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

NCT04187443 | Recruiting Phase 1

• 1 other identifier: 2019-001-CN
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

Brief 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. 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

Keywords

Diabetic Macular Edema; Macular Edema; Center-involved Diabetic Macular Edema; Center-involved DME; DME; Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• Treatment-emergent adverse events

  Baseline to Day 56

Secondary Outcomes (5)

• 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

Study Arms (3)

MS-553 low dose

EXPERIMENTAL

low dose of MS-553 taken orally

Drug: MS-553

MS-553 mid dose

EXPERIMENTAL

mid dose of MS-553 taken orally

Drug: MS-553

MS-553 high dose

EXPERIMENTAL

high dose of MS-553 taken orally

Drug: MS-553

Interventions

MS-553 DRUG

MS-553

MS-553 high dose; MS-553 low dose; MS-553 mid dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.: lead
• Fountain Medical Development Co., Ltd.: collaborator

Study Sites (3)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

Shanghai General Hospital

Shanghai, 200080, China

RECRUITING

MeSH Terms

Conditions

Macular Edema; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Kai Zhang, MD

  Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Ling Yang

CONTACT

+8613421382136; yangling@relin.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 5, 2019
• Study Start: June 2, 2020
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)