NCT03135327 · RECRUITING

Clinical Applications of Advanced Ophthalmic Imaging

This study is testing whether advanced eye-imaging tools — including OCT scans and retinal imaging — can detect changes in the eyes of people with conditions like dementia, multiple sclerosis, and diabetes. A second phase gives participants a medical food supplement called Ocufolin for six months and tracks whether it changes what those imaging tools detect. This is a Phase NA designation, meaning it includes both observational and early interventional work, not a standard drug trial.

Eligibility criteria

Observational Phase 1 Group
Inclusion Criteria:
1. Self-reported normal healthy subjects;
2. Clinical diagnosis of Alzheimer's Disease, mild cognitive impairment, multiple sclerosis, dry eye, myopia, diabetics and stroke;
3. Who can keep the eye open for imaging.
Exclusion Criteria:
1. who can not read and sign the ICF;
2. who can not receiving ophthalmic imaging;
3. who cannot tolerate bright light during imaging.
Interventional Phase 2 Group:
Inclusion criteria
The participant will be eligible for entry in the study if s/he:
1. Is at least 18 years old and has full legal capacity to volunteer;
2. Has read and signed the IRB Informed Consent Document;
3. Is willing and able to follow participant instructions;
4. Has clear corneas and crystalline lens;
5. Initial visual acuities were 20/80 or better;
6. MTHFR C677TT homozygous, or MTHFR C677T/A1298C compound heterozygous with mild to moderate micro-aneurismal vascular retinopathy disease;
7. Hemoglobin A1c is 10 or less;
8. Normotensive with or without medications;
9. Without retinal capillary dropout or macular edema;
10. Blood homocysteine > 9.
Exclusion criteria
The subjects will be ineligible for entry into the study if s/he:
1. Has an active ocular disease;
2. Has had surgery or an eye injury within 6 months.

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2025-08-12

View full record on ClinicalTrials.gov

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