Gene Therapy for DME

Phase 2RecruitingNCT06492876

Frontera Therapeutics78 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Macular Edema

Interventions

FT-003GENETIC

Administered via intraocular injection.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 74 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tianjin Medical University Eye Hospital

Tianjin, Tianjin,China, China

RECRUITING

Outcomes

Primary Outcomes

Safety and tolerability after FT-003 injection

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

Time frame: At Week 12

Secondary Outcomes

To evaluate the efficacy after FT-003 injection

the BCVA /CST change from baseline

Time frame: At Week 24

Central Contacts

Xinyan Li

CONTACT

+86-021-58206061 Xinyan.li@fronteratherapeutics.com

Mignhui Xue

CONTACT

+86-021-58206061 minghui.xue@fronteratherapeutics.com

Data from ClinicalTrials.gov

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