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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT01581151
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent form
* 18 to 90 year-old men or women
* Women must be postmenopausal for at least 12 months before study enrollment, or surgically sterile. Potential child bearing women must have a negative serum pregnancy test within 14 days prior to the first treatment and practice effective contraception during and at least 120 days following the last dose of injection.
* Patient of the Wills Eye Institute Retina service, including all Mid-Atlantic Retina offices.
* Healthy enough to participate in the study.
* Willing and able to consent to participation in the study.
* Retinal vein occlusion:
* Must be diagnosed within two weeks of onset of symptoms
* Best Corrected Visual Acuity (BCVA) on initial presentation between 20/40 and 20/320
* No contraindications to intravitreal injection of dexamethasone implant or ranibizumab
* Central foveal thickness greater than 250 m on Spectral Domain-OCT
Exclusion Criteria:
* Unknown duration of symptoms prior to diagnosis.
* Patients with any history of prior intravitreal dexamethasone or anti-VEGF or grid laser.
* Patients with diabetic retinopathy.
* Patients with age-related macular degeneration.
* Patients with an optic neuropathy.
* Patients with a retinal detachment or history of retinal detachment.
* Patients with a significant epiretinal membrane.
* Patients with a history of choroidal neovascularization.
* Patients with glaucoma with visual field loss documented on a Humphrey Visual Field test or ocular hypertension requiring more than 2 medications to control IOP in the study eye.
* Patients with a clinically significant media opacity.
* Patients using or anticipating using systemic steroids.
* Patients with any uncontrolled systemic disease.
* Patients with aphakia or anterior-chamber intraocular lens.
* Patients with active neovascularization of the iris, disc, or retina.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01581151
Study Brief:
Protocol Section:
NCT01581151