A Study of MK0140 in Diabetic Patients With Macular Edema

This study has been terminated.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00692614
First received: June 4, 2008
Last updated: September 25, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Macular Edema
Drug: triamcinolone acetonide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change from baseline in OCT retinal thickness; evaluate the safety and tolerability of doses. [ Time Frame: After 12 months of therapy. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: After 12 months of therapy. ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
100 mcg triamcinolone acetonide
Drug: triamcinolone acetonide
100 mcg; 500 mcg; 925 mcg triamcinolone acetonide on helical coil implant to elute over 12 months.
Other Name: MK0140
Experimental: 2
500 mcg triamcinolone acetonide
Drug: triamcinolone acetonide
100 mcg; 500 mcg; 925 mcg triamcinolone acetonide on helical coil implant to elute over 12 months.
Other Name: MK0140
Experimental: 3
925 mcg triamcinolone acetonide
Drug: triamcinolone acetonide
100 mcg; 500 mcg; 925 mcg triamcinolone acetonide on helical coil implant to elute over 12 months.
Other Name: MK0140
No Intervention: 4
sham control - not implanted, no medication

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692614

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00692614     History of Changes
Other Study ID Numbers: 2008_521, MK0140-001
Study First Received: June 4, 2008
Last Updated: September 25, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014