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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04187443
Recruitment Status : Recruiting
First Posted : December 5, 2019
Last Update Posted : March 15, 2023
Sponsor:
Collaborator:
Fountain Medical Development Co., Ltd.
Information provided by (Responsible Party):
MingSight Pharmaceuticals, Inc ( Shenzhen MingSight Relin Pharmaceuticals Co., Ltd. )

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Treatment-emergent adverse events [ Time Frame: Baseline to Day 56 ]

Secondary Outcome Measures :
  1. Mean change in the central retina subfield thickness (CRT) [ Time Frame: Baseline to Day 56 ]
  2. Mean change in the retinal volume [ Time Frame: Baseline to Day 56 ]
  3. Proportion of patients with >20% reduction in CRT [ Time Frame: Baseline to Day 56 ]
  4. Proportion of patients with resolution of central involved macular edema [ Time Frame: Baseline to Day 56 ]
  5. Average mean change in best corrected visual acuity [ Time Frame: Baseline to Day 56 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04187443


Contacts
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Contact: Ling Yang +8613421382136 yangling@relin.cn

Locations
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China, Hunan
The Second Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China
China, Sichuan
West China Hospital of Sichuan University Recruiting
Chengdu, Sichuan, China
China
Shanghai General Hospital Recruiting
Shanghai, China, 200080
Principal Investigator: Xun Xu, MD         
Principal Investigator: Kun Liu, MD         
Sponsors and Collaborators
Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.
Fountain Medical Development Co., Ltd.
Investigators
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Study Director: Kai Zhang, MD Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.
More Information
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Responsible Party: Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT04187443    
Other Study ID Numbers: 2019-001-CN
First Posted: December 5, 2019    Key Record Dates
Last Update Posted: March 15, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by MingSight Pharmaceuticals, Inc ( Shenzhen MingSight Relin Pharmaceuticals Co., Ltd. ):
Diabetic Macular Edema
Macular Edema
Center-involved Diabetic Macular Edema
 Center-involved DME
DME
Diabetic Retinopathy
Additional relevant MeSH terms:
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Macular Edema
Retinal Diseases
Diabetic Retinopathy
Diabetes Mellitus
Edema
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Macular Degeneration
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications