AzTrials
AzTrials

Diabetic Macular EdemaPhase 1NCT04187443

MS-553 in Diabetic Retinopathy Patients With Central Involved Macular Edema

A Phase 1 study testing MS-553 in people with Diabetic Macular Edema and Macular Edema, run by Shenzhen MingSight Relin Pharmaceuticals Co., Ltd. at 3 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is an open label dose-escalation study to evaluate the safety and treatment benefits of MS-553 in treatment-naive diabetic retinopathy patients with central involved macular edema. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MS-553
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
3 sitesChina
Study dates
2 Jun 2020to 30 Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • Diagnosis of diabetes mellitus (type 1 or type 2) according to ADA or WHO diabetic diagnosis criteria
  • Subject has the ability to follow the study instructions and is likely to complete all required study procedures and visits;
  • All males and females must consent to pregnancy prevention during the study and qualified measures of birth control. All females of childbearing potential must consent to a pregnancy test before entering the study.
  • Presence of central involved macular edema associated with diabetic retinopathy, i.e. diabetic macular edema (DME), as assessed by spectral domain optical coherence tomography (sd-OCT) of the central retina subfield thickness (CRT) at the Screening Visit (Centration must be confirmed by Investigators with signatures);
  • Best Corrected Visual Acuity (BCVA) score ≥ 34 letters (approximately 20/200 to 20/20 Snellen equivalent or better) using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity protocol, and assessed at the Screening Visit Visual acuity (VA);
  • Confirmation by the investigator that laser photocoagulation and anti-VEGF treatments are either declined by the patients or not needed and can be withheld for at least 3 months after the Screening Visit;
  • Ocular media and pupil dilation adequate to permit good quality retinal imaging as assessed at Screening Visit.

Who cannot join

  • Subjects with unstable metabolic or blood pressure control
  • Subject with emaciation or obesity at Screening Visit: body mass index (BMI) <18.5kg/m2 or >28kg/m2
  • Current use or likely need for medications know to be toxic to the lens, retina or optic nerve, including Deferoxamine, Chloroquine / hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambutol -
  • History of myocardial infarction or other cardiac event requiring hospitalization (unstable angina pectoris, etc.), cerebrovascular accident, transient ischemic attack, treatment for acute congestive heart failure or any arrhythmia within 4-months prior to Screening Visit;
  • Any situation that may in the opinion of the investigator preclude the safe administration of the study medication, adherence to the scheduled study visits, safe participation in the study or affect the results of the study as assessed at Screening Visit;

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ling Yang contact

+8613421382136

yangling@relin.cn

China3 sites, 3 recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

    Recruiting

  • Shanghai General Hospital

    Shanghai, 200080

    Xun Xu, MD

    Kun Liu, MD

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Open-label, Dose Escalation Study Assessing the Safety and Treatment Effects of MS-553 in Diabetic Retinopathy Patients With Central Involved Macular Edema

This is an open label dose-escalation study to evaluate the safety and treatment benefits of MS-553 in treatment-naive diabetic retinopathy patients with central involved macular edema. Fifteen subjects with diabetic macular edema will be enrolled into each of three dose cohorts and will receive oral administration of MS-553 for 8 weeks.

Being tested
MS-553
Keywords
Diabetic Macular Edema, Macular Edema, Center-involved Diabetic Macular Edema, Center-involved DME, DME, Diabetic Retinopathy
Medical subject headings
Macular Edema, Diabetic Retinopathy

What participants receive

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

  • MS-553Drug

    MS-553

Study groups in NCT04187443
Study groupRoleWhat they receive
MS-553 low doseExperimentallow dose of MS-553 taken orally
Receives: Drug: MS-553
MS-553 mid doseExperimentalmid dose of MS-553 taken orally
Receives: Drug: MS-553
MS-553 high doseExperimentalhigh dose of MS-553 taken orally
Receives: Drug: MS-553

What is being measured

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

  1. Treatment-emergent adverse events

    Measured: Baseline to Day 56

Secondary outcomes (5)

  1. Mean change in the central retina subfield thickness (CRT)

    Measured: Baseline to Day 56

  2. Mean change in the retinal volume

    Measured: Baseline to Day 56

  3. Proportion of patients with >20% reduction in CRT

    Measured: Baseline to Day 56

  4. Proportion of patients with resolution of central involved macular edema

    Measured: Baseline to Day 56

  5. Average mean change in best corrected visual acuity

    Measured: Baseline to Day 56

Timeline

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

  1. First posted5 Dec 2019
  2. Study start2 Jun 2020
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04187443
Sponsor's protocol ID
2019-001-CN
Status last verified
Sep 2025
First submitted
3 Dec 2019
Last updated
29 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MS-553 in people with Diabetic Macular Edema and Macular Edema, run by Shenzhen MingSight Relin Pharmaceuticals Co., Ltd. at 3 sites in China.

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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Ling Yang (+8613421382136, yangling@relin.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment-emergent adverse events (time frame: Baseline to Day 56). 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 NCT04187443.

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 29 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in