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Intravitreal Triamcinolone Acetonide for Treatment of Refractory Diffuse Diabetic Macular Edema

Information source: Federal University of São Paulo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetic Retinopathy

Intervention: triamcinolone acetonide (Drug)

Phase: Phase 1/Phase 2

Status: Active, not recruiting

Sponsored by: Federal University of São Paulo

Official(s) and/or principal investigator(s):
Jose A Cardillo, M.D, Principal Investigator, Affiliation: Federal University of Sao Paulo

Summary

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Best corrected visual acuity after 12 months of single intravitreal injection of triamcinolone acetonide.

Macular thickness measured by optical coherence tomography (OCT) after 12 months of treatment.

Safety of intravitreal triamcinolone acetonide after 12 months of treatment.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

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

Related 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.

Starting date: October 2006
Last updated: May 6, 2008

Page last updated: August 23, 2015

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