MS-553 in Diabetic Retinopathy Patients With Central Involved Macular Edema

Sponsor
Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.
Study ID
NCT04187443
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MS-553 — DRUG
    MS-553

Study Details

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.

Key Dates

First listed
Dec 5, 2019
Start date
Jun 2, 2020
Status verified
Sep 2025
Primary completion
Oct 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
45 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: MS-553 low dose
    low dose of MS-553 taken orally
  • Experimental: MS-553 mid dose
    mid dose of MS-553 taken orally
  • Experimental: MS-553 high dose
    high dose of MS-553 taken orally

Primary Outcome Measure

Treatment-emergent adverse events [ Time Frame: Baseline to Day 56 ]

Central Contacts

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Diabetic retinopathy trialsOphthalmology trialsRetina trials

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