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:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2025-12-24 @ 2:15 PM
NCT ID:
NCT01175395
Eligibility Criteria:
Inclusion Criteria:
1. Male or Female subjects, 55 years of age and older.
2. Diagnosis of active, subfoveal choroidal neovascular membranes (CNVM) due to age related macular degeneration (AMD)
3. Visual acuity from 20/25 to 20/400 in the study eye.
Exclusion Criteria:
1. Subjects who have received corticosteroids via any route in the past 30 days.
2. In the opinion of the investigator, patient is known to be a steroid-responder.
3. Subjects with a history of uncontrolled glaucoma (Primary or Secondary)
4. History of ocular surgery (invasive or non-invasive) in the past 90 days
5. Intravitreal treatment with an anti-VEGF agent e.g. bevacizumab, ranibizumab, or pegaptanib within 30 days of the enrollment (Day 0) examination.
6. Patients requiring systemic steroids (greater than 15 mg daily by mouth) or systemic immunomodulatory agents.
7. Active ocular or periocular infection (i.e., bacterial, viral, parasitic or fungal) in either eye or a history of herpetic ocular infection in either eye.
8. Media opacity in the study eye precluding observation or photography of the fundus.
9. Any other clinically significant medical or psychological condition that, in the opinion of the Investigator, would jeopardize the safety of the patient or affect the validity of the study results.
10. Participation in a clinical trial of an investigational drug or device within 30 days of the screening visit.
11. Known history of allergy to corticosteroids.
12. Pregnant or lactating women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT01175395
Study Brief:
Protocol Section:
NCT01175395