Status:
UNKNOWN
Intravitreal Triamcinolone Acetonide for Treatment of Refractory Diffuse Diabetic Macular Edema
Lead Sponsor:
Federal University of São Paulo
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2008
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00407849
Start Date
October 1 2006
End Date
August 1 2008
Last Update
May 7 2008
Active Locations (1)
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1
Vision Institute, Federal University of Sao Paulo
São Paulo, São Paulo, Brazil, 04023-062