Treatment for diabetic retinopathy with MS-553

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label dose-escalation study evaluates the safety and treatment benefits of MS-553 in patients with diabetic retinopathy and central involved macular edema. A total of fifteen subjects will be enrolled in each of three dose cohorts, receiving oral MS-553 for eight weeks. The study aims to assess the drug's effectiveness in improving visual acuity and reducing macular edema in treatment-naive patients. Participants will be monitored for safety and treatment outcomes throughout the study duration.

Why it matters

Who can join: the full rules

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;

Where it's running

• The Second Xiangya Hospital of Central South University
  Changsha, Hunan, China Recruiting
• West China Hospital of Sichuan University
  Chengdu, Sichuan, China Recruiting
• Shanghai General Hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Ling Yang
• Email: yangling@relin.cn
• Phone: +8613421382136

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Corticosteroid for Diabetic Macular Edema (DME) in Adults with Diabetic Retinopathy

  This trial tests whether intravitreal corticosteroid injections can influence inflammatory biomarkers and improve DME in adults with type 2 diabetes.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.