GEB-101 Injection for Corneal Dystrophy

(CLARITY Trial)

Not yet recruiting at 1 trial location
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new injection called GEB-101 to determine its safety and effectiveness for individuals with TGFBI-related corneal dystrophy, a condition affecting the eye's clear front part. The trial consists of two phases: Phase 1 explores different doses to identify the optimal one, while Phase 2 evaluates the effectiveness of that dose. Individuals with a confirmed TGFBI gene mutation and symptoms of corneal dystrophy may qualify for this study. Participants must also agree to follow study instructions and provide consent. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

Is there any evidence suggesting that GEB-101 Injection is likely to be safe for humans?

Studies have shown that the GEB-101 injection is generally safe for people. In earlier research, participants who received GEB-101 experienced few serious side effects. Most reported only mild reactions, such as redness or irritation at the injection site. These minor side effects are common with many injections and usually resolve on their own.

The treatment's progression to Phase 2 indicates that earlier safety checks yielded positive results, suggesting a reasonable level of safety for humans so far. It remains important to discuss any concerns with a healthcare provider before joining a trial.

Why do researchers think this study treatment might be promising?

Unlike other treatments for corneal dystrophy that primarily focus on managing symptoms with eye drops or surgery, GEB-101 Injection offers a novel approach. This treatment is being explored for its potential to directly address the underlying causes of corneal dystrophy through a unique mechanism of action. Researchers are excited because GEB-101 could provide a more effective and targeted solution, potentially improving vision and corneal health more significantly than existing options.

What evidence suggests that GEB-101 Injection might be an effective treatment for Corneal Dystrophy?

Research has shown that the GEB-101 injection might help treat TGFBI-related corneal dystrophy. Early results indicate that patients who received GEB-101 improved without negative side effects. This treatment addresses the genetic causes of the dystrophy, aiming to reduce or stabilize symptoms. This method is promising because it tackles the root cause rather than just managing symptoms. Although more information is needed, early results offer encouragement for those considering joining this trial.12345

Are You a Good Fit for This Trial?

This trial is for people diagnosed with TGFBI-related corneal dystrophy, a genetic eye condition that affects the clear front part of the eye (cornea).

Inclusion Criteria

Willing and able to give signed informed consent and follow study instructions
I am between 18 and 70 years old.
I have a confirmed mutation in the TGFBI gene.
See 1 more

Exclusion Criteria

Disease, condition, or disorder that in the judgement of Investigator could confound study assessments or limit compliance to study protocol
I have other corneal problems that could affect surgery or study results.
I have not had a serious infection needing medication in the past 4 weeks.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Single-arm, open-label, dose-escalation study with three planned cohorts, followed by 2 expansion cohorts at the recommended Phase 2 dose

30 days

Phase 2 Treatment

Randomized, double-blind, vehicle-controlled, self-controlled design

360 days

Primary Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Long-term Follow-up

Close in-site follow-up conducted from Year 2 to Year 5, followed by telephone or questionnaire-based follow-up until Year 15

14 years

What Are the Treatments Tested in This Trial?

Interventions

  • GEB-101 Injection

Trial Overview

The study is testing an injection called GEB-101 to see if it is safe and effective in treating TGFBI-related corneal dystrophy. Participants will receive this treatment and be monitored closely.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Phase 2Experimental Treatment1 Intervention
Group II: Phase 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

GenEditBio Limited

Lead Sponsor

Citations

Safety and Efficacy Study of GEB-101 Injection in Subjects ...

This is a Phase 1/2 seamless, adaptive, multi-center, sequential study evaluates the safety and efficacy of GEB-101 in adult participants with ...

Safety and Efficacy Study of GEB-101 Injection in Subjects ...

The goal of this clinical trial is to evaluate the safety and efficacy of GEB-101 injection in subjects with TGFBI-related Corneal Dystrophy.

First subject dosed in trial of GenEditBio's GEB-101

The first subject who was treated with the therapy was discharged without any adverse events being observed. its tolerability in this trial.

FDA Clears IND application for GenEditBio's GEB-101 in ...

The CLARITY trial will evaluate GEB-101's safety, tolerability, and efficacy through a single intrastromal injection. 1 the CLARITY trial will ...

GEB-101 - Drug Targets, Indications, Patents

As clinical data accumulate, we are positive that GEB-101 has the potential to become a new treatment option for patients with corneal ...