ISRCTN82949875进行中（未招募）2 期
Oral glycoside supplement (triterpenoid saponins) for early and intermediate stage age-related macular degeneration: an exploratory randomised placebo-controlled trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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