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

Phase 1

Recruiting

• Conditions: Type 1 Diabetes With Diabetic Macular Edema; Diabetic Retinopathy; Diabetic Macular Edema; Macular Edema; Type 2 Diabetes With Diabetic Macular Edema
• Interventions: Drug: MS-553

• Registration Number: NCT04187443
• Lead Sponsor: Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-05
• Study Start: 2020-06-02
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MS-553 mid dose	MS-553	mid dose of MS-553 taken orally
MS-553 low dose	MS-553	low dose of MS-553 taken orally
MS-553 high dose	MS-553	high dose of MS-553 taken orally

Primary Outcome Measures

Name	Time	Method
Treatment-emergent adverse events	Baseline to Day 56

Secondary Outcome Measures

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

Trial Locations

Locations (3)

The Second Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Shanghai General Hospital; 🇨🇳 Shanghai, China