NCT04187443 MS-553 in Diabetic Retinopathy Patients With Central Involved Macular Edema
| NCT ID | NCT04187443 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shenzhen MingSight Relin Pharmaceuticals Co., Ltd. |
| Condition | Diabetic Macular Edema |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2020-06-02 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 45 participants in total. It began in 2020-06-02 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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;
Contact & Investigator
Kai Zhang, MD
STUDY DIRECTOR
Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.
Frequently Asked Questions
Who can join the NCT04187443 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetic Macular Edema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04187443 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04187443 currently recruiting?
Yes, NCT04187443 is actively recruiting participants. Contact the research team at yangling@relin.cn for enrollment information.
Where is the NCT04187443 trial being conducted?
This trial is being conducted at Changsha, China, Chengdu, China, Shanghai, China.
Who is sponsoring the NCT04187443 clinical trial?
NCT04187443 is sponsored by Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.. The principal investigator is Kai Zhang, MD at Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.. The trial plans to enroll 45 participants.