Age-Related Macular Degeneration
Conditions
Keywords
dry age-related macular degeneration, krill oil
Brief summary
This randomized, double-blind, placebo-controlled study aims to evaluate the effect of krill oil supplementation in patients with dry age-related macular degeneration (AMD). Participants will receive 4 capsules of krill oil or placebo daily for a period of 3 months. Outcomes will be evaluated after 3-month treatment to assess differences between the two study groups.
Interventions
DIETARY_SUPPLEMENTKrill Oil
Qualified subjects start to take supplementation from Day 1 in the trial. Specifically, subjects from Intervention group take 4 capsules of krill oil per day.
DIETARY_SUPPLEMENTOlive Oil
Qualified subjects start to take placebo from Day 1 in the trial. Specifically, subjects from placebo group take 4 capsules of olive oil, which has the same color and smell as the krill oil.
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Adults diagnosed with dry AMD at an early or intermediate stage, classified according to the Beckman Classification and confirmed by fundus photography: (1) Early AMD: medium drusen (\>63 μm and ≤125 μm) without AMD-related pigmentary abnormalities; (2) Intermediate AMD: large drusen (\>125 μm), with or without AMD-related pigmentary abnormalities. * Willing to stop supplementation of omega-3 fatty acids, choline, or astaxanthin. * Willing to sign the informed consent, and willing to attend follow-up visits for at least 3 months.
Exclusion criteria
* Any eye with disease that would interfere with the fundus examinations. * Eye with choroidal neovascularization (CNV), geographic atrophy (GA), or high myopia. * Surgeries that may interfere with AMD evaluation. * Long-term use of any medications that are associated with retinal or neural toxicities. * History of supplementation with lutein, zeaxanthin, DHA, or EPA, unless a wash-out period of at least 8 weeks is completed prior to enrollment. * Intraocular pressure more than 26 mmHg. * Received cataract surgery in 3 months. * Other conditions: subjects with severe systemic diseases; any condition that causes high risk of drop-out, or low compliance, for instance cognition disorder; have been involved in other trial that interfere with the current visit plan; taking other angiogenesis Inhibitors drugs for treating cancer. * Other conditions not suitable for the current study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Macular Drusen Volume | From enrollment to the end of follow-up at 3 months. | Macular drusen volume will be quantified using spectral-domain optical coherence tomography (SD-OCT). Automated segmentation of Bruch's membrane and the retinal pigment epithelium (RPE), followed by manual verification, will be performed to calculate drusen volume at baseline and after 3 months of intervention at the same retinal location. Change in macular drusen volume will be defined as the percentage change from baseline, calculated as the difference between post-intervention and baseline drusen volume divided by the baseline drusen volume. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Maximum Macular Drusen Height | From enrollment to the end of follow-up at 3 months. | Maximum macular drusen height will be measured using SD-OCT at baseline and after 3 months of intervention. Change in maximum macular drusen height will be defined as the percentage change from baseline, calculated as the difference between post-intervention and baseline maximum drusen height divided by the baseline maximum drusen height. |
| Change in Best-Corrected Visual Acuity | From enrollment to the end of follow-up at 3 months. | Best-corrected visual acuity (BCVA) will be assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart and quantified as the total number of letters correctly identified by the participant. Change in BCVA will be defined as the absolute change in ETDRS letters from baseline, calculated as the difference between post-intervention and baseline measurements. |
| Change in Self-Reported Visual Function | From enrollment to the end of follow-up at 3 months. | Self-reported visual function will be assessed using the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25). Change in self-reported visual function will be defined as the absolute change in NEI VFQ-25 total score from baseline, calculated as the difference between post-intervention and baseline scores. |
Countries
China
Contacts
Primary ContactHuixun Jia, PhD
Backup ContactJiayu Xu
Outcome results
None listed