Study Comparing 0.5mg of Ranibizumab and Higher Doses in the Treatment of Clinically Significant Diabetic Macular Edema



Status:Completed
Conditions:Cardiology, Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:10/26/2017
Start Date:March 2007
End Date:December 2012

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A Phase I/II Study Comparing the Treatment of Clinically Significant Diabetic Macular Edema (CSDME) With 0.5mg Ranibizumab, 1.0mg Ranibizumab and 2.0mg Ranibizumab

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 patients receiving 0.5mg Ranibizumab and higher doses of 1.0mg and
2.0mg Ranibizumab.


Inclusion Criteria:

- Type I or Type II diabetic subjects

- Vision between 20/20 and 20/400

- Presence of Clinically Significant Diabetic Macular Edema

Exclusion Criteria:

- 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
We found this trial at
2
sites
Hauppauge, New York 11788
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Hauppauge, NY
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Great Neck, New York 11021
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Great Neck, NY
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