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

Sponsor

Shenzhen MingSight Relin Pharmaceuticals Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04187443

Collaborator

Fountain Medical Development Co., Ltd. (Industry)

Enrollment

Locations

Arms

28.5

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema Macular Edema Type 2 Diabetes With Diabetic Macular Edema Type 1 Diabetes With Diabetic Macular Edema Diabetic Retinopathy	Drug: MS-553	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 2, 2020

Anticipated Primary Completion Date :

Aug 18, 2022

Anticipated Study Completion Date :

Oct 18, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Treatment-emergent adverse events [Baseline to Day 56]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Second Xiangya Hospital of Central South University	Changsha	Hunan	China
2	West China Hospital of Sichuan University	Chengdu	Sichuan	China
3	Shanghai General Hospital	Shanghai		China	200080