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

Diabetic Macular Edema Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Hard Lipid Exudates
• Macular Edema

• NCT number: NCT02448446
• Study type: Interventional
• Source: South Coast Retina Center; Carson, McBeath, Boswell, Inc.
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 2015
• Completion date: May 2018