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

Diabetic Retinopathy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04187443
• Other study ID #: 2019-001-CN
• Status: Recruiting
• Phase: Phase 1
• Start date: June 2, 2020
• Est. completion date: January 31, 2024

Study information

• Verified date: March 2023
• Source: MingSight Pharmaceuticals, Inc
• Contact: Ling Yang
• Phone: +8613421382136
• Email: yangling[@]relin.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: January 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Macular Edema
• Diabetic Retinopathy
• Edema
• Macular Edema
• Retinal Diseases
• Type 1 Diabetes With Diabetic Macular Edema
• Type 2 Diabetes With Diabetic Macular Edema

Intervention

Drug:
• MS-553
MS-553

Locations

Country	Name	City	State
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Shanghai General Hospital	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.	Fountain Medical Development Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-emergent adverse events		Baseline to Day 56
Secondary	Mean change in the central retina subfield thickness (CRT)		Baseline to Day 56
Secondary	Mean change in the retinal volume		Baseline to Day 56
Secondary	Proportion of patients with >20% reduction in CRT		Baseline to Day 56
Secondary	Proportion of patients with resolution of central involved macular edema		Baseline to Day 56
Secondary	Average mean change in best corrected visual acuity		Baseline to Day 56