Home Monitoring of Diabetic Macular Edema

NCT ID: NCT05223569

Last Updated: 2023-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-03
• Study Completion Date: 2024-06-01

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.

Conditions

Macular Edema Due to Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Home OCT monitoring model

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:

1. Smartphone-assisted online instruction provided by a virtual specialist

2. Visual acuity self test using a smartphone

3. Self-testing OCT imaging

Group Type: EXPERIMENTAL

Home OCT monitoring model

Intervention Type: DEVICE

A home monitoring set, which includes a self-administrated OCT, and a self-administrated smartphone-based visual acuity tester

Hospital-based monitoring with a staff-administrated OCT

Participants will be instructed to come back to the clinic to receive traditional OCT and VA examinations operated by the study coordinators every month.

Group Type: ACTIVE_COMPARATOR

Hospital-based monitoring with a staff-administrated OCT

Intervention Type: DEVICE

Participants come back to the clinic to receive traditional OCT and VA examinations operated by the study coordinators

Interventions

Home OCT monitoring model

A home monitoring set, which includes a self-administrated OCT, and a self-administrated smartphone-based visual acuity tester

Intervention Type: DEVICE

Hospital-based monitoring with a staff-administrated OCT

Participants come back to the clinic to receive traditional OCT and VA examinations operated by the study coordinators

Intervention Type: DEVICE

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shida Chen, MD

Role: CONTACT

chenshd3@mail.sysu.edu.cn

13760849121

Yingfeng Zheng, MD

Role: CONTACT

zhyfeng@mail.sysu.edu.cn

13922286455

Facility Contacts

shida chen

Role: primary

chenshd3@mail.sysu.edu.cn

+862066683995

yingfeng Zheng

Role: backup

zhyfeng@mail.sysu.edu.cn

+862066683995

References

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.

Reference Type: BACKGROUND

PMID: 31440424 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30050725 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29068914 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25590856 (View on PubMed)

Other Identifiers

2021KYPJ099

Identifier Type: -

Identifier Source: org_study_id