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Home Monitoring of Diabetic Macular Edema

Primary Purpose

Macular Edema Due to Diabetes Mellitus

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Home OCT monitoring model

Hospital-based monitoring with a staff-administrated OCT

About this trial

This is an interventional treatment trial for Macular Edema Due to Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

Zhongshan Ophthalmic CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Home OCT monitoring model

Hospital-based monitoring with a staff-administrated OCT

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in visual acuity

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

Secondary Outcome Measures

The costs of treatment

The Cost-effectiveness between the two monitoring models

Number of intravitreal injections

The number of intravitreal injections given per group

Gains or losses in visual acuity

The proportion of eyes with two- and three-line gains or losses in visual acuity

Central subfield thickness change as measured by optical coherence tomography

central subfield thickness and retinal volume as measured by OCT after 12 weeks

Number of visits

The number of visits during the study

Changes in visual acuity after 24 weeks

Changes in visual acuity from baseline to 24 weeks adjusted for baseline visual acuity

Changes in visual acuity after 48 weeks

Changes in visual acuity from baseline to 48 weeks adjusted for baseline visual acuity

Full Information

NCT ID

NCT05223569

First Posted

January 22, 2022

Last Updated

March 30, 2023

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT05223569

Brief Title

Home Monitoring of Diabetic Macular Edema

Official Title

Home Monitoring of Diabetic Macular Edema

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 3, 2022 (Actual)

Primary Completion Date

December 12, 2023 (Anticipated)

Study Completion Date

June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Macular Edema Due to Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Home OCT monitoring model

Arm Type

Experimental

Arm Description

Arm Title

Hospital-based monitoring with a staff-administrated OCT

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Home OCT monitoring model

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Hospital-based monitoring with a staff-administrated OCT

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes in visual acuity

Description

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

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

The costs of treatment

Description

The Cost-effectiveness between the two monitoring models

Time Frame

12 weeks

Title

Number of intravitreal injections

Description

The number of intravitreal injections given per group

Time Frame

12 weeks

Title

Gains or losses in visual acuity

Description

The proportion of eyes with two- and three-line gains or losses in visual acuity

Time Frame

12 weeks

Title

Central subfield thickness change as measured by optical coherence tomography

Description

central subfield thickness and retinal volume as measured by OCT after 12 weeks

Time Frame

12 weeks

Title

Number of visits

Description

The number of visits during the study

Time Frame

12 weeks

Title

Changes in visual acuity after 24 weeks

Description

Changes in visual acuity from baseline to 24 weeks adjusted for baseline visual acuity

Time Frame

24 weeks

Title

Changes in visual acuity after 48 weeks

Description

Changes in visual acuity from baseline to 48 weeks adjusted for baseline visual acuity

Time Frame

48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shida Chen, MD

Phone

13760849121

chenshd3@mail.sysu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Yingfeng Zheng, MD

Phone

13922286455

zhyfeng@mail.sysu.edu.cn

Facility Information:

Facility Name

Zhongshan Ophthalmic Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

shida chen

Phone

+862066683995

chenshd3@mail.sysu.edu.cn

First Name & Middle Initial & Last Name & Degree

yingfeng Zheng

Phone

+862066683995

zhyfeng@mail.sysu.edu.cn

First Name & Middle Initial & Last Name & Degree

Yingfeng Zheng

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31440424

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.

Results Reference

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PubMed Identifier

30050725

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.

Results Reference

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PubMed Identifier

29068914

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.

Results Reference

background

PubMed Identifier

25590856

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.

Results Reference

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Home Monitoring of Diabetic Macular Edema

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