Home Monitoring of Diabetic Macular Edema

NCT05223569 | Unknown DMC

• 1 other identifier: 2021KYPJ099
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Changes in visual acuity

  Changes in visual acuity from baseline to 12 weeks adjusted for baseline visual acuity

  12 weeks

Secondary Outcomes (7)

• The costs of treatment

  12 weeks

• Number of intravitreal injections

  12 weeks

• Gains or losses in visual acuity

  12 weeks

• Central subfield thickness change as measured by optical coherence tomography

  12 weeks

• Number of visits

  12 weeks

Study Arms (2)

Home OCT monitoring model

EXPERIMENTAL

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

Device: Home OCT monitoring model

Hospital-based monitoring with a staff-administrated OCT

ACTIVE COMPARATOR

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

Interventions

Home OCT monitoring model DEVICE

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

Home OCT monitoring model

Hospital-based monitoring with a staff-administrated OCT DEVICE

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

Hospital-based monitoring with a staff-administrated OCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 31440424 BACKGROUND

• 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.

  PMID: 30050725 BACKGROUND

• 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.

  PMID: 29068914 BACKGROUND

• 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.

  PMID: 25590856 BACKGROUND

Central Study Contacts

Shida Chen, MD

CONTACT

13760849121; chenshd3@mail.sysu.edu.cn

Yingfeng Zheng, MD

CONTACT

13922286455; zhyfeng@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2022
• First Posted: February 4, 2022
• Study Start: March 3, 2022
• Primary Completion: December 12, 2023
• Study Completion: June 1, 2024
• Last Updated: April 4, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)