Macular Edema Due to Diabetes MellitusNCT05223569

Home Monitoring of Diabetic Macular Edema

A study testing Home OCT monitoring model and Hospital-based monitoring with a staff-administrated OCT in people with Macular Edema Due to Diabetes Mellitus, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Macular Edema Due to Diabetes Mellitus
What is being tested?: Home OCT monitoring model and Hospital-based monitoring with a staff-administrated OCT
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteChina
Study dates: 3 Mar 2022to 1 Jun 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

Show all 9Show fewer

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.

Who cannot join

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);

Show all 9Show fewer

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;

Trial locations and contacts

1 site in 1 country.

Shida Chen, MD contact

13760849121

chenshd3@mail.sysu.edu.cn

Yingfeng Zheng, MD contact

13922286455

zhyfeng@mail.sysu.edu.cn

China1 site, 1 recruiting

Zhongshan Ophthalmic Center
Guangzhou, Guangdong, 510060
shida chen, +862066683995, chenshd3@mail.sysu.edu.cn
yingfeng Zheng, +862066683995, zhyfeng@mail.sysu.edu.cn
Recruiting

Other trials in China

About this study

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
Being tested: Home OCT monitoring model, Hospital-based monitoring with a staff-administrated OCT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05223569
Study group	Role	What they receive
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 Receives: 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. Receives: Device: Hospital-based monitoring with a staff-administrated OCT

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (7)

The costs of treatment
The Cost-effectiveness between the two monitoring models
Measured: 12 weeks
Number of intravitreal injections
The number of intravitreal injections given per group
Measured: 12 weeks
Gains or losses in visual acuity
The proportion of eyes with two- and three-line gains or losses in visual acuity
Measured: 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
Measured: 12 weeks
Number of visits
The number of visits during the study
Measured: 12 weeks
Changes in visual acuity after 24 weeks
Changes in visual acuity from baseline to 24 weeks adjusted for baseline visual acuity
Measured: 24 weeks
Changes in visual acuity after 48 weeks
Changes in visual acuity from baseline to 48 weeks adjusted for baseline visual acuity
Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Mar 20221 Jun 2024

First posted4 Feb 2022
Study start3 Mar 2022
Primary completion12 Dec 2023 (estimated)
Study completion1 Jun 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Macular Edema Due to Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05223569
Sponsor's protocol ID: 2021KYPJ099
Status last verified: Feb 2023
First submitted: 22 Jan 2022
Last updated: 4 Apr 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 31440424
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.
PubMed 30050725
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.
PubMed 29068914
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.
PubMed 25590856

Want to know more?

Shida Chen, MD

13760849121

chenshd3@mail.sysu.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME

All Macular Edema Due to Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Home Monitoring of Diabetic Macular Edema
ClinicalTrials.gov ID: NCT05223569
Acronym / sponsor ID: 2021KYPJ099
Conditions: Macular Edema Due to Diabetes Mellitus
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 120 participants (estimated)
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
Study start: 3 Mar 2022 (actual)
Primary completion: 12 Dec 2023 (estimated)
Study completion: 1 Jun 2024 (estimated)
First posted: 4 Feb 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Home OCT monitoring model	Experimental	Device: Home OCT monitoring modelParticipants 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
Hospital-based monitoring with a staff-administrated OCT	Active comparator	Device: Hospital-based monitoring with a staff-administrated OCTParticipants will be instructed to come back to the clinic to receive traditional OCT and VA examinations operated by the study coordinators every month.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Age ≥18 years;
Diagnosis of diabetic 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;

Key exclusion criteria (9 listed)

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.);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Home OCT monitoring modelA home monitoring set, which includes a self-administrated OCT, and a self-administrated smartphone-based visual acuity tester	Device	Home OCT monitoring model
Hospital-based monitoring with a staff-administrated OCTParticipants come back to the clinic to receive traditional OCT and VA examinations operated by the study coordinators	Device	Hospital-based monitoring with a staff-administrated OCT

Primary outcome

Changes in visual acuity
Time frame: 12 weeks
Changes in visual acuity from baseline to 12 weeks adjusted for baseline visual acuity

7 secondary outcomes

The costs of treatment
Time frame: 12 weeks
Number of intravitreal injections
Time frame: 12 weeks
Gains or losses in visual acuity
Time frame: 12 weeks
Central subfield thickness change as measured by optical coherence tomography
Time frame: 12 weeks
Number of visits
Time frame: 12 weeks
Changes in visual acuity after 24 weeks
Time frame: 24 weeks
Changes in visual acuity after 48 weeks
Time frame: 48 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
Background: PubMed 31440424Han 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.
Background: PubMed 30050725Maloca 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.
Background: PubMed 29068914Weiss 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.
Background: PubMed 25590856Jusufbegovic 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.
Individual participant dataSharing planned: No

Related trials for Macular Edema Due to Diabetes Mellitus

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shida Chen, MD contact

13760849121

chenshd3@mail.sysu.edu.cn

Yingfeng Zheng, MD contact

13922286455

zhyfeng@mail.sysu.edu.cn

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shida Chen, MD (13760849121, chenshd3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in visual acuity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05223569, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.