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 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT00457067
Eligibility Criteria:
* INCLUSION CRITERIA:
1. Participant must understand and sign the informed consent.
2. Participant must be at least 18 years of age.
3. Participant must have macular telangiectasia in both eyes.
4. Participant must have neovascularization in the study eye.
5. Participant must have vision loss of 20/40 or worse.
6. Participant must have clear ocular media and adequate papillary dilation to permit good quality stereoscopic fundus photography.
7. All women of childbearing potential must have a negative urine pregnancy test at baseline, and be willing to undergo testing immediately prior to each injection and monthly for at least 2 months following the last dose of ranibizumab.
8. Women of child-bearing potential who are sexually active and men who are sexually active are required to use two forms of birth control during the course of the study.
EXCLUSION CRITERIA:
1. History (within past 5 years) or evidence of severe cardiac disease (apparent in electrocardiogram abnormalities, clinical history of unstable angina, acute coronary syndrome, myocardial infarction, revascularization procedure within 6 months prior to baseline, atrial or ventricular tachyarrythmias requiring ongoing treatment).
2. History of stroke within 12 months of study entry.
3. History within the past five years of a chronic ocular or periocular infection (including any history of ocular herpes zoster).
4. Current acute ocular or periocular infection.
5. Any major surgical procedure within one month of study entry.
6. Known serious allergies to fluorescein dye.
7. Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, bevacizumab, anecortave acetate, Protein Kinase C inhibitors, etc.).
8. Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye.
9. History of vitrectomy surgery in the study eye.
10. History of glaucoma filtering surgery in the study eye.
11. History of corneal transplant in the study eye.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00457067
Study Brief:
Protocol Section:
NCT00457067