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

Dry Age-related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06165068
• Other study ID #: 193/65 FB
• Status: Recruiting
• Phase: Phase 3
• Start date: December 2023
• Est. completion date: September 2026

Study information

• Verified date: December 2023
• Source: Navamindradhiraj University
• Contact: Yolradee Winuntamalakul
• Phone: +66851283362
• Email: yolradee.win[@]nmu.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 174
• Est. completion date: September 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dry Age-related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• Aspirin 81Mg Ec Tab
Patients take aspirin 81 mg per day.
• Clopidogrel
Patients take clopidogrel 75 mg per day.
• N-acetylcysteine
Patients are given N-acetylcysteine 600 mg per day.

Locations

Country	Name	City	State
Thailand	Department of ophthalmology, Faculty of medicine, Vajira hospital, Navamindradhiraj University	Bangkok	Dusit

Sponsors (1)

Lead Sponsor	Collaborator
Navamindradhiraj University

Country where clinical trial is conducted

Thailand, 

Outcome

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