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 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT02406157
Eligibility Criteria:
Inclusion Criteria:
* Aged \>18 years
* Patients with diabetes mellitus type 2
* Diagnosed as diabetic retinopathy with Clinical Significant Macular Edema
* Central retinal thickness(CRT) of more than 250μm as measured by optical coherence tomography (OCT)
* ETDRS visual acuity \>19 letters (Snellen equivalent of 20/400 or better)
* No macular laser coagulation or surgery or medicine therapy of macular edema within the last 6 months
* Blood glucose was controlled steadily(HbA1c≤10%)
Exclusion Criteria:
* Taking part in other clinical trial within 3 months
* Planning panretinal photocoagulation(PRP) within 3 months
* Performed cataract surgery in the last 3 months
* Accompanied with other retinal vascular disease that can lead to macular edema, for example branch retinal vein occlusion(BRVO),central retinal vein occlusion(CRVO)
* Accompanied with severe opacity of refractive media that maybe impact therapy and observation
* Accompanied with nystagmus
* Accompanied with some history that maybe interfere with result or increase the risk of patients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
80 Years
Study:
NCT02406157
Study Brief:
Protocol Section:
NCT02406157