Intravitreal Triamcinolone Acetonide for Treatment of Refractory Diffuse Diabetic Macular Edema

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Federal University of São Paulo.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00407849
First received: December 4, 2006
Last updated: May 6, 2008
Last verified: May 2008
  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 1
Phase 2

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:


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:
    Drug: triamcinolone acetonide
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional relevant MeSH terms:
Macular Edema
Diabetic Retinopathy
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Triamcinolone hexacetonide
Triamcinolone Acetonide
Triamcinolone
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014