Status:
UNKNOWN
Ranibizumab For Persistent Diabetic Macular Edema After Bevacizumab
Lead Sponsor:
Southeast Retina Center, Georgia
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 beva...
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....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01845844
Start Date
April 1 2013
End Date
January 1 2015
Last Update
September 17 2014
Active Locations (1)
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1
Southeast Retina Center, PC
Augusta, Georgia, United States, 30909