Home Monitoring of Diabetic Macular Edema

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.

Study Overview

• Status: Recruiting
• Conditions: Macular Edema Due to Diabetes Mellitus
• Intervention / Treatment: Device: Hospital-based monitoring with a staff-administrated OCT; Device: Home OCT monitoring model

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shida Chen, MD; Phone Number: 13760849121; Email: chenshd3@mail.sysu.edu.cn
• Study Contact Backup: Name: Yingfeng Zheng, MD; Phone Number: 13922286455; Email: zhyfeng@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Zhongshan Ophthalmic Center
      • Contact: yingfeng Zheng; Phone Number: +862066683995; Email: zhyfeng@mail.sysu.edu.cn
      • Principal Investigator: Yingfeng Zheng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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
Experimental: 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: 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; A home monitoring set, which includes a self-administrated OCT, and a self-administrated smartphone-based visual acuity tester

What is the study measuring?

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2022
• Primary Completion (Anticipated): December 12, 2023
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: January 22, 2022
• First Submitted That Met QC Criteria: February 3, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema
• Other Study ID Numbers: 2021KYPJ099

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No