Intravitreal Triamcinolone Acetonide for Treatment of Refractory Diffuse Diabetic Macular Edema

Sponsor

Federal University of São Paulo (Other)

Overall Status

Unknown status

CT.gov ID

NCT00407849

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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 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 or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy	Drug: triamcinolone acetonide	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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.

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Dec 1, 2007

Anticipated Study Completion Date :

Aug 1, 2008

Outcome Measures

Primary Outcome Measures

Best corrected visual acuity after 12 months of single intravitreal injection of triamcinolone acetonide. [12 months]
Macular thickness measured by optical coherence tomography (OCT) after 12 months of treatment. [12 months]
Safety of intravitreal triamcinolone acetonide after 12 months of treatment. [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.