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

NCT ID: NCT06165068

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dry Age-related Macular Degeneration

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Aspirin 81Mg Ec Tab

Intervention Type DRUG

Patients take aspirin 81 mg per day.

Clopidogrel

Intervention Type DRUG

Patients take clopidogrel 75 mg per day.

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.

Group Type EXPERIMENTAL

Aspirin 81Mg Ec Tab

Intervention Type DRUG

Patients take aspirin 81 mg per day.

Clopidogrel

Intervention Type DRUG

Patients take clopidogrel 75 mg per day.

N-acetylcysteine

Intervention Type DRUG

Patients are given N-acetylcysteine 600 mg per day.

No medication

Patient with no medication used.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Aspirin 81Mg Ec Tab

Patients take aspirin 81 mg per day.

Intervention Type DRUG

Clopidogrel

Patients take clopidogrel 75 mg per day.

Intervention Type DRUG

N-acetylcysteine

Patients are given N-acetylcysteine 600 mg per day.

Intervention Type DRUG

Other Intervention Names

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NAC-long

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Navamindradhiraj University

OTHER

Sponsor Role lead

Responsible Party

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Yolradee Winuntamalakul

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Bangkok, Dusit, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Yolradee Winuntamalakul

Role: CONTACT

Phone: +66851283362

Email: [email protected]

Facility Contacts

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Yolradee Winuntamalakul

Role: primary

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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193/65 FB

Identifier Type: -

Identifier Source: org_study_id