Study Comparing 0.5mg of Ranibizumab and Higher Doses in the Treatment of Clinically Significant Diabetic Macular Edema
Information source: Long Island Vitreoretinal Consultants
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Clinically Significant Diabetic Macular Edema
Intervention: ranibizumab (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Philip J. ferrone, M.D. Official(s) and/or principal investigator(s): Philip J. Ferrone, MD, Principal Investigator, Affiliation: Long Island Vitreoretinal Consultants
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: To evaluate safety and tolerability of ranibizumab in patients with clinically significant diabetic macular edemaTo compare the treatment of clinically significant diabetic macular edema with 0.5 mg of ranibizumab to 1.0 mg ranibizumab
Secondary outcome: Mean change in visual acuity as measured by ETDRS from baseline to month 12, 24 36,48 and 60 in each arm.Mean change in central retinal thickness on OCT from baseline to month 12, 24, 36, 48 and 60 in each arm Changes observed on the fluorescein angiogram in each arm Mean number of ranibizumab injections required in each arm The need for "rescue therapy" with laser in each arm 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Long Island Vitreoretinal Consultants, Great Neck, New York 11021, United States
Long Island Vitreoretinal Consultants, Hauppauge, New York 11749, United States
Additional Information
Starting date: March 2007
Last updated: August 1, 2013
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