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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Intravitreal injection
Vision Institute, Federal University of Sao Paulo
São Paulo, São Paulo, Brazil
Best corrected visual acuity after 12 months of single intravitreal injection of triamcinolone acetonide.
Time frame: 12 months
Macular thickness measured by optical coherence tomography (OCT) after 12 months of treatment.
Time frame: 12 months
Safety of intravitreal triamcinolone acetonide after 12 months of treatment.
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.