Treatment for diabetic retinopathy with MS-553
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
This study is testing a new oral medication called MS-553 to see if it can improve vision and reduce swelling in the eyes of people with diabetic retinopathy.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | MingSight Pharmaceuticals, Inc Industry-sponsored |
| Locations | 3 sites (Changsha, Hunan and 2 other locations) |
| Trial ID | NCT04187443 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with type 1 or type 2 diabetes who have central involved macular edema associated with diabetic retinopathy.
Not a fit: Patients with advanced diabetic retinopathy or those who have previously received treatment for diabetic macular edema may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve vision and reduce complications in patients suffering from diabetic macular edema.
How similar studies have performed: Other studies have shown promise in treating diabetic macular edema with novel therapies, but this specific approach with MS-553 is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
Changsha, Hunan and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.