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
Recruitment status was Active, not recruiting
Sponsor:
Federal University of São Paulo
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
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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:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
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:
-
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
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:
|
Diabetic Retinopathy Macular Edema Retinal Diseases Eye Diseases Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Macular Degeneration Retinal Degeneration Triamcinolone hexacetonide Triamcinolone |
Triamcinolone Acetonide 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 May 23, 2013