Ocufolin for Eye Conditions

Overseen By Jianhua Wang, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Active ocular disease, Recent eye surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

5000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how advanced eye imaging tools can enhance understanding of various eye conditions and their changes when taking Ocufolin, a medical food, for six months. The first phase observes eye conditions, while the second phase tests Ocufolin's effects. Suitable candidates for the observational phase include individuals with conditions like Alzheimer's or diabetes. For the interventional phase, participants must have certain eye health criteria and mild to moderate retinopathy, a condition affecting blood vessels in the eye. Participants should also possess specific genetic markers related to MTHFR and a blood test result showing homocysteine levels over 9. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research on eye health and potential treatments.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants can be normotensive (normal blood pressure) with or without medications, suggesting some medications might be allowed.

Is there any evidence suggesting that Ocufolin is likely to be safe for humans?

Research has shown that Ocufolin, a type of medical food, is generally safe for most people. In one study, participants took Ocufolin for six months without major safety issues. Another study found that a key ingredient in Ocufolin was well-tolerated over three months, with no serious side effects reported.

Manufactured in the USA under strict quality standards, Ocufolin's production ensures its safety. It is important to use Ocufolin under a doctor's guidance.

For those considering a clinical trial with Ocufolin, previous research suggests the treatment is safe. However, always consult a healthcare provider to ensure it is appropriate for you. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Ocufolin is unique because it is a medical food specifically designed to support eye health, which sets it apart from traditional treatments like eye drops or pharmaceuticals that primarily focus on symptom management. Unlike other treatments that often target symptoms of eye conditions, Ocufolin provides nutritional support that may help improve underlying eye health. Researchers are excited about Ocufolin because it offers a non-invasive approach, potentially reducing the need for more aggressive treatments while addressing the root causes of eye conditions through nutrition.

What evidence suggests that Ocufolin might be an effective treatment for eye conditions?

Research has shown that Ocufolin, which participants in this trial may receive, can aid eye conditions by improving retinal health. Studies have found that it can reduce homocysteine levels in the blood by 23%. High homocysteine levels are linked to eye problems. Ocufolin also enhances blood flow in the eye's tiny blood vessels, crucial for good vision. Additionally, it benefits individuals with eye issues related to diabetes and high blood pressure by supporting these blood vessels' health. These findings suggest Ocufolin could be a promising option for supporting eye health in various conditions. Participants in the interventional phase of this trial will receive Ocufolin for six months, while those in the observational phase will be studied and followed up for one to two years. ^{2 6 7 8 9}

Who Is on the Research Team?

Jianhua Wang, MD, PHD

Principal Investigator

Bascom Palmer Eye Institute, University of Miami, Miami, FL

Are You a Good Fit for This Trial?

This trial is for adults with clear vision of at least 20/80 who have conditions like dementia, MS, dry eye, diabetic retinopathy, or near-sightedness. They must be able to undergo advanced eye imaging and have had no recent eye surgery or injury. People with active ocular diseases or intolerance to bright light during imaging cannot participate.

Inclusion Criteria

Has read and signed the IRB Informed Consent Document

Your blood homocysteine level is higher than 9.

I can keep my eye open for pictures.

Exclusion Criteria

I have an ongoing eye condition.

Who can not receiving ophthalmic imaging

You are not able to read and sign the informed consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observational

The eye is studied in various conditions using advanced ophthalmic imaging devices

1-2 years

Interventional

Participants receive Ocufolin medical food and changes in the eyes are studied

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Ocufolin

Trial Overview The study first observes the eyes using technologies like OCT and RFI. Then it tests if taking Ocufolin—a medical food—over six months can change the eyes' condition in people with various ophthalmic disorders compared to normal healthy subjects.

How Is the Trial Designed?

Group I: Interventional Phase - Ocufolin Group Experimental Treatment 1 Intervention

Participants in this group will receive the Ocufolin medical food for 6 months.

Group II: Observational Phase Group Active Control 1 Intervention

Participants in this group will be studied and followed up for 1-2 years.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Published Research Related to This Trial

Obtusofolin, the main active ingredient in Catsia tora L., significantly inhibits the activity of key cytochrome P450 enzymes (CYP3A4, CYP2C9, and CYP2E1) in a dose-dependent manner, which could affect the metabolism of other drugs.

