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.
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
- Conditions the study is for
- Diabetic Macular Edema, Macular Edema, Type 2 Diabetes With Diabetic Macular Edema
- 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
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.
China3 sites, 3 recruiting
- 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
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.
- Conditions
- Diabetic Macular Edema, Macular Edema, Type 2 Diabetes With Diabetic Macular Edema, Type 1 Diabetes With Diabetic Macular Edema, Diabetic Retinopathy
- 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 group | Role | What they receive |
|---|---|---|
| MS-553 low dose | Experimental | low dose of MS-553 taken orally Receives: Drug: MS-553 |
| MS-553 mid dose | Experimental | mid dose of MS-553 taken orally Receives: Drug: MS-553 |
| MS-553 high dose | Experimental | high 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.
Treatment-emergent adverse events
Measured: Baseline to Day 56
Secondary outcomes (5)
Mean change in the central retina subfield thickness (CRT)
Measured: Baseline to Day 56
Mean change in the retinal volume
Measured: Baseline to Day 56
Proportion of patients with >20% reduction in CRT
Measured: Baseline to Day 56
Proportion of patients with resolution of central involved macular edema
Measured: Baseline to Day 56
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.
- First posted5 Dec 2019
- Study start2 Jun 2020
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fountain Medical Development Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Kai Zhang, MD, Study director, Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.
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