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 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT03866005
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed diabetes mellitus and treatment-naïve CI-DME requiring anti-VEGF therapy per retinal specialist's customary treatment regimen will be recruited to participate in the study. CI-DME will be defined as a central subfield thickness (CST) \> 300 microns on spectral domain optical coherence tomography (SD-OCT) or CST \> 250 microns with definite intra-retinal cystic fluid accumulation. Additional inclusion criteria are age \> 18 years, and ability to give informed consent.
Exclusion Criteria:
* Age \< 18 years, inability to give informed consent, evidence of proliferative diabetic retinopathy, evidence of other serious ocular disease (age-related macular degeneration, glaucoma, significant media opacity), history of previous intraocular surgery, including macular or panretinal photocoagulation (except uncomplicated cataract or keratorefractive surgery more than 6 months prior to enrollment), pregnant and nursing women, known sensitivity to any of the supplement ingredients.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03866005
Study Brief:
Protocol Section:
NCT03866005