Status:
UNKNOWN
Home Monitoring of Diabetic Macular Edema
Lead Sponsor:
Zhongshan Ophthalmic Center, Sun Yat-sen University
Conditions:
Macular Edema Due to Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Diabetic macular edema (DME) is part of diabetic retinopathy (DR) and a leading cause of central visual loss in people with diabetes . Most patients require pharmacological inhibition using anti-vascu...
Eligibility Criteria
Inclusion
- Age ≥18 years;
- Diagnosis of diabetic macular edema:
- Type 1 or type 2 diabetes mellitus;
- Center-involved macular edema;
- Willing to receive anti-VEGF treatment;
- Media clarity, pupillary dilation, and individual cooperation sufficient for adequate OCT examination;
- Able to operate self-administratedhome OCT by themselves or with the help of family;
- Travel time from home to hospital: within 2 hours driving.
- Able and willing to provide informed consent.
Exclusion
- History of systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization. (These drugs should not be used during the study);
- History of corticosteroid treatment (intravitreal or peribulbar) at any time in the past 4 months;
- History of macular laser photocoagulation in the past 4 months;
- Macular edema due to reasons other than diabetes;
- Coexisting ocular diseases that might alter visual acuity during the course of the study, such as retinal vein or artery occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.);
- Hypertension (systolic blood pressure (BP) above 180 or diastolic BP above 110);
- History of myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization;
- Pregnant or lactating;
- Currently participating in other clinical trials;
Key Trial Info
Start Date :
March 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05223569
Start Date
March 3 2022
End Date
June 1 2024
Last Update
April 4 2023
Active Locations (1)
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1
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, China, 510060