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Gene Therapy for Diabetic Macular Edema

Sponsor
Frontera Therapeutics (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05916391
Collaborator
Tianjin Medical University Eye Hospital (Other), Peking Union Medical College Hospital (Other), The First Affiliated Hospital of Zhengzhou University (Other)
18
Enrollment
1
Location
3
Arms
59.4
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: FT-003
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
18 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Central Involvement Diabetic Macular EdemaCentral Involvement Diabetic Macular Edema
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Multy-center, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FT-003 in Subjects With Diabetic Macular Edema
Actual Study Start Date :
May 19, 2023
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
May 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: FT003 Dose 1

Low dose of FT-003

Genetic: FT-003
Administration via intraocular injection
Experimental: FT003 Dose 2

Mid dose of FT-003

Genetic: FT-003
Administration via intraocular injection
Experimental: FT003 Dose 3

High dose of FT-003

Genetic: FT-003
Administration via intraocular injection

Outcome Measures

Primary Outcome Measures

  1. Safety and tolerability after FT-003 injection [Whthin 52 weeks after administration]

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

Secondary Outcome Measures

  1. Preliminary effectiveness after FT-003 injection [Whthin 52 weeks after administration]

    Changes in best-corrected visual acuity (BCVA) of the studied eye from baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tianjin Medical University Eye Hospital Tianjin Tianjin,China China 300392

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Frontera Therapeutics
ClinicalTrials.gov Identifier:
NCT05916391
Other Study ID Numbers:
  • FT003DM-1
First Posted:
Jun 23, 2023
Last Update Posted:
Jun 23, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Macular Edema
Edema

Study Results

No Results Posted as of Jun 23, 2023