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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
0.5mg or 1.0mg intravitreal injection given monthly for 3 months then every other month if needed, for the first year.Patients may be treated monthly as needed. Patients in Cohort 1(the first 30 patients)will be eligible to receive treatment as needed with 2.0mg ranibizumab starting at month 24. Patients in Cohort 2(the remaining 20)will be eligible to receive treatment as needed with 2.0mg ranibizumab starting at month 12.Patients may receive 2.0mg ranibizumab for a period limited to 24 months following administration of the first 2.0mg dose. Patients completing 36 months will be eligible to be followed for an additional 24 months. Starting at Month 36, patients will be able to receive monthly, the assigned dose that they received/or could have received(if re-treatment criteria was met)at Month 35. 2/1/12 - the 2.0mg dose has been discontinued, all subjects will transition to the 0.5mg dose.
Long Island Vitreoretinal Consultants
Great Neck, New York, United States
Long Island Vitreoretinal Consultants
Hauppauge, New York, United States
To evaluate safety and tolerability of ranibizumab in patients with clinically significant diabetic macular edema
Time frame: month 12
To compare the treatment of clinically significant diabetic macular edema with 0.5 mg of ranibizumab to 1.0 mg ranibizumab
Time frame: month 12
Mean change in visual acuity as measured by ETDRS from baseline to month 12, 24 36,48 and 60 in each arm.
Time frame: 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
Time frame: month 12, 24, 36,48 and 60
Changes observed on the fluorescein angiogram in each arm
Time frame: Month 60
Mean number of ranibizumab injections required in each arm
Time frame: Month 60
The need for "rescue therapy" with laser in each arm
Time frame: 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
Time frame: Month 60
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