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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Macular Edema

Treatments: Drug: triamcinolone acetonide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00692614

2008_521

0140-001

MK0140-001

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2 participants in 4 patient groups

1

Experimental group

Description:

100 mcg triamcinolone acetonide

Treatment:

Drug: triamcinolone acetonide

2

Experimental group

Description:

500 mcg triamcinolone acetonide

Treatment:

Drug: triamcinolone acetonide

3

Experimental group

Description:

925 mcg triamcinolone acetonide

Treatment:

Drug: triamcinolone acetonide

4

No Intervention group

Description:

sham control - not implanted, no medication