Actively Recruiting
MS-553 in Diabetic Retinopathy Patients With Central Involved Macular Edema
Led by Shenzhen MingSight Relin Pharmaceuticals Co., Ltd. · Updated on 2025-09-29
45
Participants Needed
3
Research Sites
343 weeks
Total Duration
On this page
Sponsors
S
Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.
Lead Sponsor
F
Fountain Medical Development Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MS-553 in Diabetic Retinopathy Patients With Central Involved Macular Edema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of diabetes mellitus (type 1 or type 2) according to ADA or WHO diabetic diagnosis criteria
- Ability to follow study instructions and complete all procedures and visits
- Consent to pregnancy prevention and birth control measures if applicable
- Presence of central involved macular edema associated with diabetic retinopathy confirmed by optical coherence tomography at screening
- Best Corrected Visual Acuity score 6 34 letters (approximately 20/200 to 20/20 Snellen equivalent or better) at screening
- Confirmation that laser photocoagulation and anti-VEGF treatments are declined or not needed and can be withheld for at least 3 months after screening
- Adequate ocular media and pupil dilation for good quality retinal imaging at screening
You will not qualify if you...
- Unstable metabolic or blood pressure control
- Body mass index (BMI) less than 18.5 kg/m2 or greater than 28 kg/m2 at screening
- Current use or anticipated need for medications toxic to the lens, retina, or optic nerve such as Deferoxamine, Chloroquine/hydroxychloroquine, Tamoxifen, Phenothiazines, or Ethambutol
- History of myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, acute congestive heart failure treatment, or arrhythmia within 4 months prior to screening
- Any condition that could affect safe medication administration, adherence to visits, safe participation, or study results as judged by the investigator at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Actively Recruiting
2
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
3
Shanghai General Hospital
Shanghai, China, 200080
Actively Recruiting
Research Team
L
Ling Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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