Status:
COMPLETED
Pilot Study of Ranibizumab (Lucentis) for Uveitic Cystoid Macular Edema
Lead Sponsor:
University of Miami
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Uveitic Cystoid Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Uveitic Cystoid Macular Edema (CME) is a major cause of visual loss associated with uveitis. Systemic and/or local corticosteroid therapy and systemic immunosuppression with steroid-sparing agents suc...
Eligibility Criteria
Inclusion
- Subjects will be eligible if the following criteria are met:
- Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- Age \> 18 years
- Non-infectious uveitis in study eye.
- Stable anti-uveitis medical regimen for at least one month prior to injection and controlled uveitis in the judgment of the investigator.
- Vision 20/40 or worse in study eye.
- Cystoid Macular Edema (CME) on fluorescein angiography (FA)
- Optical Coherence Tomography (OCT) demonstrating thickness greater than 300 microns in the central subfield.
- Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography.
- Only one eye will be assessed in the study. If both eyes are eligible, the investigator will determine which eye will be entered into the study.
Exclusion
- Previous intravitreal triamcinolone injection in study eye within 3 months of study injection.
- Use of more than two glaucoma medicines for study eye.
- Significant epiretinal membrane as judged by treating physician.
- Evidence of vitreomacular traction on OCT.
- Previous vitrectomy in study eye.
- 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 intrauterine device (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 IND trial.
- Treatment for CME with intravitreal Lucentis, Macugen, or Avastin within 6 weeks prior to enrollment in this study.
- Uncontrolled inflammation in the study eye.
- Current vitreous hemorrhage.
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
- Known allergy to any component of the study drug.
- Intraocular pressure \> 25 mm Hg despite treatment with glaucoma medications.
- Blood pressure \> 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, the subject can become eligible.
- Major non-ocular surgery planned during the next 6 months.
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
- No Avastin use permitted in fellow eye during study.
- Unwilling or unable to follow or comply with all study related procedures
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00826618
Start Date
June 1 2008
End Date
September 1 2013
Last Update
August 26 2014
Active Locations (2)
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1
Bascom Palmer Eye Insitute
Miami, Florida, United States, 33136
2
Bascom Palmer of the Palm Beaches
Palm Beach Gardens, Florida, United States, 33418