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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06165068
Enrollment
174
Registered
2023-12-11
Start date
2023-12-31
Completion date
2026-09-30
Last updated
2023-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Age-related Macular Degeneration

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.

Interventions

Patients take aspirin 81 mg per day.

DRUGClopidogrel

Patients take clopidogrel 75 mg per day.

DRUGN-acetylcysteine

Patients are given N-acetylcysteine 600 mg per day.

Sponsors

Navamindradhiraj University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

1. Aspirin 81 mg/d or Clopidogrel 75 mg/d 2. Aspirin 81 mg/d or Clopidogrel 75 mg/d with N-acetylcysteine 600 mg/d 3. No medication

Eligibility

Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Drusen volume analysis1 yearTo assess AMD progression in patient with large drusen, drusen volume was measured and analyzed in each patient group by OCT scan

Secondary

MeasureTime frameDescription
Best-corrected visual acuity change1 yearTo evaluate Best-corrected visual acuity in each patient group by ETDRS chart
Rate of disease progression1 yearTo evaluate disease progression to geographic atrophy or neovascular AMD by OCT scan and fundus photo
Side effects of medications intake1 yearTo evaluate the safety of the medication used by questionnaire

Countries

Thailand

Contacts

Primary ContactYolradee Winuntamalakul
yolradee.win@nmu.ac.th+66851283362

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026