- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00692614
A Study of MK0140 in Diabetic Patients With Macular Edema (0140-001)
October 30, 2015 updated by: Merck Sharp & Dohme LLC
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
100 mcg triamcinolone acetonide
|
100 mcg; 500 mcg; 925 mcg triamcinolone acetonide on helical coil implant to elute over 12 months.
Other Names:
|
Experimental: 2
500 mcg triamcinolone acetonide
|
100 mcg; 500 mcg; 925 mcg triamcinolone acetonide on helical coil implant to elute over 12 months.
Other Names:
|
Experimental: 3
925 mcg triamcinolone acetonide
|
100 mcg; 500 mcg; 925 mcg triamcinolone acetonide on helical coil implant to elute over 12 months.
Other Names:
|
No Intervention: 4
sham control - not implanted, no medication
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in OCT retinal thickness; evaluate the safety and tolerability of doses.
Time Frame: After 12 months of therapy.
|
After 12 months of therapy.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
After 12 months of therapy.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
November 1, 2008
Study Completion (Actual)
November 1, 2008
Study Registration Dates
First Submitted
June 4, 2008
First Submitted That Met QC Criteria
June 4, 2008
First Posted (Estimate)
June 6, 2008
Study Record Updates
Last Update Posted (Estimate)
November 1, 2015
Last Update Submitted That Met QC Criteria
October 30, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Macular Degeneration
- Macular Edema
- Edema
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Triamcinolone
- Triamcinolone Acetonide
- Triamcinolone hexacetonide
- Triamcinolone diacetate
Other Study ID Numbers
- 0140-001
- MK0140-001
- 2008_521
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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