Gene Therapy for DME | NCT06492876

Studies
Gene Therapy for DME

NCT06492876

Sponsor

Frontera Therapeutics

Status

Recruiting

Last Update Posted

Jul 9, 2024Actual

Enrollment

78Estimated

Phase

Phase 1Phase 2

Conditions

Diabetic Macular Edema

Interventions

FT-003

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2023Actual

Primary Completion Date

Nov 15, 2024Estimated

Completion Date

Nov 15, 2028Estimated

First Submitted Date

Jul 1, 2024

First Submission Date that Met QC Criteria

Jul 1, 2024

First Posted Date

Jul 9, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2024

Last Update Posted Date

Jul 9, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of disposable vitreous injection of FT-003 in subjects with Diabetic Macular Edema (DME). The study was divided into two phases, Phase 1 dose escalation and Phase II dose expansion.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

78Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
FT-003	Genetic	Administered via intraocular injection.	FT003 Dose 1 FT003 Dose 2 FT003 Dose 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability after FT-003 injection	Incidence and severity of AE (Common Terminology Criteria for Adverse Events 5.0)	At Week 12

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the efficacy after FT-003 injection	the BCVA /CST change from baseline	At Week 24

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects that are willing and able to follow study procedures;
Female or male patients 18-74 years old at the time of signing the ICF;
Clinically diagnosed with CI-DME;
The best corrected visual acuity (BCVA) of the studied eye is 24-73 letters;

Exclusion Criteria:

Presence of any other intraocular diseases other than 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xinyan Li	Contact	+86-021-58206061		Xinyan.li@fronteratherapeutics.com
Mignhui Xue	Contact	+86-021-58206061		minghui.xue@fronteratherapeutics.com

Overall Officials

Name	Affiliation	Role
Xiaorong Li, Professor	Tianjin Medical University Eye Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tianjin Medical University Eye Hospital	Recruiting	Tianjin	Tianjin,China	300392	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided