The Effect of Intravitreal Ranibizumab on Visual Acuity and Hard Exudate Resolution in the Treatment of Diabetic Macular Edema With Center Involved Edema and Lipid Exudates

Phase 1

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Diabetic macular edema treatment group (Group 1)	ranibizumab 0.3mg	Treatment using intravitreal ranibizumab 0.3mg based on the DRCR protocol I 4:2:7 strategy based on the presence of macular edema.
Diabetic macular edema and lipid treatment group (Group 2)	ranibizumab 0.3mg	Continued treatment with intravitreal ranibizumab 0.3mg until, not only the macular edema is resolved, but also until the lipid exudate is resolved.

Primary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity as Measured by ETDRS at 6 and 12 Months	6-12 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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Eyes With Complete Resolution of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography	12 months
Incidence and Severity of Ocular Adverse Events as a Measure of Safety and Tolerability	12 months
Percentage of Eyes With Improvement of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography	12 months
Number of Eyes With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography	12 months
Incidence and Severity of Other Adverse Events as a Measure of Safety and Tolerability	12 months
Number of Eyes With Complete Resolution in the Central Subfield as Measured on OCT and Fundus Photography	12 months
Percentage of Patients With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured on OCT and Fundus Photography	12 months
Percentage of Eyes With Improvement in Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography	12 months

Locations (3): South Coast Retina Center; Carson, McBeath, and Boswell, Inc
🇺🇸
Long Beach, California, United States
South Coast Retina Center; Carson, McBeath, Boswell, Inc
🇺🇸
Torrance, California, United States
Retina Partners
🇺🇸
Santa Monica, California, United States