A Study of EXG102-031 in Participants With wAMD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-12

Study Completion Date

2025-12-31

Brief Summary

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In neovascular (wet) age-related macular degeneration (wAMD), the macula, or the part of the eye that provides the clear, detailed central vision, is being affected by abnormal blood vessel growth and leakage. This leakage affects the vision over time and can lead to severe blurriness or blinding. EXG102-031 was made to block the extra vessel formation which would lead to less leakage affecting the vision. Before EXG102-031 can be tested for its efficacy (if it makes vision better), it must be tested to see if it is safely tolerated to confirm it can continue to be studied in more patients with wAMD.

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Detailed Description

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Age-related macular degeneration (AMD) is a major cause of blindness and visual impairment in older adults. The wet form of AMD, also called neovascular AMD (nAMD) usually causes faster vision loss than the dry form. The most common current treatments of nAMD are products that inhibit vascular endothelial growth factor (VEGF) (including ranibizumab (LUCENTIS®, Genentech) and aflibercept (EYLEA®, Regeneron) and are delivered by intravitreal injections at 4 to 16 week intervals and continued indefinitely. This Open-label, Dose-escalation Phase I/IIa Study is designed to evaluate the safety and efficacy of EXG102-031 intraocular Injection in participants with wet(Neovascular) Age-related Macular Degeneration（wAMD）.

Conditions

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Neovascular Age-related Macular Degeneration

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Dose escalation

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose escalation-Cohort 1

Genetic : EXG102-031

Group Type EXPERIMENTAL

EXG102-031

Intervention Type BIOLOGICAL

EXG102-031 is a recombinant adeno-associated virus (rAAV) expressing an angiopoietin domain and VEGF receptor (ABD-VEGFR) fusion protein. EXG102-031 will be administered by subretinal injection.

Dose escalation-Cohort 2

Genetic : EXG102-031

Group Type EXPERIMENTAL

EXG102-031

Intervention Type BIOLOGICAL

EXG102-031 is a recombinant adeno-associated virus (rAAV) expressing an angiopoietin domain and VEGF receptor (ABD-VEGFR) fusion protein. EXG102-031 will be administered by subretinal injection.

Dose escalation-Cohort 3

Genetic : EXG102-031

Group Type EXPERIMENTAL

EXG102-031

Intervention Type BIOLOGICAL

EXG102-031 is a recombinant adeno-associated virus (rAAV) expressing an angiopoietin domain and VEGF receptor (ABD-VEGFR) fusion protein. EXG102-031 will be administered by subretinal injection.

Dose escalation-Cohort 4

Genetic : EXG102-031

Group Type EXPERIMENTAL

EXG102-031

Intervention Type BIOLOGICAL

EXG102-031 is a recombinant adeno-associated virus (rAAV) expressing an angiopoietin domain and VEGF receptor (ABD-VEGFR) fusion protein. EXG102-031 will be administered by subretinal injection.

Dose escalation-Cohort 5

Genetic : EXG102-031

Group Type EXPERIMENTAL

EXG102-031

Intervention Type BIOLOGICAL

EXG102-031 is a recombinant adeno-associated virus (rAAV) expressing an angiopoietin domain and VEGF receptor (ABD-VEGFR) fusion protein. EXG102-031 will be administered by subretinal injection.

Interventions

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EXG102-031

EXG102-031 is a recombinant adeno-associated virus (rAAV) expressing an angiopoietin domain and VEGF receptor (ABD-VEGFR) fusion protein. EXG102-031 will be administered by subretinal injection.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Male or female, age ≥ 50 years of age;
2. Diagnosis of wAMD and current active lesion in the study eye at Screening;
3. An ETDRS BCVA letter scores between 73 and 9 letters in the study eye;
4. Response to anti-VEGF treatment within 6 months prior to screening or at the time of screening introduction;
5. The study eye must be a Intraocular lens eye(post-cataract surgery status) and be at least 1 month post IOL implantation at enrollment;
6. Voluntarily agree to participate in the clinical trial, understand the trial procedures, and be capable of signing the informed consent form before screening.

Exclusion Criteria

1. Presence of any ocular disease or history of disease in the study eye other than wAMD that may affect central visual acuity and/or macular detection;
2. Presence in the study eye of CNV or macular pathology pathography due to causes other than wAMD;
3. The study eye has severe and irreversible retinal structural damage involving the fovea (such as retinal pigment epithelial (RPE) atrophy, retinal fibrosis, laser scars, dense hard exudation); Or other retinal damage in the target eye that, in the opinion of the investigator, may impede visual improvement after resolution of macular edema ;
4. Subretinal hemorrhage accumulating the central fovea of the study eye, with an area of hemorrhage ≥ 4 optic disc diameters;
5. Presence of advanced glaucoma or uncontrolled ocular hypertension in the study eye;
6. Prior receipt of any ocular or systemic gene therapy agent.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mingwei Zhao, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

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