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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| No medication | No Intervention | Patient with no medication used. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin 81Mg Ec Tab | Drug | Patients take aspirin 81 mg per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Best-corrected visual acuity change | To evaluate Best-corrected visual acuity in each patient group by ETDRS chart | 1 year |
| Rate of disease progression | To evaluate disease progression to geographic atrophy or neovascular AMD by OCT scan and fundus photo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yolradee Winuntamalakul | Contact | +66851283362 | yolradee.win@nmu.ac.th |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of ophthalmology, Faculty of medicine, Vajira hospital, Navamindradhiraj University | Recruiting | Bangkok | Dusit | 10300 | Thailand |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 15, 2023 | Dec 1, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Clopidogrel | Drug | Patients take clopidogrel 75 mg per day. |
|
| N-acetylcysteine | Drug | Patients are given N-acetylcysteine 600 mg per day. |
|
|
| 1 year |
| Side effects of medications intake | To evaluate the safety of the medication used by questionnaire | 1 year |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |