Clinical trial NCT05223569: Home Monitoring of Diabetic Macular Edema
Official title: Home Monitoring of Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Macular Edema Due to Diabetes Mellitus
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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-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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years;
2. Diagnosis of diabetic macular edema:

   * Type 1 or type 2 diabetes mellitus;
   * Center-involved macular edema;
3. Willing to receive anti-VEGF treatment;
4. Media clarity, pupillary dilation, and individual cooperation sufficient for adequate OCT examination;
5. Able to operate self-administratedhome OCT by themselves or with the help of family;
6. Travel time from home to hospital: within 2 hours driving.
7. Able and willing to provide informed consent.

Exclusion Criteria:

1. History of systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization. (These drugs should not be used during the study);
2. History of corticosteroid treatment (intravitreal or peribulbar) at any time in the past 4 months;
3. History of macular laser photocoagulation in the past 4 months;
4. Macular edema due to reasons other than diabetes;
5. 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.);
6. Hypertension (systolic blood pressure (BP) above 180 or diastolic BP above 110);
7. 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;
8. Pregnant or lactating;
9. Currently participating in other clinical trials;

Primary outcomes:
measure: Changes in visual acuity
timeFrame: 12 weeks
Secondary outcomes:
measure: The costs of treatment
timeFrame: 12 weeks
measure: Number of intravitreal injections
timeFrame: 12 weeks
measure: Gains or losses in visual acuity
timeFrame: 12 weeks
measure: Central subfield thickness change as measured by optical coherence tomography
timeFrame: 12 weeks
measure: Number of visits
timeFrame: 12 weeks
measure: Changes in visual acuity after 24 weeks
timeFrame: 24 weeks
measure: Changes in visual acuity after 48 weeks
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
References:
citation: Han X, Scheetz J, Keel S, Liao C, Liu C, Jiang Y, Muller A, Meng W, He M. Development and Validation of a Smartphone-Based Visual Acuity Test (Vision at Home). Transl Vis Sci Technol. 2019 Aug 19;8(4):27. doi: 10.1167/tvst.8.4.27. eCollection 2019 Jul.
citation: Maloca P, Hasler PW, Barthelmes D, Arnold P, Matthias M, Scholl HPN, Gerding H, Garweg J, Heeren T, Balaskas K, de Carvalho JER, Egan C, Tufail A, Zweifel SA. Safety and Feasibility of a Novel Sparse Optical Coherence Tomography Device for Patient-Delivered Retina Home Monitoring. Transl Vis Sci Technol. 2018 Jul 24;7(4):8. doi: 10.1167/tvst.7.4.8. eCollection 2018 Jul.
citation: Weiss M, Sim DA, Herold T, Schumann RG, Liegl R, Kern C, Kreutzer T, Schiefelbein J, Rottmann M, Priglinger S, KortUEm KU. COMPLIANCE AND ADHERENCE OF PATIENTS WITH DIABETIC MACULAR EDEMA TO INTRAVITREAL ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR THERAPY IN DAILY PRACTICE. Retina. 2018 Dec;38(12):2293-2300. doi: 10.1097/IAE.0000000000001892.
citation: Jusufbegovic D, Mugavin MO, Schaal S. EVOLUTION OF CONTROLLING DIABETIC RETINOPATHY: Changing Trends in the Management of Diabetic Macular Edema at a Single Institution Over the Past Decade. Retina. 2015 May;35(5):929-34. doi: 10.1097/IAE.0000000000000438.