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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00692614
First Posted: June 6, 2008
Last Update Posted: November 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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. ]

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. ]

Enrollment: 2
Study Start Date: June 2008
Study Completion Date: November 2008
Primary Completion Date: November 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00692614


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00692614     History of Changes
Other Study ID Numbers: 0140-001
MK0140-001
2008_521
First Submitted: June 4, 2008
First Posted: June 6, 2008
Last Update Posted: November 2, 2015
Last Verified: October 2015

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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action