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 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT07295704
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years.
* Both sexes.
* Patients with type 1 or 2 diabetes mellitus (DM), best-corrected visual acuity (BCVA) of 20/400 or better, and center-involved DME \[defined as a central macular thickness (CMT) of \>250 but \<700µm measured by spectral-domain optical coherence tomography\].
* Patients with any level of non-proliferative diabetic retinopathy or proliferative diabetic retinopathy with adequate panretinal photocoagulation (PRP) and no signs of disease activity determined by fluorescein angiography (FA).
Exclusion Criteria:
* Monocular eyes.
* Chronic renal failure or renal transplant because of diabetic nephropathy.
* Glycated hemoglobin (HbA1c) of more than 10%.
* Vitreomacular traction syndrome.
* Epiretinal membrane.
* PRP within 4months before the treatment.
* Intraocular surgery within 6months, including cataract or vitreoretinal operation.
* Rubeosis iridis.
* Severe glaucoma.
* High-risk proliferative diabetic retinopathy.
* Poor dilation.
* Increased foveal avascular zone.
* Any condition that could interfere with optical coherence tomography (OCT) measurement or visual acuity.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07295704
Study Brief:
Protocol Section:
NCT07295704