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 @ 3:54 AM
Ignite Modification Date:
2025-12-25 @ 3:54 AM
NCT ID:
NCT05122702
Eligibility Criteria:
Inclusion Criteria:
* Both gender;
* Age from 18 to 80 years;
* Known diagnosed with ME;
* Agree to under optical examination and willing to complete questionnaires and take medications as scheduled; and
* Agree to participate in the study and provide written informed consent. (for those illiterate subjects, their family member can sign the consent form upon subject's agreement)
Exclusion Criteria:
* Known ocular media opacities, such as cataract, vitreous hemorrhage, asteroid hyalosis, that affect the determination of retinal thickness from OCT imaging;
* Known clinically significant macular edema (CSME). The definition of CSME: if one or more of the following criteria are met 1) retinal thickening at or within 500 μm of the center of the macula; 2) hard exudates at or within 500 μm of the center of the macula, if associated with adjacent retinal thickening; 3) a zone or zones of retinal thickening one disc area in size, at least part of which is within one disc diameter of the center of the macula;
* On concomitant oral or injectable corticosteroids, topical non-steroidal anti-inflammatory drugs (NSAID) eye drops, leukotriene inhibitors, anti-VEGF, immunosuppressants for the treatment of ME within past 6 months or other Chinese herbal medicine for the treatment of ME within past month;
* Impaired hematological profile and liver / renal function exceeds the upper limit of the reference value by 2 times;
* Documented pregnant or lactating; or
* Subjects participating in other clinical studies at the same time.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05122702
Study Brief:
Protocol Section:
NCT05122702