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 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT02870803
Eligibility Criteria:
Inclusion Criteria:
* Previous diagnosis of diabetes mellitus type 1 or 2;
* Age equal or greater than 18 years;
* At least one eye with diabetic macular edema and central thickness greater than or equal to 290 microns (female patients) or 305 microns (males) measured by OCT and subjected to intravitreal pharmacotherapy.
Exclusion Criteria:
* Aphakic patients;
* History of major eye surgeries (vitrectomy, cataract surgery, scleral buckle, other intraocular surgery) in the last 4 months;
* Tractional retinal detachment involving the macula, vitreomacular traction syndrome or other concurrent macular diseases;
* Advanced or uncontrolled glaucoma (according to the investigator's judgment); Evidence of angle neovascularization;
* Presence of an eye condition (besides diabetic retinopathy) which, in the opinion of the investigator, may alter the visual acuity during the study course (e.g. venous or arterial retinal occlusions, uveitis or other ocular inflammatory diseases, neovascular glaucoma, etc.);
* Significative cataract which, in the opinion of the investigator, may be decreasing visual acuity in 3 lines or more;
* History of YAG Laser capsulotomy in the last 2 months;
* Severe renal disease, defined as chronic renal failure requiring dialysis or a kidney transplant;
* Blood pressure higher than 180/110 mmHg, acute myocardial infarction, other acute cardiac events requiring hospitalisation, stroke, transient ischemic attack or treatment for congestive heart failure;
* Systemic treatment with anti-VEGF or pro-VEGF in the last 4 months.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02870803
Study Brief:
Protocol Section:
NCT02870803