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:
NCT00468351
Eligibility Criteria:
Inclusion Criteria:
* Refractory diffuse DME (defined herein as clinically significant DME \[by biomicroscopic evaluation\] unresponsive to focal laser photocoagulation \[performed at least 3 months before evaluation\] and generalized breakdown of the inner blood-retina barrier with diffuse fluorescein leakage involving the foveal center and most of the macular area on fluorescein angiography),
* Snellen logarithm of minimum angle of resolution (LogMAR) BCVA equivalent of 20/40 or worse, and 3) central macular thickness (CMT) greater than 300µm on optical coherence tomography (OCT)
Exclusion Criteria:
* Aphakic or pseudophakic eyes,
* Glycosylated hemoglobin (Hb A1C) rate above 10%,
* History of glaucoma or ocular hypertension,
* Loss of vision as a result of other causes,
* Systemic corticoid therapy,.
* History of thromboembolic event (including myocardial infarction or cerebral vascular accident);
* Major surgery within the prior 6 months or planned within the next 28 days;
* Uncontrolled hypertension (according to guidelines of the seventh report of the joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure \[JNC-7\]);16
* Known coagulation abnormalities or current use of anticoagulative medication other than aspirin;
* Severe systemic disease; or
* Any condition affecting follow-up or documentation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00468351
Study Brief:
Protocol Section:
NCT00468351