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Efficacy and Safety Study of Intravitreal Triamcinolone to Treat Diffuse Diabetic Macular Edema

NCT00309192 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 292

Last updated 2023-03-14

No results posted yet for this study

Summary

The purpose of this study is to determine whether intravitreal injection of Triamcinolone Acetonide is effective in the treatment of Clinically Significant Diffuse Macular Edema due to Type 2 Diabetes Mellitus.

Conditions

Interventions

DRUG

Triamcinolone Acetonide

Intravitreal Injection 4mg single dose

PROCEDURE

Grid laser

Grid laser as specified in ETDRS

PROCEDURE

Sham Injection

Simulation procedure for triamcinolone injection

Sponsors & Collaborators

  • Fondo de Investigacion Sanitaria

    collaborator OTHER

  • Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

    lead OTHER

Principal Investigators

  • José Carlos Pastor Jimeno, MD, PhD · IOBA - Instituto de Oftalmobiología Aplicada - Universidad de Valladolid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • Spain

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 NCT00309192 on ClinicalTrials.gov