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 @ 12:41 AM
Ignite Modification Date:
2025-12-25 @ 12:41 AM
NCT ID:
NCT02947867
Eligibility Criteria:
Inclusion Criteria:
Subjects meeting all of the following criteria will be considered for enrolment to the trial:
* Male or female ≥ 18 years
* IOP in the study eye ≤ 21mmHg
* Primary ischaemic CRVO or conversion to ischaemic CRVO in the study eye for no longer than 4 weeks
* Best-corrected visual acuity (BCVA) ETDRS letter score \< 35 (\< 20/200 Snellen equivalent) in the study eye
* ≥ 10-disc area of retinal capillary obliteration on fluorescein fundus angiography in the study eye (central fundus: macular area as defined by the optic disc and the arcades, an approximate 6000 micron circle around the fovea) and/or large, confluent retinal haemorrhages in the study eye
Must be accompanied by 4 or more out of 6 following criteria:
* A relative afferent pupillary defect (with a normal fellow eye)
* ≥ 10 cotton-wool-spots in the study eye
* Venous tortuosity in the study eye
* Peripheral visual field defects corresponding to ischaemia (Goldmann perimeter or other semi-automatic kinetic methods) in the study eye
* Engorged vessels on iris and/or in the chamber angle in the study eye
* Detectable anterior chamber flare in the study eye
Exclusion Criteria:
Subjects presenting 1 or more of the following criteria will not be enrolled in the trial:
* Ocular conditions with a poorer prognosis in the fellow eye than in the study eye
* Primary or secondary glaucoma in the study eye
* Prior or concomitant ocular treatment with anti-VEGF in the study eye (ranibizumab/bevacizumab is not allowed within the last 45 days, aflibercept within the last 90 days) before screening visit
* Use of anti-VEGF treatment in the fellow eye during the trial
* Previous use of intraocular corticosteroids at any time or use of periocular corticosteroids in the study eye within 90 days prior to screening visit
* History of idiopathic or autoimmune uveitis in either eye
* Presence of NVD, NVE or anterior segment neovascularisation (NVA or NVI) in the study eye
* Previous PRP in the study eye
* Intraocular surgery (other than intravitreal anti-VEGF treatment) or laser treatment in the study eye within the past 90 days before screening visit
* Patients with a history of breast cancer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02947867
Study Brief:
Protocol Section:
NCT02947867