A Study of MK0140 in Diabetic Patients With Macular Edema (0140-001)

A Phase IIb, Randomized, Masked, Sham-Controlled, Clinical Trial to Study the Efficacy and Safety of the Helical Triamcinolone Acetonide Implant (MK0140) in Diabetic Patients With Clinically Significant Macular Edema

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.

Inclusion Criteria:

• Patient has clinically significant macular edema as a result of their diabetes (Type I or Type 2)
• Patient has in the study eye, 20/40 - 20/160 vision
• Patient has Type 1 or Type 2 diabetes
• Patient agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control

Exclusion Criteria:

• Patient has had any active ocular infection in either eye
• Patient has intraocular pressure > 22 mmHg or a diagnosis of glaucoma
• Patient has cystoid macular edema in the study eye
• Patient has a history of elevated IOP in response to ocular steroid therapy in either eye
• Patient has had intraocular surgery in the study eye within 6 months prior to Visit 1
• Patient has an HbAIc value > 10% at Visit 1
• Patient has within the last 4 months initiated intensive insulin treatment or plan to do so in the next 4 months
• Patient has a history of cancer within 5 years prior to signing informed consent
• Patient has clinically-relevant chronic renal failure
• Patient has high blood pressure
• Patient has coronary heart disease
• Patient has known allergies to steroids