Back to resultsA Study of MK0140 in Diabetic Patients With Macular Edema (0140-001)
Primary Purpose
Macular Edema
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
triamcinolone acetonide
Sponsored by
About this trial
This is an interventional treatment trial for Macular Edema
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
1
2
3
4
Arm Description
100 mcg triamcinolone acetonide
500 mcg triamcinolone acetonide
925 mcg triamcinolone acetonide
sham control - not implanted, no medication
Outcomes
Primary Outcome Measures
Change from baseline in OCT retinal thickness; evaluate the safety and tolerability of doses.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00692614
Brief Title
A Study of MK0140 in Diabetic Patients With Macular Edema (0140-001)
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Study Start Date
June 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
100 mcg triamcinolone acetonide
Arm Title
2
Arm Type
Experimental
Arm Description
500 mcg triamcinolone acetonide
Arm Title
3
Arm Type
Experimental
Arm Description
925 mcg triamcinolone acetonide
Arm Title
4
Arm Type
No Intervention
Arm Description
sham control - not implanted, no medication
Intervention Type
Drug
Intervention Name(s)
triamcinolone acetonide
Other Intervention Name(s)
MK0140
Intervention Description
100 mcg; 500 mcg; 925 mcg triamcinolone acetonide on helical coil implant to elute over 12 months.
Primary Outcome Measure Information:
Title
Change from baseline in OCT retinal thickness; evaluate the safety and tolerability of doses.
Time Frame
After 12 months of therapy.
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study of MK0140 in Diabetic Patients With Macular Edema (0140-001)
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