Actively Recruiting
Effects of Antiplatelet and Antioxidant Agents on Drusen Progression: A Pilot, Prospective Cohort Study
Led by Navamindradhiraj University · Updated on 2023-12-15
174
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of low doses of antiplatelet medications, such as aspirin 81 mg/day or clopidogrel 75 mg/day, with or without the addition of antioxidants (N-acetylcysteine 600 mg/day) in patients with dry age-related macular degeneration (AMD) who have large drusen. The study will include participants aged 50 to 85 years and is sponsored by Navamindradhiraj University. It is a Phase 3, non-randomized, interventional clinical trial focused on understanding how these treatments may influence drusen progression. Participants will be divided into three groups: those already taking low-dose antiplatelet medications, those who will take antiplatelet drugs combined with antioxidants as prescribed by the investigator, and those who do not use any medication. The antiplatelet medications studied include aspirin and clopidogrel, both taken daily, and the antioxidant used is N-acetylcysteine, also taken daily. The trial will monitor participants over one year. During the study, participants will undergo evaluations including drusen volume analysis, best-corrected visual acuity testing, and assessments of disease progression and side effects from medication intake. These measurements will be taken over a 1-year period to assess the impact of the treatments. The trial does not involve masking or blinding, and participants will be monitored for safety and treatment effects throughout the study duration.
CONDITIONS
Brief Title
Effects of Antiplatelet and Antioxidant Agents on Drusen Progression: A Pilot, Prospective Cohort Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Dry AMD with at least 1 large drusen (size over 125 microns).
- Ability to undergo SD-OCT, OCT angiography, and best-corrected visual acuity testing.
- Age between 50 and 85 years.
- Previous use of antiplatelet drugs.
You will not qualify if you...
- Advanced AMD, including geographic atrophy or neovascular complications.
- Presence of other retinal diseases affecting vision, such as retinal detachment or diabetic macular edema.
- History of intravitreal anti-VEGF injection or macular laser treatment.
- Current use of SSRIs, SNRIs, azole medications, NSAIDs, dual antiplatelet therapy, or anticoagulants.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 year
Participants take antiplatelet drugs such as aspirin 81 mg/day or clopidogrel 75 mg/day, with or without N-acetylcysteine 600 mg/day, or receive no medication as part of the study.
Regular visits during the 1 year treatment period
Trial Site Locations
Total: 1 location
1
Department of ophthalmology, Faculty of medicine, Vajira hospital, Navamindradhiraj University
Bangkok, Dusit, Thailand, 10300
Actively Recruiting
Research Team
Y
Yolradee Winuntamalakul
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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