Effects of Antiplatelet and Antioxidant Agents on Drusen Progression: A Pilot, Prospective Cohort Study
- Conditions
- Dry Age-related Macular Degeneration
- Interventions
- Registration Number
- NCT06165068
- Lead Sponsor
- Navamindradhiraj University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 174
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Antiplatelet drug with antioxidant Aspirin 81Mg Ec Tab 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. Antiplatelet drug Aspirin 81Mg Ec Tab 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. Antiplatelet drug Clopidogrel 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. Antiplatelet drug with antioxidant N-acetylcysteine 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. Antiplatelet drug with antioxidant Clopidogrel 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.
- Primary Outcome Measures
Name Time Method Drusen volume analysis 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 Outcome Measures
Name Time Method Side effects of medications intake 1 year To evaluate the safety of the medication used by questionnaire
Best-corrected visual acuity change 1 year To evaluate Best-corrected visual acuity in each patient group by ETDRS chart
Rate of disease progression 1 year To evaluate disease progression to geographic atrophy or neovascular AMD by OCT scan and fundus photo
Trial Locations
- Locations (1)
Department of ophthalmology, Faculty of medicine, Vajira hospital, Navamindradhiraj University
🇹ðŸ‡Bangkok, Dusit, Thailand