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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Best corrected visual acuity after 12 months of single intravitreal injection of triamcinolone acetonide.
Timeframe: 12 months
Macular thickness measured by optical coherence tomography (OCT) after 12 months of treatment.
Timeframe: 12 months
Safety of intravitreal triamcinolone acetonide after 12 months of treatment.
Timeframe: 12 months