A Study of MK0140 in Diabetic Patients With Macular Edema (0140-001)
- Registration Number
- NCT00692614
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 triamcinolone acetonide 100 mcg triamcinolone acetonide 3 triamcinolone acetonide 925 mcg triamcinolone acetonide 2 triamcinolone acetonide 500 mcg triamcinolone acetonide
- Primary Outcome Measures
Name Time Method Change from baseline in OCT retinal thickness; evaluate the safety and tolerability of doses. After 12 months of therapy.
- Secondary Outcome Measures
Name Time Method 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.