Study Comparing 0.5mg of Ranibizumab and Higher Doses in the Treatment of Clinically Significant Diabetic Macular Edema
Phase 1
Completed
- Conditions
- Clinically Significant Diabetic Macular Edema
- Interventions
- Registration Number
- NCT00440609
- Lead Sponsor
- Philip J. ferrone, M.D.
- 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 patients receiving 0.5mg Ranibizumab and higher doses of 1.0mg and 2.0mg Ranibizumab.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 0.5mg transitioning to 2.0mg ranibizumab Ranibizumab-intravitreal injection 1.0 mg transitioning to 2.0mg ranibizumab Ranibizumab-intravitreal injection
- Primary Outcome Measures
Name Time Method To evaluate safety and tolerability of ranibizumab in patients with clinically significant diabetic macular edema month 12 To compare the treatment of clinically significant diabetic macular edema with 0.5 mg of ranibizumab to 1.0 mg ranibizumab month 12
- Secondary Outcome Measures
Name Time Method Mean change in visual acuity as measured by ETDRS from baseline to month 12, 24 36,48 and 60 in each arm. month 12, 24, 36, 48 and 60 Mean change in central retinal thickness on OCT from baseline to month 12, 24, 36, 48 and 60 in each arm month 12, 24, 36,48 and 60 Changes observed on the fluorescein angiogram in each arm Month 60 Mean number of ranibizumab injections required in each arm Month 60 The need for "rescue therapy" with laser in each arm Month 60 Evaluate the efficacy and safety of ranibizumab in the fellow eye in the sub-group of patients who require treatment for clinically significant diabetic macular edema in the fellow eye Month 60
Trial Locations
- Locations (1)
Long Island Vitreoretinal Consultants
🇺🇸Hauppauge, New York, United States