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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation-Cohort 1 | Experimental | Genetic : EXG102-031 |
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| Dose escalation-Cohort 2 | Experimental | Genetic : EXG102-031 |
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| Dose escalation-Cohort 3 | Experimental | Genetic : EXG102-031 |
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| Dose escalation-Cohort 4 | Experimental | Genetic : EXG102-031 |
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| Dose escalation-Cohort 5 | Experimental | Genetic : EXG102-031 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXG102-031 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change From Baseline in BCVA (Best Corrected Visual Acuity) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Yang | Contact | +86 13957164092 | sarayang@exegenesisbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Mingwei Zhao, PhD | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100000 | China |
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Dose escalation
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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 |
| 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 |
| 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 |
| Beijing Tongren Hospital,Cmu | Not yet recruiting | Beijing | Beijing Municipality | 100000 | China |
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| Peking University People'S Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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| The Southwest Hospital of Amu | Not yet recruiting | Chongqing | Chongqing Municipality | China |
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| Central theater General Hospital | Recruiting | Wuhai | Hubei | China |
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| Jiangsu Provinve Hospital | Not yet recruiting | Nanjing | Jiangsu | China |
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| The Second Affiliated Hospital Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | China |
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| Eye Hospital,WMU | Not yet recruiting | Wenzhou | Zhejiang | China |
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