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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Macular Edema

Intervention / Treatment
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* Drug: triamcinolone acetonide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>100 mcg triamcinolone acetonide | Drug: triamcinolone acetonide<br>* 100 mcg; 500 mcg; 925 mcg triamcinolone acetonide on helical coil implant to elute over 12 months.<br>* Other names: MK0140;|
| Experimental: 2<br>500 mcg triamcinolone acetonide | Drug: triamcinolone acetonide<br>* 100 mcg; 500 mcg; 925 mcg triamcinolone acetonide on helical coil implant to elute over 12 months.<br>* Other names: MK0140;|
| Experimental: 3<br>925 mcg triamcinolone acetonide | Drug: triamcinolone acetonide<br>* 100 mcg; 500 mcg; 925 mcg triamcinolone acetonide on helical coil implant to elute over 12 months.<br>* Other names: MK0140;|
| No Intervention: 4<br>sham control - not implanted, no medication | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in OCT retinal thickness; evaluate the safety and tolerability of doses. |  | After 12 months of therapy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | After 12 months of therapy. |