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Gene Therapy for Diabetic Macular Edema

NCT05916391 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-06-23

No results posted yet for this study

Summary

FT-003 is a gene therapy product developed for the treatment of central involvement diabetic macular edema (CI-DME). Diabetic retinopathy is one of the most common microvascular complications of diabetes mellitus, and diabetic macular edema is the main cause of vision loss in patients with diabetic retinopathy. In the latest guidelines, anti-VEGF therapy is preferred for CI-DME. Administration of FT-003 has the potential to treat CI-DME by providing intraocular protein which is durable expressed in therapeutic level. FT-003 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with CI-DME receiving anti-VEGF therapy in clinical practice.

Conditions

Interventions

GENETIC

FT-003

Administration via intraocular injection

Sponsors & Collaborators

  • Tianjin Medical University Eye Hospital

    collaborator OTHER

  • Peking Union Medical College Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER

  • Frontera Therapeutics

    lead INDUSTRY

Principal Investigators

  • Xiaorong Li, Professor · Tianjin Medical University Eye Hospital

  • Hanyi Min, Professor · Peking Union Medical College Hospital

  • Guangming Wan, Professor · The First Affiliated Hospital of Zhengzhou University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-19
Primary Completion
2025-05-01
Completion
2028-05-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05916391 on ClinicalTrials.gov