Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 74Years
All Genders
NCT06492876

Gene Therapy for DME

Led by Frontera Therapeutics · Updated on 2024-07-09

78

Participants Needed

1

Research Sites

261 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Gene Therapy for DME

Who Can Participate

Age: 18Years - 74Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing and able to follow study procedures
  • Female or male patients aged 18 to 74 years at time of consent
  • Clinically diagnosed with center-involved Diabetic Macular Edema (CI-DME)
  • Best corrected visual acuity (BCVA) of the studied eye between 24 and 73 letters
Not Eligible

You will not qualify if you...

  • Presence of any other intraocular diseases in the studied eye besides DME that could affect visual improvement or require treatment during the study, as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Tianjin Medical University Eye Hospital

Tianjin, Tianjin,China, China, 300392

Actively Recruiting

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Research Team

X

Xinyan Li

CONTACT

M

Mignhui Xue

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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