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 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT01247220
Eligibility Criteria:
Inclusion Criteria:
* 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
* Disease related considerations:
* Study eye with macular edema secondary to branch retinal vein occlusion characterized by:
* Fovea-involved macular edema of less than 12 months peripheral nonperfusion defined as at least 5 disc areas of contiguous nonperfusion on ultra-widefield fluorescein angiography absence of macular traction on clinical exam, UWFA, and OCT.
* Study eye with best corrected visual acuity between 20/40 (≤ 73 letters on ETDRS chart) and 20/320 (≥ 19 letters on ETDRS chart)
* Other considerations
* Patient able to complete all study visits
Exclusion Criteria:
* Subjects who meet any of the following criteria will be excluded from this study:
* 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 IUD, or contraceptive hormone implant or patch.
* Prior enrollment in the study
* 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 medical investigation or trial
* Therapy with intravitreal triamcinolone, pegaptanib, ranibizumab, or bevacizumab within the previous 3 months
* Previous macular or panretinal scatter laser photocoagulation
* Previous pars plana vitrectomy
* Visually-significant significant cataracts as primary reason for vision loss
* Myocardial infarction or cerebrovascular accident within 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01247220
Study Brief:
Protocol Section:
NCT01247220