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 @ 3:31 AM
Ignite Modification Date:
2025-12-25 @ 3:31 AM
NCT ID:
NCT04089605
Eligibility Criteria:
Inclusion Criteria:
* Age more than 18 years
* Glycosylated hemoglobin (HbA1c) less than 10.0%
* Best-corrected visual acuity (BCVA) between 20/400 to 20/40
* Central foveal thickness (CFT) more than 300 μm in the 1-mm central macular subfield on spectral domain optical coherence tomography (SD-OCT, CIRRUS™ HD-OCT 5000, Carl Zeiss Meditec Inc., Dublin, CA, USA) using 6 radial line scans through the fovea
* Macular leakage on fundus fluorescein angiography (HRA2, Heidelberg Engineering GmbH, Germany)
* The DME pattern can include submacular fluid, cystoid change, and diffuse macular thickening
* All have proliferative diabetic retinopathy treated by panretinal photocoagulation receiving prior vitrectomy without silicone oil or gas inside the vitreous cavity
* Prior intraocular surgery performed as least 3 months ago
Exclusion Criteria:
* Pregnant or nursing women
* The patients with the history of thromboembolic events or major surgery within the previous 3 months
* Presence of anterior chamber intraocular lens or subluxated/dislocated posterior chamber intraocular lens
* Presence of uncontrolled hypertension
* Known coagulation abnormalities or current use of anticoagulative medication other than aspirin
* Prior macular photocoagulation or photodynamic therapy
* Presence of active infectious disease or intraocular inflammation
* Intraocular pressure more than 20 mmHg or glaucoma history
* Presence of iris neovascularization/vitreous hemorrhage.
* The DME pattern with accompanying macular traction by epiretinal membrane or posterior hyaloid
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04089605
Study Brief:
Protocol Section:
NCT04089605