Intravitreal Triamcinolone Acetonide for Treatment of Refractory Diffuse Diabetic Macular Edema

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00407849
• Other study ID #: RETAAC001
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: December 4, 2006
• Last updated: May 6, 2008
• Start date: October 2006
• Est. completion date: August 2008

Study information

• Verified date: May 2008
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in ResearchBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: August 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Macular Edema

Intervention

Drug:
• triamcinolone acetonide
Intravitreal injection

Locations

Country	Name	City	State
Brazil	Vision Institute, Federal University of Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best corrected visual acuity after 12 months of single intravitreal injection of triamcinolone acetonide.		12 months	No
Primary	Macular thickness measured by optical coherence tomography (OCT) after 12 months of treatment.		12 months	No
Primary	Safety of intravitreal triamcinolone acetonide after 12 months of treatment.		12 months	Yes