Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:47 AM
Ignite Modification Date:
2025-12-25 @ 4:47 AM
NCT ID:
NCT00826618
Eligibility Criteria:
Inclusion Criteria:
Subjects will be eligible if the following criteria are met:
1. Ability to provide written informed consent and comply with study assessments for the full duration of the study.
2. Age \> 18 years
3. Non-infectious uveitis in study eye.
4. Stable anti-uveitis medical regimen for at least one month prior to injection and controlled uveitis in the judgment of the investigator.
5. Vision 20/40 or worse in study eye.
6. Cystoid Macular Edema (CME) on fluorescein angiography (FA)
7. Optical Coherence Tomography (OCT) demonstrating thickness greater than 300 microns in the central subfield.
8. 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 Criteria:
1. Previous intravitreal triamcinolone injection in study eye within 3 months of study injection.
2. Use of more than two glaucoma medicines for study eye.
3. Significant epiretinal membrane as judged by treating physician.
4. Evidence of vitreomacular traction on OCT.
5. Previous vitrectomy in study eye.
6. Pregnancy (positive pregnancy test) or lactation.
7. 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.
8. Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
9. Participation in another simultaneous IND trial.
10. Treatment for CME with intravitreal Lucentis, Macugen, or Avastin within 6 weeks prior to enrollment in this study.
11. Uncontrolled inflammation in the study eye.
12. Current vitreous hemorrhage.
13. Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
14. Known allergy to any component of the study drug.
15. Intraocular pressure \> 25 mm Hg despite treatment with glaucoma medications.
16. 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.
17. Major non-ocular surgery planned during the next 6 months.
18. Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
19. No Avastin use permitted in fellow eye during study.
20. Unwilling or unable to follow or comply with all study related procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00826618
Study Brief:
Protocol Section:
NCT00826618