Status:
WITHDRAWN
Study of Uveitic Macular Edema Treated With Ranibizumab or Steroids
Lead Sponsor:
University of Utah
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Macular Edema
Uveitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a pilot study to investigate the safety and efficacy of intravitreally administered ranibizumab (Lucentis) compared to steroid injection for the treatment of macular edema due to chronic non-i...
Detailed Description
This is a proof of concept study to assess the safety and potential efficacy of ranibizumab in this patient population. Since it is common clinical practice to perform regional periocular injections o...
Eligibility Criteria
Inclusion
- At least 18 years of age
- History of non-infectious uveitis w chronic cystoid macular edema
- Refractory to therapy w periocular steroids; Last periocular steroid injection a minimum of 3 months prior to study enrollment
- Currently using oral steroids (\< or = 10 mg/day) and/or steroid sparing agents
- BCVA between 20/40 and 20/400
- IOP between 5 mmHg and 30 mmHg
- Media clarity sufficient for OCT measurement
Exclusion
- Women known to be pregnant or have a positive urine pregnancy test; Pre-menopausal women not using adequate contraception during the study
- Prior treatment for CME with Macugen or Avastin in the study eye
- History of stroke
- Presence of vitreous hemorrhage or epiretinal membrane in the study eye
- Active infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye
- Presence or history of uncontrolled glaucoma
- Known allergy or hypersensitivity to any component of the study drug
- Major surgery planned during the next 6 months
- Simultaneous participation in another clinical investigation
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00846625
Start Date
November 1 2009
End Date
August 1 2011
Last Update
December 11 2014
Active Locations (1)
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1
John Moran Eye Center
Salt Lake City, Utah, United States, 84132