Effects of Antiplatelet and Antioxidant Agents on Drusen Progression: A Pilot, Prospective Cohort Study

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Antiplatelet and Antioxidant Agents on Drusen Progression: A Pilot, Prospective Cohort Study

Conditions
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Dry Age-related Macular Degeneration

Intervention / Treatment
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* Drug: Aspirin 81Mg Ec Tab
* Drug: Clopidogrel
* Drug: N-acetylcysteine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Aspirin 81 mg/d or Clopidogrel 75 mg/d Aspirin 81 mg/d or Clopidogrel 75 mg/d with N-acetylcysteine 600 mg/d No medication
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Antiplatelet drug<br>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. | Drug: Aspirin 81Mg Ec Tab<br>* Patients take aspirin 81 mg per day.<br>Drug: Clopidogrel<br>* Patients take clopidogrel 75 mg per day.<br>|
| Experimental: Antiplatelet drug with antioxidant<br>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. | Drug: Aspirin 81Mg Ec Tab<br>* Patients take aspirin 81 mg per day.<br>Drug: Clopidogrel<br>* Patients take clopidogrel 75 mg per day.<br>Drug: N-acetylcysteine<br>* Patients are given N-acetylcysteine 600 mg per day.<br>* Other names: NAC-long;|
| No Intervention: No medication<br>Patient with no medication used. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drusen volume analysis | To assess AMD progression in patient with large drusen, drusen volume was measured and analyzed in each patient group by OCT scan | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best-corrected visual acuity change | To evaluate Best-corrected visual acuity in each patient group by ETDRS chart | 1 year | 
| Rate of disease progression | To evaluate disease progression to geographic atrophy or neovascular AMD by OCT scan and fundus photo | 1 year | 
| Side effects of medications intake | To evaluate the safety of the medication used by questionnaire | 1 year |