Home Monitoring of Diabetic Macular Edema

Study Overview
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Brief Summary
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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-vascular endothelial growth factor (VEGF) agents with multiple monitoring visits that include optical coherence tomography (OCT), visual acuity test, and multiple injections.The substantial visit frequency puts pressure on ophthalmic clinics, and can impose a tremendous burden on both patients and their caregivers. Therefore, self-service examination instruments that can be portable and fast-moving become the key for realizing tele-medicine. Recently, the investigators have developed a portable, self-administrated home OCT machine, which is designed for home-based OCT scanning and monitoring for patients with retinal diseases including DME, age related macular degeneration (AMD) and choroidal neovascularization (CNV) that require multiple anti-VEGF injections. The investigators have confirmed its image quality and validated the retinal thickness measurements obtained from this device by comparing with hospital OCT (staff-administrated and clinic-based).In this study, the investigators will conduct a randomized clinical trial (RCT) to compare the efficacy and cost-effectiveness of a home OCT monitoring model versus standard hospital care model for patients with diabetic macular edema who need anti-VEGF injections.

Official Title
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Home Monitoring of Diabetic Macular Edema

Conditions
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Macular Edema Due to Diabetes Mellitus

Intervention / Treatment
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* Device: Home OCT monitoring model
* Device: Hospital-based monitoring with a staff-administrated OCT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home OCT monitoring model<br>Participants will receive a home monitoring set, which includes a self-administrated OCT, and a self-administrated smartphone-based visual acuity tester. For each home service, participants will undergo the following: Smartphone-assisted online instruction provided by a virtual specialist Visual acuity self test using a smartphone Self-testing OCT imaging | Device: Home OCT monitoring model<br>* A home monitoring set, which includes a self-administrated OCT, and a self-administrated smartphone-based visual acuity tester<br>|
| Active Comparator: Hospital-based monitoring with a staff-administrated OCT<br>Participants will be instructed to come back to the clinic to receive traditional OCT and VA examinations operated by the study coordinators every month. | Device: Hospital-based monitoring with a staff-administrated OCT<br>* Participants come back to the clinic to receive traditional OCT and VA examinations operated by the study coordinators<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in visual acuity | Changes in visual acuity from baseline to 12 weeks adjusted for baseline visual acuity | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The costs of treatment | The Cost-effectiveness between the two monitoring models | 12 weeks | 
| Number of intravitreal injections | The number of intravitreal injections given per group | 12 weeks | 
| Gains or losses in visual acuity | The proportion of eyes with two- and three-line gains or losses in visual acuity | 12 weeks | 
| Central subfield thickness change as measured by optical coherence tomography | central subfield thickness and retinal volume as measured by OCT after 12 weeks | 12 weeks | 
| Number of visits | The number of visits during the study | 12 weeks | 
| Changes in visual acuity after 24 weeks | Changes in visual acuity from baseline to 24 weeks adjusted for baseline visual acuity | 24 weeks | 
| Changes in visual acuity after 48 weeks | Changes in visual acuity from baseline to 48 weeks adjusted for baseline visual acuity | 48 weeks |