Intravitreal Triamcinolone Acetonide for Treatment of Refractory Diffuse Diabetic Macular Edema - Full Text View

Sponsor:	Federal University of São Paulo
Information provided by:	Federal University of São Paulo
ClinicalTrials.gov Identifier:	NCT00407849

Purpose

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.

Condition	Intervention	Phase
Diabetic Retinopathy	Drug: triamcinolone acetonide	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase I/II Study of Intravitreal Triamcinolone Acetonide Microspheres for Treatment of Diffuse Diabetic Macular Edema Unresponsive to Conventional Laser Photocoagulation Treatment.

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Diabetic Eye Problems Edema Retinal Disorders

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:

Best corrected visual acuity after 12 months of single intravitreal injection of triamcinolone acetonide. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Macular thickness measured by optical coherence tomography (OCT) after 12 months of treatment. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Safety of intravitreal triamcinolone acetonide after 12 months of treatment. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	October 2006
Estimated Study Completion Date:	August 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Intravitreal injection

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407849

Locations

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

Sponsors and Collaborators

Federal University of São Paulo

Investigators

Principal Investigator:

Jose A Cardillo, M.D

Federal University of Sao Paulo

More Information

Publications:

Martidis A, Duker JS, Greenberg PB, Rogers AH, Puliafito CA, Reichel E, Baumal C. Intravitreal triamcinolone for refractory diabetic macular edema. Ophthalmology. 2002 May;109(5):920-7.

Massin P, Audren F, Haouchine B, Erginay A, Bergmann JF, Benosman R, Caulin C, Gaudric A. Intravitreal triamcinolone acetonide for diabetic diffuse macular edema: preliminary results of a prospective controlled trial. Ophthalmology. 2004 Feb;111(2):218-24; discussion 224-5.

Gillies MC, Sutter FK, Simpson JM, Larsson J, Ali H, Zhu M. Intravitreal triamcinolone for refractory diabetic macular edema: two-year results of a double-masked, placebo-controlled, randomized clinical trial. Ophthalmology. 2006 Sep;113(9):1533-8. Epub 2006 Jul 7.

Responsible Party:	Vision Institute Department of Ophthalmology ( Federal University of Sao Paulo )
Study ID Numbers:	RETAAC001
Study First Received:	December 4, 2006
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00407849 History of Changes
Health Authority:	Brazil: National Committee of Ethics in Research; Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Triamcinolone hexacetonide
Diabetic Angiopathies
Macular Edema
Triamcinolone Acetonide
Therapeutic Uses
Triamcinolone
Cardiovascular Diseases
Diabetes Complications

Retinal Diseases
Eye Diseases
Diabetes Mellitus
Vascular Diseases
Retinal Degeneration
Macular Degeneration
Endocrine System Diseases
Enzyme Inhibitors
Triamcinolone diacetate
Glucocorticoids
Immunosuppressive Agents
Pharmacologic Actions
Diabetic Retinopathy

ClinicalTrials.gov processed this record on March 18, 2010