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Intravitreal Triamcinolone Acetonide for Treatment of Refractory Diffuse Diabetic Macular Edema

NCT ID: NCT00407849

Last Updated: 2008-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Retinopathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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triamcinolone acetonide

Intravitreal injection

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Vision Institute Department of Ophthalmology

Principal Investigators

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Jose A Cardillo, M.D

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

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Vision Institute, Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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. doi: 10.1016/s0161-6420(02)00975-2.

Reference Type BACKGROUND
PMID: 11986098 (View on PubMed)

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. doi: 10.1016/j.ophtha.2003.05.037.

Reference Type BACKGROUND
PMID: 15019365 (View on PubMed)

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. doi: 10.1016/j.ophtha.2006.02.065. Epub 2006 Jul 7.

Reference Type BACKGROUND
PMID: 16828501 (View on PubMed)

Other Identifiers

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RETAAC001

Identifier Type: -

Identifier Source: org_study_id