| Trial ID: | L4755 |
| Source ID: | NCT04187443
|
| Associated Drug: |
Ms-553
|
| Title: |
MS-553 in Diabetic Retinopathy Patients With Central Involved Macular Edema
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetic Macular Edema|Macular Edema|Type 2 Diabetes With Diabetic Macular Edema|Type 1 Diabetes With Diabetic Macular Edema|Diabetic Retinopathy
|
| Interventions: |
DRUG: MS-553
|
| Outcome Measures: |
Primary: Treatment-emergent adverse events, Baseline to Day 56 | Secondary: Mean change in the central retina subfield thickness (CRT), Baseline to Day 56|Mean change in the retinal volume, Baseline to Day 56|Proportion of patients with >20% reduction in CRT, Baseline to Day 56|Proportion of patients with resolution of central involved macular edema, Baseline to Day 56|Average mean change in best corrected visual acuity, Baseline to Day 56
|
| Sponsor/Collaborators: |
Sponsor: Shenzhen MingSight Relin Pharmaceuticals Co., Ltd. | Collaborators: Fountain Medical Development Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
45
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2020-06-02
|
| Completion Date: |
2025-07-31
|
| Results First Posted: |
|
| Last Update Posted: |
2025-04-02
|
| Locations: |
The Second Xiangya Hospital of Central South University, Changsha, Hunan, China|West China Hospital of Sichuan University, Chengdu, Sichuan, China|Shanghai General Hospital, Shanghai, 200080, China
|
| URL: |
https://clinicaltrials.gov/show/NCT04187443
|
