Saponins for macular disease
- Conditions
- Men and women with early or intermediate stage age-related macular degeneration (AMD) in the trial eye and any stage of AMD in the non-trial eyeEye Diseases
- Registration Number
- ISRCTN82949875
- Lead Sponsor
- Cardiff University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 60
Current participant inclusion criteria as of 25/07/2024:
1. Aged 60 to 85 years old (inclusive)
2. Able to provide informed consent and comply with the trial visit schedule
3. AMD in both eyes (of any stage)
4. Early or intermediate stage AMD (Beckman classification) in at least one eye
Previous participant inclusion criteria:
1. Aged 55 to 85 years old (inclusive)
2. Able to provide informed consent and comply with the trial visit schedule
3. AMD in both eyes (of any stage)
4. Early or intermediate stage AMD (Beckman classification) in at least one eye
Current participant exclusion criteria as of 25/07/2024:
1. Ocular pathology in the study eye (or in either eye for genetic conditions or glaucoma), other than age-related macular degeneration, which may affect visual function
2. Intraocular pressure of 24 mmHg or greater
3. Grade <2 van Herick or history of allergic reaction to dilating eye drops
4. Unable to classify AMD grade
5. Lens opacity greater than grade 2 on any Lens Opacities Classification System III (LOCS III) criterion, or other media opacity/nystagmus that might interfere with quality retinal imaging
6. Diabetes
7. Vitamin A deficiency
8. Other significant systemic disease or medication known to affect visual or retinal function
9. Systemic illness that would compromise participation in a 1-year trial
10. Actively under treatment for cancer
11. Diagnosed with cancer with ocular involvement
12. Insufficient English language comprehension
13. A possible cognitive impairment as determined using an abridged Mini-Cog. This is defined as a score of less than 3.
14. Known or suspected seafood allergy
15. Photosensitive epilepsy
16. Currently treated with warfarin or other vitamin K antagonist
17. Participation in any other interventional trial within 30 days prior to entering this trial
18. Men who are planning a pregnancy with their partner or have partners who are women of childbearing potential
19. Taking supplements containing saponins (e.g. ginseng)
20. Unable to consume the IMP or placebo for a period of longer than 24 hours during the treatment window (for example a prolonged fast or repeated 24-hour fast)
21. Participants undergoing planned, forthcoming major surgical interventions
Previous participant exclusion criteria:
1. Ocular pathology in the study eye (or in either eye for genetic conditions or glaucoma), other than age-related macular degeneration, which may affect visual function
2. Intraocular pressure of 24 mmHg or greater
3. Grade <2 van Herick or history of allergic reaction to dilating eye drops
4. Unable to classify AMD grade
5. Lens opacity greater than grade 2 on any Lens Opacities Classification System III (LOCS III) criterion, or other media opacity/nystagmus that might interfere with quality retinal imaging
6. Diabetes
7. Vitamin A deficiency
8. Other significant systemic disease or medication known to affect visual or retinal function
9. Systemic illness that would compromise participation in a 1-year trial
10. Actively under treatment for cancer
11. Diagnosed with cancer with ocular involvement
12. Insufficient English language comprehension
13. A possible cognitive impairment as determined using an abridged Mini-Cog. This is defined as a score of less than 3.
14. Known or suspected seafood allergy
15. Photosensitive epilepsy
16. Currently treated with warfarin or other vitamin K antagonist
17. Participation in any other interventional trial within 30 days prior to entering this trial
18. Women who are pregnant, lactating or planning a pregnancy, or men who have a partner who is planning a pregnancy
19. Taking supplements containing saponins (e.g. ginseng)
20. Unable to consume the IMP or placebo for a period of longer than 24 hours during the treatment window (for example a prolonged fast or repeated 24-hour fast)
21. Participants undergoing planned, forthcoming major surgical interventions
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method