RecruitingPhase 1NCT04187443

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

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


Sponsor

Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.

Enrollment

45 participants

Start Date

Jun 2, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new eye drop medication called MS-553 in people with diabetic retinopathy who also have macular edema (swelling in the central part of the retina that affects vision) — a complication of diabetes that can lead to vision loss. **You may be eligible if...** - You have a confirmed diagnosis of diabetes (type 1 or type 2) - You have diabetic retinopathy with central macular edema in at least one eye - You are able to follow study instructions and attend all required visits - You are willing to use effective birth control during the study **You may NOT be eligible if...** - You have recently had eye surgery or laser treatment in the affected eye - You are pregnant or breastfeeding - You have another serious eye condition in the affected eye (such as glaucoma or severe cataracts) - You are taking medications that may interact with the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMS-553

MS-553


Locations(3)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Shanghai General Hospital

Shanghai, China

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NCT04187443


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