Home Monitoring of Diabetic Macular Edema

March 30, 2023 updated by: Zhongshan Ophthalmic Center, Sun Yat-sen University
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Zhongshan Ophthalmic Center
        • Contact:
        • Principal Investigator:
          • Yingfeng Zheng

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:

  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
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in visual acuity
Time Frame: 12 weeks
Changes in visual acuity from baseline to 12 weeks adjusted for baseline visual acuity
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The costs of treatment
Time Frame: 12 weeks
The Cost-effectiveness between the two monitoring models
12 weeks
Number of intravitreal injections
Time Frame: 12 weeks
The number of intravitreal injections given per group
12 weeks
Gains or losses in visual acuity
Time Frame: 12 weeks
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
Time Frame: 12 weeks
central subfield thickness and retinal volume as measured by OCT after 12 weeks
12 weeks
Number of visits
Time Frame: 12 weeks
The number of visits during the study
12 weeks
Changes in visual acuity after 24 weeks
Time Frame: 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
Time Frame: 48 weeks
Changes in visual acuity from baseline to 48 weeks adjusted for baseline visual acuity
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhongshan Ophthalmic Center, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 3, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 12, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 4, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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