NCT02448446

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: South Coast Retina Center; Carson, McBeath, Boswell, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabetic Macular Edema
• Hard Lipid Exudates

Interventions

Type	Name	Description
DRUG	ranibizumab 0.3mg	intravitreally administered

Timeline

• Start date: 2015-08-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2015-05-19
• Last updated: 2021-07-08
• Results posted: 2021-07-08

Locations

4 sites across 1 country: United States