Intravitreal Triamcinolone Acetonide for Treatment of Refractory Diffuse Diabetic Macular Edema

May 6, 2008 updated by: Federal University of São Paulo

Phase I/II Study of Intravitreal Triamcinolone Acetonide Microspheres for Treatment of Diffuse Diabetic Macular Edema Unresponsive to Conventional Laser Photocoagulation Treatment.

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.

Study Overview

Status

Unknown

Conditions

Diabetic Retinopathy

Intervention / Treatment

Drug: triamcinolone acetonide

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2
Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Brazil
- SP
  - Sao Paulo, SP, Brazil, 04023-062
    - Vision Institute, Federal University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Diabetes mellitus (type 1 or 2)
Diabetic macular edema in study eye associated to diabetic retinopathy
Diffuse macular edema defined as macular thickening determined by biomicroscopy and fluorescein angiography.
Best corrected visual acuity between 34 (20/200) and 68 letters (20/50).
Macular thickness greater than 300 mcm on OCT.

Exclusion Criteria:

Uncontrolled systemic disease
Start of medical therapy for diabetes or change in treatment from oral to insulin four months before initial visit.
HbA1c levels greater than 10%
Presence of retinal venous occlusion, cystoid macular edema,or other condition that would contribute to macular edema.
Presence of epiretinal membrane
Presence of vitreomacular traction in the study eye.
Aphakic or anterior chamber intraocular lens in the study eye.
Neovascularization of disc or elsewhere in the study eye.
History or presence of choroidal neovascularization in the study eye.
Presence of rubeosis irides in the study eye.
Eye opacity that interfere with clinical documentation and photography.
Intra-ocular surgery 90 days before initial visit.
Previous vitrectomy in study eye.
Previous history of intravitreal or periocular corticoid or any other intravitreal drug in study eye.
Scheduled surgery for study eye.
Patients with known allergies to fluorescein, iodo-povidone or any component of study drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Best corrected visual acuity after 12 months of single intravitreal injection of triamcinolone acetonide. Time Frame: 12 months	12 months
Macular thickness measured by optical coherence tomography (OCT) after 12 months of treatment. Time Frame: 12 months	12 months
Safety of intravitreal triamcinolone acetonide after 12 months of treatment. Time Frame: 12 months	12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

Principal Investigator: Jose A Cardillo, M.D, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Anticipated)

August 1, 2008

Study Registration Dates

First Submitted

December 4, 2006

First Submitted That Met QC Criteria