Status:
COMPLETED
Study Comparing 0.5mg of Ranibizumab and Higher Doses in the Treatment of Clinically Significant Diabetic Macular Edema
Lead Sponsor:
Philip J. ferrone, M.D.
Conditions:
Clinically Significant Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of Ranibizumab in patients with Clinically Significant Diabetic Macular Edema (CSDME). It will also compare treatment outcomes for ...
Eligibility Criteria
Inclusion
- Type I or Type II diabetic subjects
- Vision between 20/20 and 20/400
- Presence of Clinically Significant Diabetic Macular Edema
Exclusion
- Presence of any condition that would prevent clear visualization of the back of the eye
- Uncontrolled glaucoma
- Complications of glaucoma
- Inflammation inside the eye
- Certain prior eye surgeries, other than cataract surgery
- Other eye diseases that may compromise the vision in the study eye
- Certain prior eye treatments
- Pregnancy
- Uncontrolled health conditions
- History of heart attack
- History of stroke
- Current participation in another investigational trial
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00440609
Start Date
March 1 2007
End Date
December 1 2012
Last Update
August 2 2013
Active Locations (2)
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1
Long Island Vitreoretinal Consultants
Great Neck, New York, United States, 11021
2
Long Island Vitreoretinal Consultants
Hauppauge, New York, United States, 11749