Effects of Antiplatelet and Antioxidant Agents on Drusen Progression: A Pilot, Prospective Cohort Study
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Navamindradhiraj University
- Enrollment
- 174
- Locations
- 1
- Primary Endpoint
- Drusen volume analysis
Study Overview
Brief Summary
The aim of this clinical trial is to evaluate the effect of low doses of antiplatelet medications (aspirin 81 mg/day or clopidogrel 75 mg/day) with or without a combination of antioxidants (N-acetylcysteine 600 mg/day) in a dry AMD patient with large drusen.
Participants will divided in to three groups.
- Participants who were already taking low dose antiplatelet medications.
- Participants who take the antiplatelet drug mentioned above in addition to the antioxidant prescribed by the investigator
- Participants does not use any medications.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Dry AMD with at least 1 large drusen. According to the AREDS study, large drusen have a size of more than 125 micron.
- •Patients can evaluate SD-OCT (Spectral domain optical coherence tomography), OCT angiography, and best-corrected visual acuity.
- •Age range: 50-85 years
- •Patients who have previously used antiplatelet drugs.
Exclusion Criteria
- •Patient with advanced AMD, such as geographic atrophy, neovascular complications (choroidal neovascularization)
- •Patient with additional retinal diseases that affect visual acuity, e.g., retinal detachment, diabetic macular edema.
- •Patient with a history of intravitreal anti-VEGF injection or macular laser.
- •Patient using SSRIs, SNRIs, azole, NSAIDs, dual antiplatelet, anticoagulant medications.
Arms & Interventions
Antiplatelet drug
In this study, antiplatelet drugs are medications that patients take to treat their underlying condition, such as aspirin 81 mg/day or clopidogrel 75 mg/day.
Intervention: Aspirin 81Mg Ec Tab (Drug)
Antiplatelet drug
In this study, antiplatelet drugs are medications that patients take to treat their underlying condition, such as aspirin 81 mg/day or clopidogrel 75 mg/day.
Intervention: Clopidogrel (Drug)
Antiplatelet drug with antioxidant
Antiplatelet drugs are medications that patients take to treat their underlying condition, such as aspirin 81 mg/day or clopidogrel 75 mg/day combined with N-acetylcysteine 600 mg/day.
Intervention: Aspirin 81Mg Ec Tab (Drug)
Antiplatelet drug with antioxidant
Antiplatelet drugs are medications that patients take to treat their underlying condition, such as aspirin 81 mg/day or clopidogrel 75 mg/day combined with N-acetylcysteine 600 mg/day.
Intervention: Clopidogrel (Drug)
Antiplatelet drug with antioxidant
Antiplatelet drugs are medications that patients take to treat their underlying condition, such as aspirin 81 mg/day or clopidogrel 75 mg/day combined with N-acetylcysteine 600 mg/day.
Intervention: N-acetylcysteine (Drug)
Outcomes
Primary Outcomes
Drusen volume analysis
Time Frame: 1 year
To assess AMD progression in patient with large drusen, drusen volume was measured and analyzed in each patient group by OCT scan
Secondary Outcomes
- Side effects of medications intake(1 year)
- Best-corrected visual acuity change(1 year)
- Rate of disease progression(1 year)
Investigators
Yolradee Winuntamalakul
Principal Investigator
Navamindradhiraj University