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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT01231633
Eligibility Criteria:
Inclusion Criteria:
* Presence of central retinal vein occlusion (CRVO)
* Age 18 years or older
* ETDRS (Early Treatment Diabetic Retinopathy Study) Visual acuity between 3 and 72 letters and approximate Snellen equivalent of 20/40 to 20/800
* OCT Central foveal thickness \>250 microns
* Negative pregnancy test for women of childbearing potential
* Ability to provide written informed consent
* Capable of complying with study protocol
Exclusion Criteria:
* History of glaucoma in the study eye with intraocular pressure \>21mmHg on more than one topical medication. Combination drugs are considered more than one medication
* History of steroid-related glaucoma (steroid response)
* Previous intraocular injection of steroid medication within 90 days
* Avastin (bevacizumab) or Lucentis (ranibizumab) within 60 days
* Evidence of significant retinal ischemia on fluorescein angiography in the opinion of the treating physician
* Previous intraocular surgery (e.g. Cataract Surgery) with in 60 days
* Concurrent ocular disease that would limit visual acuity in the opinion of the treating physician
* Dense cataract that precludes clinical examination and retinal imaging of the retina
* History of allergy to dexamethasone, bevacizumab, betadine
* Ocular or systemic conditions that may pose a threat to the health of the subject in the opinion of the treating physician
* Unwilling or unable to follow or comply with all study related procedures
* Current participation in another clinical medical investigation or trial or has received any investigational drug within 12 weeks prior to enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01231633
Study Brief:
Protocol Section:
NCT01231633