NCT02127684

Frequent Dosing Regimen of Lucentis for Subjects With Persistent Diabetic Macular Edema Despite Standard antiVEGF Dosing

Frequent Dosing Regimen of Lucentis for Subjects With Persistent Diabetic Macular Edema Despite Standard AntiVEGF Dosing

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Maturi, Raj K., M.D., P.C. · Individual
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators would like to investigate the efficacy of more frequent treatment with Lucentis for subjects with persistent diabetic macular edema despite standard dosing regimen.

Detailed description

This is an open-label, subject masked, phase II study of intravitreally administered ranibizumab in subjects with persistent diabetic macular edema. Persistent diabetic macular edema is defined as subjects who still have central subfield thickness on SD-OCT of greater than 320 microns after having received at least 3 previous doses of AntiVEGF therapy in the past 5 months. Consented, enrolled subjects will be randomized into two subgroups: (1) standard dosing of monthly 0.3mg ranibizumab or (2) 0.3mg ranibizumab given 2 weeks apart for 5 doses followed by monthly dosing.

Conditions

• Persistent Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	ranibizumab	ranibizumab 0.3mg intravitreally monthly
DRUG	ranibizumab	ranibizumab given every 2 weeks for 8 weeks then monthly as needed

Timeline

• Primary completion: 2015-08-01
• Completion: 2015-11-01
• First posted: 2014-05-01
• Last updated: 2014-07-30

Locations

1 site across 1 country: United States