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

Launched by SHENZHEN MINGSIGHT RELIN PHARMACEUTICALS CO., LTD. · Dec 3, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at a new medication called MS-553 to see how safe it is and if it can help patients with diabetic retinopathy who have central involved macular edema, a condition that can affect vision. The study will involve 15 patients at a time, and they will take MS-553 by mouth for eight weeks. The goal is to find out if this treatment can improve their eye health without causing significant side effects.

To participate, you need to have diabetes (either type 1 or type 2) and be diagnosed with diabetic macular edema. You also need to be able to follow the study instructions and complete visits, and if you are a woman who can become pregnant, you'll need to agree to take measures to prevent pregnancy. During the trial, you'll be monitored closely to ensure the medication is safe for you. If you have certain health conditions or are taking specific medications, you may not be eligible. Overall, this study aims to provide more options for managing eye problems related to diabetes.

Gender

ALL

Eligibility 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;