Dry Age-related Macular DegenerationPhase 3NCT06165068
Effects of Antiplatelet and Antioxidant Agents on Drusen Progression: A Pilot, Prospective Cohort Study
A Phase 3 study testing Aspirin 81Mg Ec Tab, Clopidogrel and N-acetylcysteine in people with Dry Age-related Macular Degeneration, run by Navamindradhiraj University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Dry Age-related Macular Degeneration
- What is being tested?
- Aspirin 81Mg Ec Tab, Clopidogrel and N-acetylcysteine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2023to Sep 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Department of ophthalmology, Faculty of medicine, Vajira hospital, Navamindradhiraj University
Bangkok, Dusit, 10300
Yolradee Winuntamalakul, +6622443874, yolradee.win@nmu.ac.th
About this 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.
- Conditions
- Dry Age-related Macular Degeneration
- Being tested
- Aspirin 81Mg Ec Tab, Clopidogrel, N-acetylcysteine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 81Mg Ec TabDrug
Patients take aspirin 81 mg per day.
ClopidogrelDrug
Patients take clopidogrel 75 mg per day.
N-acetylcysteineDrug
Also called NAC-long
Patients are given N-acetylcysteine 600 mg per day.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Aspirin 81Mg Ec Tab; Drug: Clopidogrel; Drug: N-acetylcysteine |
| No medication | No intervention | Patient with no medication used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (3)
Best-corrected visual acuity change
To evaluate Best-corrected visual acuity in each patient group by ETDRS chart
Measured: 1 year
Rate of disease progression
To evaluate disease progression to geographic atrophy or neovascular AMD by OCT scan and fundus photo
Measured: 1 year
Side effects of medications intake
To evaluate the safety of the medication used by questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study startDec 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Navamindradhiraj University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yolradee Winuntamalakul, Navamindradhiraj University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165068
- Sponsor's protocol ID
- 193/65 FB
- Status last verified
- Dec 2023
- First submitted
- 1 Dec 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Antiplatelet and Antioxidant Agents on Drusen Progression: A Pilot, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06165068
- Acronym / sponsor ID
- 193/65 FB
- Conditions
- Dry Age-related Macular Degeneration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Navamindradhiraj UniversityUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Antiplatelet drug | Active comparator | Drug: Aspirin 81Mg Ec Tab, Drug: ClopidogrelIn 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. |
| Antiplatelet drug with antioxidant | Experimental | Drug: Aspirin 81Mg Ec Tab, Drug: Clopidogrel, Drug: N-acetylcysteineAntiplatelet 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. |
| No medication | No intervention | –Patient with no medication used. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin 81Mg Ec TabPatients take aspirin 81 mg per day. | Drug | Antiplatelet drug, Antiplatelet drug with antioxidant |
| ClopidogrelPatients take clopidogrel 75 mg per day. | Drug | Antiplatelet drug, Antiplatelet drug with antioxidant |
| N-acetylcysteineAlso: NAC-longPatients are given N-acetylcysteine 600 mg per day. | Drug | Antiplatelet drug with antioxidant |
Primary outcome
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
3 secondary outcomes
Best-corrected visual acuity change
Time frame: 1 year
Rate of disease progression
Time frame: 1 year
Side effects of medications intake
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aspirin 81Mg Ec Tab, Clopidogrel and N-acetylcysteine in people with Dry Age-related Macular Degeneration, run by Navamindradhiraj University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yolradee Winuntamalakul (+66851283362, yolradee.win@nmu.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drusen volume analysis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.