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

• Status: Terminated
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

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