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 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
NCT ID:
NCT01599650
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent must be obtained before any study assessment is performed
* Diagnosis of visual impairment exclusively due to ME secondary to BRVO
* BCVA score at Screening and Baseline between 73 and 19 letters (ETDRS)
Exclusion Criteria:
* Pregnant or nursing (lactating) women
* Stroke or myocardial infarction less than 3 months before Screening
* 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
* Neovascularization of the iris or neovascular glaucoma in the study eye
* Use of any systemic antivascular endothelial growth factor (anti-VEGF) drugs within 6 months before Baseline
* Panretinal laser photocoagulation within 3 months before Baseline or anticipated or scheduled within the next 3 months following Baseline in the study eye
* Focal or grid laser photocoagulation within 4 months before Baseline in the study eye
* Use of intra- or periocular corticosteroids (including sub-Tenon) within 3 months before Screening in the study eye
* Any use of intraocular corticosteroid implants (eg, dexamethasone \[Ozurdex®\], fluocinolone acetonide \[Iluvien®\]) in the study eye
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01599650
Study Brief:
Protocol Section:
NCT01599650