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RecruitingNCT06165068Updated Dec 15, 2023

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

A Phase 3 interventional study of Aspirin 81Mg Ec Tab and Clopidogrel in Dry Age-related Macular Degeneration, sponsored by Navamindradhiraj University. Recruiting at 1 site in Thailand. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-12-15.

Sponsored by Navamindradhiraj University · Phase 3, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
Phase
Phase 3
Study type
Interventional
Enrollment
174
Allocation
Non-randomized
Ages
50 Years to 85 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Dry Age-related Macular Degeneration
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's planned enrollment of 174 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Navamindradhiraj University is the lead sponsor of 14 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
174 participants (estimated)

Study arms

  • Active comparator
    Antiplatelet drug

    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 · Drug: Clopidogrel

  • Experimental
    Antiplatelet drug with antioxidant

    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 · Drug: Clopidogrel · Drug: N-acetylcysteine

  • No intervention
    No medication

    Patient with no medication used.

Interventions

  • DrugAspirin 81Mg Ec Tab

    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.

    Also known as: NAC-long

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 year

Secondary outcomes

  1. Best-corrected visual acuity change

    To evaluate Best-corrected visual acuity in each patient group by ETDRS chart

    Time frame: 1 year

  2. Rate of disease progression

    To evaluate disease progression to geographic atrophy or neovascular AMD by OCT scan and fundus photo

    Time frame: 1 year

  3. Side effects of medications intake

    To evaluate the safety of the medication used by questionnaire

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Department of ophthalmology, Faculty of medicine, Vajira hospital, Navamindradhiraj University
    Bangkok, Dusit 10300, Thailand
    Recruiting
08

References and documents

Study documents

  • Protocol, analysis plan and consent form · Mar 15, 2023

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06165068
Lead sponsor
Navamindradhiraj University
Responsible party
Yolradee Winuntamalakul (Principal Investigator, Navamindradhiraj University) — Principal investigator
First posted
Dec 11, 2023
Start date
Dec 2023 (estimated)
Primary completion
Dec 2025 (estimated)
Completion
Sep 2026 (estimated)
Last update
Dec 15, 2023

Study contacts

Yolradee Winuntamalakul
Contact
yolradee.win@nmu.ac.th
+66851283362

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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