None listed
Conditions
Interventions
Dietary Supplement : 1. Treatment group: NEP8
1) Name of Active Ingredient: Broussonetia kazinoki Extract
2) Dosage Form and Appearance: Capsule
3) Strength: 520 mg
4) Storage Conditions: Store at
Sponsors
The Catholic University of Korea, St. Vincent's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male subjects aged 40 years or older up to 84 years, and postmenopausal women who have had amenorrhea for at least 2 years. 2. Subjects who have exudative (wet) age-related macular degeneration (AMD) in at least one eye, or subjects with early to intermediate-stage non-exudative (dry) age-related macular degeneration (AMD). 3. Subjects who have voluntarily provided written informed consent and are able to comply with all study-related visits, examinations, and procedures during the study period
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of hypersensitivity to the investigational product or any of its components. 2. Subjects with extensive geographic atrophy due to age-related macular degeneration or with best-corrected visual acuity (BCVA) = 0.5 due to macular degeneration (if both eyes are eligible, the eye with worse visual acuity will be selected). 3. Subjects with serious ophthalmic diseases other than macular degeneration that may affect visual function during the study period (e.g., severe glaucoma, branch retinal vein occlusion), or those who have undergone or are undergoing retinal surgery or retinal laser treatment. 4. Subjects with severe cataract, corneal opacity, or signs of exudative changes including intraretinal/subretinal fluid, pigment epithelial detachment, or hemorrhage. 5. Subjects with high myopia greater than 6 diopters. 6. Subjects with severe obesity (BMI = 33 kg/m²). 7. Subjects diagnosed with hyperlipidemia who are receiving medication or dietary therapy (however, subjects who have been on a stable regimen for at least 3 months prior to screening and with no planned change in dosage during the study period may be included at the investigator’s discretion). 8. Subjects with uncontrolled hyperlipidemia (Total cholesterol > 240 mg/dL at screening). 9. Subjects diagnosed with dementia, brain tumor, or hydrocephalus, or those who have received or are receiving hormone replacement therapy within 4 weeks prior to screening. 10. Subjects with a history of stroke or myocardial infarction within 6 months prior to screening, or with clinically significant arrhythmia requiring treatment. 11. Subjects with a history of malignancy within 5 years prior to screening (except those who have been disease-free for at least 2 years after curative treatment, or those with basal cell carcinoma, squamous cell carcinoma of the skin, thyroid cancer, or carcinoma in situ of other sites). 12. Subjects who are deemed unsuitable for participation due to severe dementia, depression, pulmonary disease, or other serious medical conditions. 13. Subjects with uncontrolled hypertension (SBP = 160 mmHg or DBP = 95 mmHg), or with poorly controlled diabetes despite medication (HbA1c = 9.0%). 14. Subjects who have undergone gastrointestinal surgery (e.g., gastrectomy) that may affect absorption of the investigational product and who are taking medication related to such gastrointestinal diseases. 15. Subjects with severe renal impairment (serum creatinine > 2.0 mg/dL) or hepatic impairment (ALT, AST, or ALP > 2.5 × upper limit of normal). 16. Subjects with a history and treatment of malignancy within 5 years prior to screening. 17. Subjects with a history of drug or alcohol abuse. 18. Pregnant or breastfeeding women, or men who do not agree to use appropriate contraception. 19. Subjects who have taken other functional foods for human application or investigational drugs within 3 months prior to screening. 20. Subjects who are considered by the investigator to be unsuitable for participation or unable to comply with the study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in macular pigment optical density (MPOD) | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of change in macular pigment optical density (MPOD);Change and rate of change in central macular thickness;Change and rate of change in retinal pigment epithelium (RPE) thickness;Change and rate of change in vascular density measured by optical coherence tomography angiography (OCTA);Change and rate of change in best-corrected visual acuity (BCVA);Change and rate of change in total score of the subjective eye fatigue questionnaire | — |
Countries
Korea, Republic of
Contacts
Public ContactDonghyun Jee
The Catholic University of Korea, St. Vincent's Hospital
Outcome results
None listed