Effects of Antiplatelet and Antioxidant Agents on Drusen Progression: A Pilot, Prospective Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aspirin 81Mg Ec Tab, Clopidogrel, N-acetylcysteine.
- Who it may be relevant to
- Registry conditions: Dry Age-related Macular Degeneration. Basic parameters: 50 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Aspirin 81Mg Ec Tab
Patients take aspirin 81 mg per day. - Drug Clopidogrel
Patients take clopidogrel 75 mg per day. - Drug N-acetylcysteine
Patients are given N-acetylcysteine 600 mg per day.
Primary outcome measures
- Drusen volume analysis [Time frame: 1 year]
Secondary outcome measures (3)
- Best-corrected visual acuity change [Time frame: 1 year]
- Rate of disease progression [Time frame: 1 year]
- Side effects of medications intake [Time frame: 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Thailand · 1 center
- Department of ophthalmology, Faculty of medicine, Vajira hospital, Navamindradhiraj Univer — Bangkok
Identifiers
NCT: NCT06165068 · 193/65 FB