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 @ 9:46 PM
Ignite Modification Date:
2025-12-24 @ 9:46 PM
NCT ID:
NCT01571232
Eligibility Criteria:
Inclusion Criteria:
* Presence of NPDR or PDR as confirmed by fluorescein angiography
* Prior treatment with \>= 2 intravitreal anti-VEGF injections but no treatment in last 4 weeks
* \< 0.1 LogOCT decrease in macular edema on high resolution OCT between initial visit and following treatment with \>= 2 intravitreal anti-VEGF injections
* Age 18 years or older
* ETDRS Visual acuity between 3 and 78 letters (approximate Snellen equivalent of 20/25 to 20/800)
* Ability to provide written informed consent
* Capable of complying with study protocol.
Exclusion Criteria:
* Intraocular injection of steroid medication within prior 3 months
* Evidence of significant geographic atrophy on fluorescein angiography in the opinion of the treating physician
* Concurrent ocular disease (wet AMD, significant ERM, etc) that would limit visual acuity in the opinion of the treating physician
* Prior vitrectomy surgery
* Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month prior to day 1.
* Known history of IOP elevation in response to steroid treatment in either eye that resulted in any of the following: a) = 10 mm Hg increase in IOP in response to steroid injection, or b) IOP = 25 mm Hg and required 2 or more anti-glaucoma medications to keep IOP below 21 mm Hg.
* Patients who are pregnant.
* Unwilling or unable to follow or comply with all study related procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01571232
Study Brief:
Protocol Section:
NCT01571232