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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Philip J. ferrone, M.D.
• Treatments: Ranibizumab

Criteria

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