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

NCT06165068 | Recruiting Phase 3 DMC

• 1 other identifier: 193/65 FB
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Age-related Macular Degeneration

Outcome Measures

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

  1 year

Secondary Outcomes (3)

• Best-corrected visual acuity change

  1 year

• Rate of disease progression

  1 year

• Side effects of medications intake

  1 year

Study Arms (3)

Antiplatelet drug

ACTIVE COMPARATOR

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

Antiplatelet drug with antioxidant

EXPERIMENTAL

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 medication

NO INTERVENTION

Patient with no medication used.

Interventions

Aspirin 81Mg Ec Tab DRUG

Patients take aspirin 81 mg per day.

Antiplatelet drug; Antiplatelet drug with antioxidant

Clopidogrel DRUG

Patients take clopidogrel 75 mg per day.

Antiplatelet drug; Antiplatelet drug with antioxidant

N-acetylcysteine DRUG

Patients are given N-acetylcysteine 600 mg per day.

Also known as: NAC-long

Antiplatelet drug with antioxidant

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Navamindradhiraj University: lead

Study Sites (1)

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

Bangkok, Dusit, 10300, Thailand

RECRUITING

MeSH Terms

Interventions

Aspirin; Clopidogrel; Acetylcysteine

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Cysteine; Amino Acids, Sulfur; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Yolradee Winuntamalakul

CONTACT

+66851283362; yolradee.win@nmu.ac.th

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 11, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 15, 2023

Record last verified: 2023-12

Locations

TH (1)