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

NCT00692614 | Terminated Phase 2

• 3 other identifiers: 0140-001MK0140-0012008_521
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in OCT retinal thickness; evaluate the safety and tolerability of doses.

  After 12 months of therapy.

Secondary Outcomes (1)

• 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

  After 12 months of therapy.

Study Arms (4)

1

EXPERIMENTAL

100 mcg triamcinolone acetonide

Drug: triamcinolone acetonide

2

EXPERIMENTAL

500 mcg triamcinolone acetonide

Drug: triamcinolone acetonide

3

EXPERIMENTAL

925 mcg triamcinolone acetonide

Drug: triamcinolone acetonide

4

NO INTERVENTION

sham control - not implanted, no medication

Interventions

triamcinolone acetonide DRUG

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

Also known as: MK0140

1; 2; 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Macular Edema

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2008
• First Posted: June 6, 2008
• Study Start: June 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: November 2, 2015

Record last verified: 2015-10