

NCT00407849 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2008-05-07

No results posted yet for this study

Summary

Phase I/II study with intravitreal triamcinolone acetonide microspheres(RETAAC)for treatment of diffuse diabetic macular edema unresponsive to laser photocoagulation. Study hypothesis is that single intravitreal injection of RETAAC is safe and efficient compared to conventional treatment. Fifty patients will participate in this study and will be randomized into treatment and observation groups. Efficacy will be evaluated by best corrected visual acuity and macular thickness measured by optic coherence tomography (OCT) after 12 months of treatment.

Conditions

Interventions

DRUG

triamcinolone acetonide

Intravitreal injection

Sponsors & Collaborators

  • Federal University of São Paulo

    lead OTHER

Principal Investigators

  • Jose A Cardillo, M.D · Federal University of São Paulo

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2007-12-31
Completion
2008-08-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00407849 on ClinicalTrials.gov