The inhibition of CYP3A4 by obtusofolin follows a non-competitive model, while CYP2C9 and CYP2E1 are inhibited competitively, suggesting potential drug-drug interactions that warrant further investigation in vivo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro inhibitory effect of obtusofolin on the activity of CYP3A4, 2C9, and 2E1. Liu, N., Chen, P., Du, X., et al.[2021]

Patients with Balkan endemic nephropathy (BEN) had significantly higher serum levels of ochratoxin A (OTA), suggesting a strong association between OTA exposure and the disease.

In the offspring of BEN patients, higher levels of OTA were linked to increased excretion of β2-microglobulin, indicating potential kidney impairment related to OTA exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ochratoxin A and β2-microglobulin in BEN patients and controls. Yordanova, P., Wilfried, K., Tsolova, S., et al.[2021]

Ophiopogonin D (OPD) is effectively taken up by rat hepatocytes and human OATP1B1 cells, with specific transport mechanisms involving organic anion transporting polypeptides (OATPs), particularly oatp1b2 in rats and OATP1B1 in humans.

The uptake of OPD is significantly inhibited by certain compounds like rosuvastatin and glycyrrhizic acid, indicating that these transporters play a crucial role in its hepatic absorption, which could impact its therapeutic efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hepatic Uptake Mechanism of Ophiopogonin D Mediated by Organic Anion Transporting Polypeptides. Zhang, W., Xiong, X., Chen, L., et al.[2018]

Ophiopogonin D (OP-D) significantly reduced blood lipid levels and alleviated mitochondrial injury in diabetic mice, suggesting its potential as a cardioprotective agent against diabetic myocardial injury.

In vitro studies showed that OP-D improved cell survival and mitochondrial function in cardiomyocytes exposed to palmitic acid, indicating that its cardioprotective effects may be linked to the regulation of mitochondrial dynamics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ophiopogonin D alleviates diabetic myocardial injuries by regulating mitochondrial dynamics. Li, W., Ji, L., Tian, J., et al.[2021]

Ophiopogonin D significantly reduces the viability and colony formation of human breast cancer MCF-7 cells in a dose-dependent manner, indicating its potential as an effective treatment.

The mechanism of action involves inducing cell cycle arrest at the G(2)/M phase and promoting apoptosis through the activation of caspase-8 and caspase-9, highlighting its role in inhibiting cancer cell growth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ophiopogonin D inhibits cell proliferation, causes cell cycle arrest at G2/M, and induces apoptosis in human breast carcinoma MCF-7 cells. Zang, QQ., Zhang, L., Gao, N., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12020837/

The effect of a specific vitamin supplement containing L ... When Ocufolin forte was added to the standard therapy, RVP and Hcy were reduced to a significantly greater extent than without Ocufolin forte.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12461035/

Blood Based Vascular Marker Responses to Ocufolin® in ... Result: Treatment with Ocufolin® resulted in a 23% decrease in serum homocysteine (P = . 005), an 18% decrease in hsCRP, a 13% decrease in ...

3. ocufolin.ch ocufolin.ch/fachportal/publikationen-ocufolin

Publikationen Ocufolin® We report a series of diabetic and hypertensive retinopathy cases with MTHFR polymorphisms and the improvement of retinal microvasculature (mainly MAs)

4. ocufolin.ch ocufolin.ch/images/KOLAerztebroschueren/Mini_Review_Ocufolin.pdf

The New Way in DR and AMD Supplementation Folate deficiency has been identified as an impor- tant pathogenic factor in eye diseases such as AMD. Insufficient folate levels lead to increased homocys ...

5. tandfonline.com tandfonline.com/doi/full/10.2147/OPTH.S358753

Improved Retinal Microcirculation in Mild Diabetic ... Ocufolin may be effective in improving both visual acuity and retinal microcirculation in patients with DR + PM.

6. ocufolin.com ocufolin.com/

Ocufolin Medical Food Ocufolin is a medical food for use only under medical supervision for the dietary management of retinal ischemia and associated conditions.

7. ocufolin.com ocufolin.com/pages/ingredients

Ingredients Ocufolin® is manufactured in the USA as a Medical Food under cGMP standards. Ocufolin® is patented for methods of treating optic disorders under US Patent ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7190578/

A pilot study to assess the effect of a three-month vitamin ... In conclusion, the present data show that a three-month oral supplementation of L-methylfolate and additional dietary supplements is safe and ...

9. drc.bmj.com drc.bmj.com/content/9/1/e002327

Effects of Ocufolin on retinal microvasculature in patients ... In this study, patients entered with mild or no visual impairment. After receiving Ocufolin for 6 months, eight eyes sustained improved BCVA, ...