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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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TCTR |
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Last refreshed on:
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1 April 2024 |
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Main ID: |
TCTR20161010005 |
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Date of registration:
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10/10/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A study of retinal microvascular changes in Diabetic Macular Edema using the swept - source optical coherence tomography angiography (OCTA) after being treated with Anti-Vascular endothelial growth factors (Anti-VEGF)
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Scientific title:
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A study of retinal microvascular changes in Diabetic Macular Edema using the swept – source optical coherence tomography angiography (OCTA) after being treated with Anti-Vascular endothelial growth factors (Anti-VEGF) |
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Date of first enrolment:
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17/10/2016 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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https://www.thaiclinicaltrials.org/show/TCTR20161010005 |
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Study type:
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Observational |
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Study design:
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Non-randomized
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Phase:
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Phase 3
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Contacts
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Name:
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Pear
Pongsacharoennont |
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Address:
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1873 Chulalongkorn Hospital, Rama 4 Rd, Patumwan, Bangkok 10330
10330
Bangkok
Thailand |
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Telephone:
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022564420 |
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Email:
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pearee@gmail.com |
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Affiliation:
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Faculty of Medicine, Chulalongkorn University |
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Name:
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Pear
Ponsacharoennont |
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Address:
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1873 Chulalongkorn Hospital, Rama 4 Rd, Patumwan, Bangkok 10330
10330
Bangkok
Thailand |
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Telephone:
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022564420 |
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Email:
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pearee@gmail.com |
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Affiliation:
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Faculty of Medicine, Chulalongkorn University |
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Key inclusion & exclusion criteria
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Inclusion criteria: - Patients diagnosed with Diabetic Macular Edema (DME).
- Age > 18 years of age who have signed an inform consent.
- Candidates to be treated with Intravitreous Anti-VEGF ( Aflibercept , Bevacizumab and Ranibizumab )
- No history of Anti-VEGF treatment within 3 months.
- No history of retina surgery.
Exclusion criteria: - Presence of severe media opacities.
- Patients who have other disease: monoculus, eye injuries , glaucoma, uveitis, retinal vein occlusion, retinal arterial occlusion, hereditary and degenerative macular disease, retinal and choroidal detachment.
- Any previous treatment for DME e.g. Focal / Grid LASER , IVT steroid injection/implant with in 6 months.
Age minimum:
18 Years
Age maximum:
0 N/A (No limit)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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DME
Microaneurysm changes
Enlarged FAZ Zone
Capillary non perfusion zone
Central-involved DME
OCTA
Microaneurysm change
Enlarged Foveal avascular zone
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Central-involved DME
OCTA
Microaneurysm change
Enlarged Foveal avascular zone
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Intervention(s)
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Treatment,Treatment,Treatment
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DME treated with Bevacizumab,DME treated with Aflibercept ,DME treated with Ranibizumab
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Primary Outcome(s)
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MIcroaneurysm in ETDRS Grid 1 year Image J Software
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Secondary Outcome(s)
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FAZ 1 year Image J ,Capillary non perfusion area 1 year Image J
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Source(s) of Monetary Support
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Ratchadapiseksompot Endowment Fund
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Ethics review
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Status: Submitted, approved
Approval date:
Contact:
Research Affairs Faculty of Medicine, Chulalongkorn University
022564493 Ext. 4493
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Results
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Results available:
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Date Posted:
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Date Completed:
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18/10/2017 |
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URL:
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