NCT01845844

Ranibizumab For Persistent Diabetic Macular Edema After Bevacizumab

Ranibizumab For Persistent Diabetic Macular Edema After Bevacizumab (ROTATE Trial)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Southeast Retina Center, Georgia · 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 persistent Diabetic Macular Edema (DME) after recent and frequent bevacizumab (at least 2 bevacizumab intravitreal injections within 2 months prior to enrollment and at least 6 bevacizumab injections within 9 months of enrollment).

Detailed description

30 eyes will be randomized in a 1:2 ratio (Group A= 10 patients; Group B= 20 patients) Group A: ("monthly group")- Consented patient with enrolled eye will receive 12 monthly required injections of 0.3mg ranibizumab over 1 year OR Group B: ("As needed (PRN) Group")- Consented patient with enrolled eye will receive 6 monthly required injections of 0.3mg ranibizumab for 6 months, followed by as needed (PRN) dosing (required ranibizumab if DME persistent on Optical Coherence Tomography (OCT) and Early Treatment Diabetic Retina Study (ETDRS) Best Corrected Visual Acuity (BCVA) \<20/20) for 6 months.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Ranibizumab 0.3mg/0.05cc	Group A (Arm A) will receive monthly 0.3mg/0.05cc intravitreal injections for 12 consecutive months. Group B (Arm B) will receive monthly 0.3mg/0.05cc intravitreal injections for the first six months and then PRN for the remaining 6 months per protocol specified criteria.

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2013-05-03
• Last updated: 2014-09-17

Locations

1 site across 1 country: United States