Intravitreal Triamcinolone Acetonide for Treatment of Refractory Diffuse Diabetic Macular Edema
Information source: Federal University of São Paulo
Information obtained from ClinicalTrials.gov on June 20, 2008
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: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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
Ending date: August 2008
Last updated: May 6, 2008
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