MS-553 in Diabetic Retinopathy Patients With Central Involved Macular Edema
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ClinicalTrials.gov Identifier: NCT04187443 |
Recruitment Status :
Recruiting
First Posted : December 5, 2019
Last Update Posted : March 15, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Macular Edema Macular Edema Type 2 Diabetes With Diabetic Macular Edema Type 1 Diabetes With Diabetic Macular Edema Diabetic Retinopathy | Drug: MS-553 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 45 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | June 2, 2020 |
Estimated Primary Completion Date : | December 31, 2023 |
Estimated Study Completion Date : | January 31, 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: MS-553 low dose
low dose of MS-553 taken orally
|
Drug: MS-553
MS-553 |
Experimental: MS-553 mid dose
mid dose of MS-553 taken orally
|
Drug: MS-553
MS-553 |
Experimental: MS-553 high dose
high dose of MS-553 taken orally
|
Drug: MS-553
MS-553 |
- Treatment-emergent adverse events [ Time Frame: Baseline to Day 56 ]
- Mean change in the central retina subfield thickness (CRT) [ Time Frame: Baseline to Day 56 ]
- Mean change in the retinal volume [ Time Frame: Baseline to Day 56 ]
- Proportion of patients with >20% reduction in CRT [ Time Frame: Baseline to Day 56 ]
- Proportion of patients with resolution of central involved macular edema [ Time Frame: Baseline to Day 56 ]
- Average mean change in best corrected visual acuity [ Time Frame: Baseline to Day 56 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04187443
Contact: Ling Yang | +8613421382136 | yangling@relin.cn |
China, Hunan | |
The Second Xiangya Hospital of Central South University | Recruiting |
Changsha, Hunan, China | |
China, Sichuan | |
West China Hospital of Sichuan University | Recruiting |
Chengdu, Sichuan, China | |
China | |
Shanghai General Hospital | Recruiting |
Shanghai, China, 200080 | |
Principal Investigator: Xun Xu, MD | |
Principal Investigator: Kun Liu, MD |
Study Director: | Kai Zhang, MD | Shenzhen MingSight Relin Pharmaceuticals Co., Ltd. |
Responsible Party: | Shenzhen MingSight Relin Pharmaceuticals Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT04187443 |
Other Study ID Numbers: |
2019-001-CN |
First Posted: | December 5, 2019 Key Record Dates |
Last Update Posted: | March 15, 2023 |
Last Verified: | March 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Diabetic Macular Edema Macular Edema Center-involved Diabetic Macular Edema |
Center-involved DME DME Diabetic Retinopathy |
Macular Edema Retinal Diseases Diabetic Retinopathy Diabetes Mellitus Edema Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Macular Degeneration Retinal Degeneration Eye Diseases Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications |