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

Navamindradhiraj University

Status and phase: Enrolling; Phase 3

Conditions: Dry Age-related Macular Degeneration

Treatments: Drug: N-acetylcysteine; Drug: Clopidogrel; Drug: Aspirin 81Mg Ec Tab

Study type: Interventional

Funder types: Other

Identifiers

NCT06165068

193/65 FB

Details and patient eligibility

About

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.

Enrollment: 174 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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174 participants in 3 patient groups

Antiplatelet drug

Active Comparator group

Description:

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.

Treatment:

Drug: Aspirin 81Mg Ec Tab

Drug: Clopidogrel

Antiplatelet drug with antioxidant

Experimental group

Description:

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.

Treatment:

Drug: Aspirin 81Mg Ec Tab

Drug: N-acetylcysteine

Drug: Clopidogrel

No medication

No Intervention group

Description:

Patient with no medication used.