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 @ 11:52 AM
Ignite Modification Date:
2025-12-24 @ 11:52 AM
NCT ID:
NCT01535261
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients ≥ 18 years of age
* Diagnosis of visual impairment exclusively due to ME secondary to CRVO
* BCVA score at Screening and Baseline between 73 and 19 letters Early Treatment Diabetic Retinopathy Study (ETDRS), inclusively (approximate Snellen chart equivalent of 20/40 and 20/400)
Exclusion Criteria:
* Uncontrolled blood pressure defined as systolic value of \> 160 mm Hg or diastolic value of \> 100 mm Hg at Screening or Baseline.
* Any active periocular or ocular infection or inflammation at Screening or Baseline in either eye
* Uncontrolled glaucoma at Screening or Baseline or diagnosed within 6 months before Baseline in either eye
* Use of any systemic antivascular endothelial growth factor (anti-VEGF) drugs within 6 months before Baseline (eg, sorafenib \[Nexavar®\], sunitinib \[Sutent®\], bevacizumab \[Avastin®\])
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01535261
Study Brief:
Protocol Section:
NCT01535261