NCT07750678

Brief Summary

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

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
28mo left

Started Aug 2026

Typical duration for phase_1

Geographic Reach
2 countries

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Aug 2026Dec 2028

Study Start

First participant enrolled

August 1, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 2, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

August 6, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

August 2, 2026

Last Update Submit

August 2, 2026

Conditions

Hereditary Corneal DystrophyCorneal AbnormalityCorneal DystrophiesCorneal Dystrophies, Hereditary

Keywords

Corneal DystrophiesCorneal DystrophyTGFBI Corneal DystrophiesGranular Corneal DystrophyLattice Corneal DystrophyReis-Bücklers Corneal DystrophyThiel-Behnke Corneal DystrophyTGFBI-related corneal dystrophiesGene Therapy

Outcome Measures

Primary Outcomes (3)

  • Incidence of DLTs

    Number and proportion of dose limited toxicity（DLTs）

    30 Days

  • Incidence of AEs

    Number and severity of overall and ocular and systemic adverse events (AEs)

    360 Days

  • Incidence of SAEs

    Number and severity of overall and ocular and systemic serious adverse events (SAEs)

    360 Days

Secondary Outcomes (3)

  • Change in BCVA from baseline over time

    360 Days

  • Change in corneal haze level from baseline over time

    360 Days

  • Time to recurrence of disease

    360 Days

Study Arms (2)

Phase 1

EXPERIMENTAL

GEB-101 dose 1 GEB-101 dose 2 GEB-101 dose 3 GEB-101 dose 4 GEB-101 dose 5

Genetic: GEB-101 Injection

Phase 2

EXPERIMENTAL

GEB-101(RP2D)

Genetic: GEB-101 Injection

Interventions

GEB-101 InjectionGENETIC

Single intrastromal injection

Phase 1Phase 2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females, age 18-70 years (inclusive).
  • TGFBI gene mutation confirmed.
  • Patients with corneal dystrophy who are symptomatic.
  • Willing and able to give signed informed consent and follow study instructions.

You may not qualify if:

  • In either eye: Have any active infection, glaucoma, corneal disease, or other ocular conditions that may affect the assessment of efficacy or safety.
  • In the study eye: Have a history of specific intraocular or corneal surgery, or the presence of active intraocular inflammation or vitreous hemorrhage.
  • Patient with other corneal disorders that may hinder therapeutic surgery or interfere with the interpretation of study results.
  • Prior gene therapy administration in either eye.
  • Active infection occurring or suspected within 4 weeks prior to the investigational product, requiring systemic anti-infective therapy.
  • Subjects with a history of major cardiovascular events within 6 months, the presence of any clinically significant condition, a diagnosis of malignancy within 5 years (with specified exceptions), or active infection with HIV, syphilis, hepatitis C, or hepatitis B.
  • Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period.
  • Disease, condition, or disorder that in the judgement of Investigator could confound study assessments or limit compliance to study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California, Los Angeles (UCLA)

Los Angeles, California, 90095, United States

Location

Fudan University Eye & ENT Hospital

Shanghai, Shanghai Municipality, 200031, China

Location

MeSH Terms

Conditions

Corneal Dystrophies, HereditaryAmyloid Neuropathies, FamilialCorneal dystrophy, Thiel-Behnke type

Condition Hierarchy (Ancestors)

Corneal DiseasesEye DiseasesEye Diseases, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesNervous System DiseasesAmyloid NeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesAmyloidosis, FamilialMetabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic DiseasesAmyloidosisProteostasis Deficiencies

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Phase 1, None (Open Label); Phase 2, double-blind masking.
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Phase 1, single group assignment; Phase 2, parallel assignment
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2026

First Posted

August 6, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

August 6, 2026

Record last verified: 2026-07

Locations

US(1)CN(1)