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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50-85
SponsorNavamindradhiraj University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

174 Participants
are divided into 3 treatment groups
Group A: Antiplatelet drugActive comparator 2 interventions
Group B: Antiplatelet drug with antioxidantExperimental treatment 3 interventions
Group C: No medicationNo intervention 0 interventions

Trial outcomes

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

Time frame
1 year

Secondary outcomes

1

Best-corrected visual acuity change

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

Time frame
1 year
2

Rate of disease progression

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

Time frame
1 year
3

Side effects of medications intake

To evaluate the safety of the medication used by questionnaire

Time frame
1 year

Other outcomes

Sponsors and contacts

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