Status:
TERMINATED
A Study of MK0140 in Diabetic Patients With Macular Edema (0140-001)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00692614
Start Date
June 1 2008
End Date
November 1 2008
Last Update
November 2 2015
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.