Ranibizumab For Persistent Diabetic Macular Edema After Bevacizumab

• Status: Unknown status
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Southeast Retina Center, Georgia
• Collaborator: Genentech, Inc.
• Treatments: Bevacizumab; Ranibizumab

Criteria

Inclusion Criteria:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study.

• >=18 years

• Type I/II diabetes mellitus

• Central-involved DME in study eye (OCT CSF >=275um on Heidelberg Spectralis spectral domain OCT with evidence of intraretinal or subretinal fluid or cysts)

• Definite retinal thickening due to diabetic macular edema involving the center of the macula.

• Media clarity, pupillary dilation and individual cooperation for adequate fungus photography and fluorescein angiography.

• Visual Acuity score in study eye <=80 and >=20 (approximate Snellen equivalent 20/25 to 20/400).

• History of at least 6 intravitreal bevacizumab injections within the past 9 months and 2 intravitreal bevacizumab injections within the past 2 months.

• No history of an anti-VEGF treatment for DME in the past 3 weeks.

• No other DME treatment for DME, other than bevacizumab, in the study eye at any time in the past 3 months.

• No history of major ocular surgery in the study eye within prior 3 months or anticipated within the next six months following randomization.

Exclusion Criteria:

• Pregnancy or lactation

• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated

• Participation in another medical investigation or trial within 30 days of randomization

• Known allergy to ranibizumab

• Acute cardiovascular event requiring hospitalization within the past 3 months

• Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomization or anticipated use during the study

• Macular edema is considered to be due to a cause other than DME

• An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from the resolution of macular edema

• History of intravitreal anti-vascular endothelial growth factor (anti-VEGF) agent other than bevacizumab within 9 months prior to randomization

• History of panretinal photocoagulation within 3 months prior to randomization or anticipated need for panretinal photocoagulation in the 6 months following randomization

• Yag capsulotomy performed within 1 month prior to randomization

• External ocular infection including conjunctivitis, significant blepharitis, etc.