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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Retinopathy; Diabetic Macular Edema; Macular Edema; Type 2 Diabetes With Diabetic Macular Edema; Type 1 Diabetes With Diabetic Macular Edema
• Intervention / Treatment: Drug: MS-553

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ling Yang; Phone Number: +8613421382136; Email: yangling@relin.cn

Study Locations

• China
  • Shanghai, China, 200080
    • Recruiting
    • Shanghai General Hospital
    • Principal Investigator: Xun Xu, MD
    • Principal Investigator: Kun Liu, MD
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • The second Xiangya hospital of central south university
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • West China Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Treatment-emergent adverse events	Baseline to Day 56

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean change in the central retina subfield thickness (CRT)	Baseline to Day 56
Mean change in the retinal volume	Baseline to Day 56
Proportion of patients with >20% reduction in CRT	Baseline to Day 56
Proportion of patients with resolution of central involved macular edema	Baseline to Day 56
Average mean change in best corrected visual acuity	Baseline to Day 56

Collaborators and Investigators

• Sponsor: Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.
• Collaborators: Fountain Medical Development Co., Ltd.
• Investigators: Study Director: Kai Zhang, MD, Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2020
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: December 3, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (Actual): December 5, 2019

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Diabetic Macular Edema; Diabetic Retinopathy; Macular Edema; DME; Center-involved Diabetic Macular Edema; Center-involved DME
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Eye Diseases; Diabetic Angiopathies; Diabetes Complications; Retinal Diseases; Retinal Degeneration; Macular Degeneration; Diabetic Retinopathy; Macular Edema
• Other Study ID Numbers: 2019-001-CN

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
• product manufactured in and exported from the U.S.: No