Status:
COMPLETED
Dosing Study of Ranibizumab for Diabetic Retinal and Macular Edema
Lead Sponsor:
Retina Vitreous Associates of Florida
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Diabetic Retinopathy
Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is to see whether treating diabetic retinal swelling with ranibizumab injections into the eye monthly is better than treating diabetic retinal swelling with ranibizumab injections into the ...
Detailed Description
This is a prospective randomized study comparing two groups of patients with diabetic macular edema. One group will receive injections of ranibizumab monthly and the other group will have the option t...
Eligibility Criteria
Inclusion
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age \> 18 years
- Patient related considerations
- Phakic or pseudophakic patients with a known history of diabetes will be eligible.
- Women of reproductive age will be required to take a urine pregnancy test prior to administration of the study drug.
- Disease related considerations:
- Patients will have met standard, accepted diagnostic criteria for diabetes and will be currently treated with at least one systemic antihyperglycemic or insulin medication.
- Patients will have a BCVA ETDRS Snellen-equivalent less than or equal to 20/40
- Central foveal thickness on SD-OCT of \>300um
Exclusion
- Pregnancy (positive pregnancy test) or lactation Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial
- Foveal ischemia on IVFA
- Intraocular surgery less than 6 months ago
- Epiretinal membrane of clinical significance
- Prior vitrectomy
- Uncontrolled glaucoma
- Macular or peripheral laser within 90 Days from Day 0 injection
- Intravitreal steroid injection within 90 days from Day 0 injection
- Intravitreal or systemic anti-VEGF within 30 days from Day 0 injection
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01476449
Start Date
November 1 2011
End Date
September 1 2016
Last Update
May 17 2019
Active Locations (2)
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1
Retina Vitreous Associates of Florida
Clearwater, Florida, United States, 33756
2
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States, 33711