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

NCT ID: NCT04187443

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-02
• Study Completion Date: 2026-12-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MS-553 low dose

low dose of MS-553 taken orally

Group Type: EXPERIMENTAL

MS-553

Intervention Type: DRUG

MS-553

MS-553 mid dose

mid dose of MS-553 taken orally

Group Type: EXPERIMENTAL

MS-553

Intervention Type: DRUG

MS-553

MS-553 high dose

high dose of MS-553 taken orally

Group Type: EXPERIMENTAL

MS-553

Intervention Type: DRUG

MS-553

Interventions

MS-553

MS-553

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fountain Medical Development Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kai Zhang, MD

Role: STUDY_DIRECTOR

Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.

Locations

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status: RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status: RECRUITING

Shanghai General Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Ling Yang

Role: CONTACT

yangling@relin.cn

+8613421382136

Other Identifiers

2019-001-CN

Identifier Type: -

Identifier Source: org_study_id