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Gene Therapy for Diabetic Macular Edema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05916391
Recruitment Status : Recruiting
First Posted : June 23, 2023
Last Update Posted : June 23, 2023
Sponsor:
Collaborators:
Tianjin Medical University Eye Hospital
Peking Union Medical College Hospital
The First Affiliated Hospital of Zhengzhou University
Information provided by (Responsible Party):
Frontera Therapeutics

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
Diabetic Macular Edema Genetic: FT-003 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Central 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
Estimated Primary Completion Date : May 1, 2025
Estimated Study Completion Date : May 1, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

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




Primary Outcome Measures :
  1. Safety and tolerability after FT-003 injection [ Time Frame: 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 [ Time Frame: Whthin 52 weeks after administration ]
    Changes in best-corrected visual acuity (BCVA) of the studied eye from baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05916391


Contacts
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Contact: Xinyan Li +862158206061 Xinyan.li@fronteratherapeutics.com
Contact: Minghui Xue +862158206061 minghui.xue@fronteratherapeutics.com

Locations
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China, Tianjin,China
Tianjin Medical University Eye Hospital Recruiting
Tianjin, Tianjin,China, China, 300392
Contact: Xiaorong Li, Professor         
Sponsors and Collaborators
Frontera Therapeutics
Tianjin Medical University Eye Hospital
Peking Union Medical College Hospital
The First Affiliated Hospital of Zhengzhou University
Investigators
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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
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Responsible Party: Frontera Therapeutics
ClinicalTrials.gov Identifier: NCT05916391    
Other Study ID Numbers: FT003DM-1
First Posted: June 23, 2023    Key Record Dates
Last Update Posted: June 23, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases