Actively Recruiting
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
Led by Shenzhen MingSight Relin Pharmaceuticals Co., Ltd. · Updated on 2025-09-29
45
Participants Needed
3
Research Sites
8 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
Researchers are evaluating the safety and treatment benefits of MS-553 in patients with diabetic retinopathy who have central involved macular edema. This open-label, phase 1 dose-escalation study focuses on patients who have not previously received treatment for this eye condition. The goal is to observe how different doses of MS-553 affect the condition over an 8-week period. Participants will be divided into three groups, each receiving a different oral dose of MS-553: low, mid, or high. Each dose cohort will include fifteen subjects, and all will take the medication daily for 8 weeks. The study is designed to monitor the effects of these varying doses on the eye condition and any emerging side effects. During the study, participants will undergo regular assessments including measurements of retinal thickness, retinal volume, and visual acuity using standardized eye exams. Researchers will track any treatment-emergent adverse events from the start through day 56. The study lasts approximately 8 weeks, during which safety and treatment effects will be carefully monitored to understand the impact of MS-553 on diabetic macular edema.
CONDITIONS
Brief Title
MS-553 in Diabetic Retinopathy Patients With Central Involved Macular Edema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of type 1 or type 2 diabetes mellitus according to recognized criteria
- Ability to follow study instructions and complete all required visits
- Consent to pregnancy prevention and pregnancy testing if female of childbearing potential
- Presence of central involved macular edema confirmed by optical coherence tomography
- Best corrected visual acuity score of 34 letters or better using ETDRS protocol
- Confirmation that laser photocoagulation and anti-VEGF treatments are declined or not needed for at least 3 months
- Adequate ocular media and pupil dilation to allow quality retinal imaging
You will not qualify if you...
- Unstable metabolic or blood pressure control
- Body mass index below 18.5 or above 28 kg/m2
- Use or need for medications toxic to the eye, such as Deferoxamine, Chloroquine, Tamoxifen, Phenothiazines, or Ethambutol
- History of recent serious cardiac events or stroke within 4 months
- Any condition that may affect safe medication use, study adherence, or study results as judged by an investigator at screening visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 56 days
Participants receive oral doses of MS-553 at varying levels to assess safety and treatment effects on diabetic retinopathy with central involved macular edema.
Multiple visits during the 56-day treatment period
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
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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