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

Last updated: March 28, 2025
Sponsor: Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Macular Edema

Diabetic Macular Edema

Diabetic Retinopathy

Treatment

MS-553

Clinical Study ID

NCT04187443
2019-001-CN
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of diabetes mellitus (type 1 or type 2) according to ADA or WHO diabeticdiagnosis criteria

  • Subject has the ability to follow the study instructions and is likely to completeall required study procedures and visits;

  • All males and females must consent to pregnancy prevention during the study andqualified measures of birth control. All females of childbearing potential mustconsent 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 coherencetomography (sd-OCT) of the central retina subfield thickness (CRT) at the ScreeningVisit (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 RetinopathyStudy (ETDRS) visual acuity protocol, and assessed at the Screening Visit Visualacuity (VA);

  • Confirmation by the investigator that laser photocoagulation and anti-VEGFtreatments are either declined by the patients or not needed and can be withheld forat least 3 months after the Screening Visit;

  • Ocular media and pupil dilation adequate to permit good quality retinal imaging asassessed at Screening Visit.

Exclusion

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 oroptic 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 ischemicattack, 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 safeadministration of the study medication, adherence to the scheduled study visits,safe participation in the study or affect the results of the study as assessed atScreening Visit;

Study Design

Total Participants: 45
Treatment Group(s): 1
Primary Treatment: MS-553
Phase: 1
Study Start date:
June 02, 2020
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan
    China

    Active - Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan
    China

    Active - Recruiting

  • Shanghai General Hospital

    Shanghai, 200080
    China

    Active - Recruiting

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