A Study of EXG102-031 in Participants With wAMD
An Open-label, Dose-escalation Phase I/IIa Study to Evaluate the Safety and Efficacy of EXG102-031 Intraocular Injection in Participants With Neovascular Age-related Macular Degeneration（wAMD）
1 other identifier
interventional
42
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2023
Typical duration for phase_1
8 active sites
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 Start
First participant enrolled
October 12, 2023
CompletedFirst Submitted
Initial submission to the registry
December 4, 2023
CompletedFirst Posted
Study publicly available on registry
December 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJanuary 9, 2024
January 1, 2024
2.2 years
December 4, 2023
January 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety (Participants With Ocular and Non-ocular AEs (Adverse Events) and SAEs (Serious Adverse Events)
incidence of ocular and non-ocular AEs and SAEs
24 weeks following EXG102-031 administration
Secondary Outcomes (4)
Safety (Participants With Ocular and Non-ocular AEs (Adverse Events) and SAEs (Serious Adverse Events)
52 weeks following EXG102-031 administration
Change From Baseline in BCVA (Best Corrected Visual Acuity)
52 weeks following EXG102-031 administration
Change From Baseline in CRT (Central Retinal Thickness)
52 weeks following EXG102-031 administration
Supplemental Injections (Annualized Rate of Supplemental Injections)
52 weeks following EXG102-031 administration
Study Arms (5)
Dose escalation-Cohort 1
EXPERIMENTALGenetic : EXG102-031
Dose escalation-Cohort 2
EXPERIMENTALGenetic : EXG102-031
Dose escalation-Cohort 3
EXPERIMENTALGenetic : EXG102-031
Dose escalation-Cohort 4
EXPERIMENTALGenetic : EXG102-031
Dose escalation-Cohort 5
EXPERIMENTALGenetic : EXG102-031
Interventions
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.
Eligibility Criteria
You may qualify if:
- Male or female, age ≥ 50 years of age;
- Diagnosis of wAMD and current active lesion in the study eye at Screening;
- An ETDRS BCVA letter scores between 73 and 9 letters in the study eye;
- Response to anti-VEGF treatment within 6 months prior to screening or at the time of screening introduction;
- The study eye must be a Intraocular lens eye(post-cataract surgery status) and be at least 1 month post IOL implantation at enrollment;
- Voluntarily agree to participate in the clinical trial, understand the trial procedures, and be capable of signing the informed consent form before screening.
You may not qualify if:
- 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;
- Presence in the study eye of CNV or macular pathology pathography due to causes other than wAMD;
- 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 ;
- Subretinal hemorrhage accumulating the central fovea of the study eye, with an area of hemorrhage ≥ 4 optic disc diameters;
- Presence of advanced glaucoma or uncontrolled ocular hypertension in the study eye;
- Prior receipt of any ocular or systemic gene therapy agent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Beijing Hospital
Beijing, Beijing Municipality, 100000, China
Beijing Tongren Hospital,Cmu
Beijing, Beijing Municipality, 100000, China
Peking University People'S Hospital
Beijing, Beijing Municipality, 100000, China
The Southwest Hospital of Amu
Chongqing, Chongqing Municipality, China
Central theater General Hospital
Wuhai, Hubei, China
Jiangsu Provinve Hospital
Nanjing, Jiangsu, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Eye Hospital,WMU
Wenzhou, Zhejiang, China
Study Officials
- PRINCIPAL INVESTIGATOR
Mingwei Zhao, PhD
Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2023
First Posted
December 28, 2023
Study Start
October 12, 2023
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
January 9, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share