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NCT Number: NCT06165068

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

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.

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Key information

Conditions

Dry Age-related Macular Degeneration

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of ophthalmology, Faculty of medicine, Vajira hospital, Navamindradhiraj University

Bangkok, Dusit, 10300, Thailand

Location status: Recruiting

Location contact

Yolradee Winuntamalakul

CONTACT

[email protected]

+6622443874

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aspirin 81Mg Ec Tab

Drug

Patients take aspirin 81 mg per day.

clopidogrel

Drug

Patients take clopidogrel 75 mg per day.

N-acetylcysteine

Drug

Patients are given N-acetylcysteine 600 mg per day.

Other names: NAC-long

Primary outcomes

  1. Drusen volume analysis

    Time frame: 1 year

    To assess AMD progression in patient with large drusen, drusen volume was measured and analyzed in each patient group by OCT scan

Secondary outcomes

  1. Best-corrected visual acuity change

    Time frame: 1 year

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

  2. Rate of disease progression

    Time frame: 1 year

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

  3. Side effects of medications intake

    Time frame: 1 year

    To evaluate the safety of the medication used by questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Yolradee Winuntamalakul

CONTACT

[email protected]

+66851283362

Sponsors and collaborators

Lead sponsor

Navamindradhiraj University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Dec 11, 2023
Registry last updated
Dec 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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