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

December 11, 2023 updated by: Yolradee Winuntamalakul, Navamindradhiraj University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

174

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
    • Dusit
      • Bangkok, Dusit, Thailand, 10300
        • Recruiting
        • Department of ophthalmology, Faculty of medicine, Vajira hospital, Navamindradhiraj University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Patients take aspirin 81 mg per day.
Drug: Clopidogrel
Patients take clopidogrel 75 mg per day.
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
Patients take aspirin 81 mg per day.
Drug: Clopidogrel
Patients take clopidogrel 75 mg per day.
Drug: N-acetylcysteine
Patients are given N-acetylcysteine 600 mg per day.
Other Names:
  • NAC-long
No Intervention: No medication
Patient with no medication used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Navamindradhiraj University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

December 1, 2023

First Submitted That Met QC Criteria

December 1, 2023

First Posted (Actual)

December 11, 2023

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 193/65 FB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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