Gene Therapy for Diabetic Macular Edema

NCT05916391 | Recruiting Phase 1 DMC

• 1 other identifier: FT003DM-1
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability after FT-003 injection

  Incidence and severity of AE (Common Terminology Criteria for Adverse Events 5.0)

  Whthin 52 weeks after administration

Secondary Outcomes (1)

• Preliminary effectiveness after FT-003 injection

  Whthin 52 weeks after administration

Study Arms (3)

FT003 Dose 1

EXPERIMENTAL

Low dose of FT-003

Genetic: FT-003

FT003 Dose 2

EXPERIMENTAL

Mid dose of FT-003

Genetic: FT-003

FT003 Dose 3

EXPERIMENTAL

High dose of FT-003

Genetic: FT-003

Interventions

FT-003 GENETIC

Administration via intraocular injection

FT003 Dose 1; FT003 Dose 2; FT003 Dose 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects that are willing and able to follow study procedures;
• Female or male patients ≥18 years old at the time of signing the ICF;
• Clinically diagnosed with CI-DME
• HbA1c≤10%
• The best corrected visual acuity (BCVA) of the studied eye is ≤ 73 letters

You may not qualify if:

• Presence of any other intraocular diseases other than CI-DME in the studied eye that would affect the improvement of visual acuity and require treatment during the study for prevention or treatment of visual loss, as judged by the investigator

Sponsors & Collaborators

• Frontera Therapeutics: lead
• Tianjin Medical University Eye Hospital: collaborator
• Peking Union Medical College Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator

Study Sites (1)

Tianjin Medical University Eye Hospital

Tianjin, Tianjin,China, 300392, China

RECRUITING

Study Officials

• Xiaorong Li, Professor

  Tianjin Medical University Eye Hospital

  PRINCIPAL INVESTIGATOR

• Hanyi Min, Professor

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

• Guangming Wan, Professor

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinyan Li

CONTACT

+862158206061; Xinyan.li@fronteratherapeutics.com

Minghui Xue

CONTACT

+862158206061; minghui.xue@fronteratherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Central Involvement Diabetic Macular Edema

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: June 23, 2023
• Study Start: May 19, 2023
• Primary Completion: May 1, 2025
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 23, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)