Recruiting NCT04187443
MS-553 in Diabetic Retinopathy Patients With Central Involved Macular Edema
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MS-553.
- Who it may be relevant to
- Registry conditions: Diabetic Macular Edema, Macular Edema, Type 2 Diabetes With Diabetic Macular Edema, Type 1 Diabetes With Diabetic Macular Edema. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug MS-553
MS-553
Primary outcome measures
- Treatment-emergent adverse events [Time frame: Baseline to Day 56]
Secondary outcome measures (5)
- Mean change in the central retina subfield thickness (CRT) [Time frame: Baseline to Day 56]
- Mean change in the retinal volume [Time frame: Baseline to Day 56]
- Proportion of patients with >20% reduction in CRT [Time frame: Baseline to Day 56]
- Proportion of patients with resolution of central involved macular edema [Time frame: Baseline to Day 56]
- Average mean change in best corrected visual acuity [Time frame: Baseline to Day 56]
Eligibility criteria
Inclusion criteria
- Diagnosis of diabetes mellitus (type 1 or type 2) according to ADA or WHO diabetic diagnosis criteria
- Subject has the ability to follow the study instructions and is likely to complete all required study procedures and visits;
- All males and females must consent to pregnancy prevention during the study and qualified measures of birth control. All females of childbearing potential must consent to a pregnancy test before entering the study.
- Presence of central involved macular edema associated with diabetic retinopathy, i.e. diabetic macular edema (DME), as assessed by spectral domain optical coherence tomography (sd-OCT) of the central retina subfield thickness (CRT) at the Screening Visit (Centration must be confirmed by Investigators with signatures);
- Best Corrected Visual Acuity (BCVA) score ≥ 34 letters (approximately 20/200 to 20/20 Snellen equivalent or better) using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity protocol, and assessed at the Screening Visit Visual acuity (VA);
- Confirmation by the investigator that laser photocoagulation and anti-VEGF treatments are either declined by the patients or not needed and can be withheld for at least 3 months after the Screening Visit;
- Ocular media and pupil dilation adequate to permit good quality retinal imaging as assessed at Screening Visit.
Exclusion criteria
- Subjects with unstable metabolic or blood pressure control
- Subject with emaciation or obesity at Screening Visit: body mass index (BMI) <18.5kg/m2 or >28kg/m2
- Current use or likely need for medications know to be toxic to the lens, retina or optic nerve, including Deferoxamine, Chloroquine / hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambutol -
- History of myocardial infarction or other cardiac event requiring hospitalization (unstable angina pectoris, etc.), cerebrovascular accident, transient ischemic attack, treatment for acute congestive heart failure or any arrhythmia within 4-months prior to Screening Visit;
- Any situation that may in the opinion of the investigator preclude the safe administration of the study medication, adherence to the scheduled study visits, safe participation in the study or affect the results of the study as assessed at Screening Visit;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 3 centers
- The Second Xiangya Hospital of Central South University — Changsha
- West China Hospital of Sichuan University — Chengdu
- Shanghai General Hospital — Shanghai
Identifiers
NCT: NCT04187443 · 2019-001-CN