A Study of EXG102-031 in Participants With wAMD

Neovascular Age-related Macular Degeneration Clinical Trial

Official title:

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）

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06183814
• Other study ID #: EXG102-031-111
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 12, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Hangzhou Jiayin Biotech Ltd
• Contact: Sara Yang
• Phone: +86 13957164092
• Email: sarayang[@]exegenesisbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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）.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
China	The Southwest Hospital of Amu	Chongqing	Chongqing
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Jiangsu Provinve Hospital	Nanjing	Jiangsu
China	Beijing Hospital	Peking	Beijing
China	Beijing Tongren Hospital,Cmu	Peking	Beijing
China	Peking University People'S Hospital	Peking	Beijing
China	Eye Hospital,WMU	Wenzhou	Zhejiang
China	Central theater General Hospital	Wuhai	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Jiayin Biotech Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety (Participants With Ocular and Non-ocular AEs (Adverse Events) and SAEs (Serious Adverse Events)	incidence of ocular and non-ocular AEs and SAEs	52 weeks following EXG102-031 administration
Secondary	Change From Baseline in BCVA (Best Corrected Visual Acuity)	Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision.	52 weeks following EXG102-031 administration
Secondary	Change From Baseline in CRT (Central Retinal Thickness)	Retinal fluid status of the study eye was evaluated using spectral domain OCT (Optical Coherence Tomography). A decrease in value indicates a decrease in fluid	52 weeks following EXG102-031 administration
Secondary	Supplemental Injections (Annualized Rate of Supplemental Injections)	The number of supplemental anti-VEGF injections given after EXG102-031 was administered.	52 weeks following EXG102-031 administration