None listed
Conditions
Interventions
Dietary Supplement : 1) Test group(KGC15D)
Active Ingredient: KGC15D
Appearance and Dosage Form: Tablet
Content: 500 mg/tablet
Storage Condition: Sealed, at room temperature
Dosage and Administration:
Sponsors
Korea Ginseng Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults aged 40 to 85 years (inclusive) at the time of screening, with a macular pigment optical density (MPOD) of = 0.5 density units (D.U.). 2) Subjects diagnosed with dry age-related macular degeneration (AMD) corresponding to age-related eye disease (AREDS) Early AMD (Category 2–3). - Subjects are eligible if at least one eye meets the criteria. - In cases where both eyes meet the criteria, the more severely affected eye will be designated as the study eye. 3) Subjects who voluntarily provide written informed consent, and who are able to understand, comply with, and complete the study procedures and requirements
Exclusion criteria
Exclusion criteria: 1) Subjects with any of the following medical conditions: - Hyperlipidemia - Acute infectious diseases, including but not limited to sepsis, meningitis, or pyelonephritis - History of malignancy within 5 years prior to the screening visit, or currently receiving treatment for malignancy - Chronic renal failure or subjects currently undergoing dialysis - Chronic obstructive pulmonary disease (COPD) - Severe cardiac disease, including heart failure - Subjects currently receiving treatment for retinal diseases other than age-related macular degeneration (AMD) - History of retinal diseases other than with a potential risk of recurrence (Subjects may be eligible if, in the opinion of the Principal Investigator, the condition has remained stable for a prolonged period without recurrence or is not expected to have a clinically significant impact on study outcomes) - Subjects with a history of macular diseases other than the target condition, or those with macular lesions associated with a high risk of progression to wet AMD, including: Pigment epithelial detachment (PED) = 0.5 mm, Retinal hemorrhage, Geographic atrophy, Intraretinal or subretinal fluid, Other signs of exudative changes - Subjects with a central macular thickness exceeding 300 µm on optical coherence tomography (OCT). - Subjects with diabetic complications of moderate non-proliferative diabetic retinopathy (NPDR) or worse. - Subjects with a history of infectious ocular disease within 3 months prior to the screening visit. - Subjects with high myopia of = 6 diopters at the screening visit. - Subjects with intraocular pressure (IOP) > 21 mmHg at the screening visit. - Subjects with cataract or corneal opacity severe enough to prevent adequate retinal imaging of the study eye. - Subjects currently receiving treatment for glaucoma. - Subjects with other abnormalities of the optic nerve. - Subjects with uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg). - Subjects with uncontrolled diabetes mellitus, defined as: - Fasting blood glucose > 180 mg/dL, or - Initiation of new antidiabetic medication within 3 months prior to the screening visit - Subjects with serum creatinine = 2.0 mg/dL. - Subjects with AST or ALT levels = 3 times the upper limit of normal (ULN). 2) Subjects with drug or substance abuse. 3) Subjects receiving long-term treatment with immunosuppressants or systemic corticosteroids. 4) Subjects who have received hormone replacement therapy within 2 months prior to the screening visit, or who are expected to require hormone replacement therapy during the study period. 5) Subjects currently using lipid-lowering medications or lipid-control diets. 6) Subjects who have used medications or health functional foods related to the maintenance of macular pigment optical density or improvement of macular function within 2 months prior to the screening visit, including but not limited to: Antithrombotic or blood circulation–enhancing agents, Anti-inflammatory or immunomodulatory agents, Metabolic regulators or hormonal agents, Lutein, zeaxanthin, astaxanthin, Omega-3 fatty acids, Antioxidants such as zinc and selenium , Bilberry extract, Prescription high-dose vitamins (Subjects may be eligible if they continue the same type and dosage of previously used vitamin supplements with
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Macular Pigment Optical Density | — |
Secondary
| Measure | Time frame |
|---|---|
| Optical coherence tomography;Retinal degeneration;Visual Analog Scale;Eye Strain Questionniare;Brain-derived neurotrophic factor | — |
Countries
Korea, Republic of
Contacts
Public ContactSOO KYOUNG LIM
Samsung Medical Center
Outcome results
None listed