This is an open-label, Phase I/II study of intravitreally administered 0.3mg ranibizumab in subjects with diabetic macular edema and lipid exudates in the central subfield.
This is an open-label, Phase I/II study of intravitreally administered 0.3mg ranibizumab in subjects with diabetic macular edema and lipid exudates in the central subfield. Consented, enrolled subjects will receive multiple open-label intravitreal injections on 0.3mg ranibizumab administered every 30 days for 12 months per the treatment algorithm. The patients will be randomized to 1 of 2 treatment groups. Group 1: Treatment algorithm based on the Diabetic Retinopathy Clinical Research (DRCR) protocol I 4:2:7 strategy based on the presence of macular edema. Group 2: Continue treatment until not only the macular edema is resolved but also until the lipid exudate is resolved. Sample size: 30 eyes Follow-up Schedule: Every 4 weeks throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
intravitreally administered
South Coast Retina Center; Carson, McBeath, Boswell, Inc
Huntington Beach, California, United States
South Coast Retina Center; Carson, McBeath, and Boswell, Inc
Long Beach, California, United States
Retina Partners
Santa Monica, California, United States
South Coast Retina Center; Carson, McBeath, Boswell, Inc
Torrance, California, United States
Best Corrected Visual Acuity as Measured by ETDRS at 6 and 12 Months
Compare Group 1 and Group 2 for best correct visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters.
Time frame: 6-12 months
Percentage of Eyes With Improvement of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography
Time frame: 12 months
Percentage of Eyes With Complete Resolution of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography
Time frame: 12 months
Number of Eyes With Complete Resolution in the Central Subfield as Measured on OCT and Fundus Photography
Time frame: 12 months
Percentage of Eyes With Improvement in Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography
Time frame: 12 months
Percentage of Patients With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured on OCT and Fundus Photography
Time frame: 12 months
Number of Eyes With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography
Time frame: 12 months
Incidence and Severity of Ocular Adverse Events as a Measure of Safety and Tolerability
Time frame: 12 months
Incidence and Severity of Other Adverse Events as a Measure of Safety and Tolerability
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Time frame: 12 months