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

NCT ID: NCT00692614

Last Updated: 2015-11-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2008-11-30

Brief 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.

Conditions

Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

100 mcg triamcinolone acetonide

Group Type: EXPERIMENTAL

triamcinolone acetonide

Intervention Type: DRUG

100 mcg; 500 mcg; 925 mcg triamcinolone acetonide on helical coil implant to elute over 12 months.

2

500 mcg triamcinolone acetonide

Group Type: EXPERIMENTAL

triamcinolone acetonide

Intervention Type: DRUG

100 mcg; 500 mcg; 925 mcg triamcinolone acetonide on helical coil implant to elute over 12 months.

3

925 mcg triamcinolone acetonide

Group Type: EXPERIMENTAL

triamcinolone acetonide

Intervention Type: DRUG

100 mcg; 500 mcg; 925 mcg triamcinolone acetonide on helical coil implant to elute over 12 months.

4

sham control - not implanted, no medication

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

triamcinolone acetonide

100 mcg; 500 mcg; 925 mcg triamcinolone acetonide on helical coil implant to elute over 12 months.

Intervention Type: DRUG

Other Intervention Names

MK0140

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

MK0140-001

Identifier Type: -

Identifier Source: secondary_id

2008_521

Identifier Type: -

Identifier Source: secondary_id

0140-001

Identifier Type: -

Identifier Source: org_study_id