NCT00407849

Intravitreal Triamcinolone Acetonide for Treatment of Refractory Diffuse Diabetic Macular Edema

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Retinopathy

Interventions

Type	Name	Description
DRUG	triamcinolone acetonide	Intravitreal injection

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-12-01
• Completion: 2008-08-01
• First posted: 2006-12-05
• Last updated: 2008-05-07

Locations

1 site across 1 country: Brazil