This study will evaluate the treatment effect of three doses of the I-vation TA implant (MK0140) in diabetic patients with clinically significant macular edema.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2
100 mcg; 500 mcg; 925 mcg triamcinolone acetonide on helical coil implant to elute over 12 months.
Change from baseline in OCT retinal thickness; evaluate the safety and tolerability of doses.
Time frame: After 12 months of therapy.
Evaluation of visual acuity; change from baseline in OCT center-point retinal thickness; the need for focal/grid laser photocoagulation during the study; the progression of diabetic retinopathy
Time frame: After 12 months of therapy.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.