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The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of intravitreal injection of EXG202 in subjects with neovascular age-related Macular Degeneration (nAMD).
EXG 202 is a gene therapy product developed for the treatment of neovascular age-related macular degeneration (nAMD). Neovascular AMD is the main cause of blindness among elderly individuals. The available therapies for treating nAMD require life-long intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. Administration of EXG202 has the potential to treat nAMD by providing durable expression of therapeutic levels of intraocular protein and maintaining the vision of patients. EXG 202 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Dose escalation-Cohort A | Experimental | Dose 1 :Administered via intravitreal injection |
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| Experimental: Dose escalation-Cohort B | Experimental | Dose 2 :Administered via intravitreal injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXG202 | Biological | EXG202 is a gene therapy product for the treatment of wet (neovascular) age-related macular degeneration(wAMD) with a single intravitreal injection and administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability after EXG202 injection | Frequency, type, and intensity of ocular and non-ocular Adverse Events (AEs) and serious adverse events (SAE) at Week 52, to explore the maximum tolerated dose (MTD) | up to 52 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy after EXG202 injection | the Best Corrected Visual Acuity (BCVA) change from baseline | up to 52 weeks after treatment |
| To evaluate the efficacy after EXG202 injection | The optical coherence tomography (OCT ). |
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Inclusion Criteria:
Male or female, aged ≥50 years old;
The study eye must meet the following criteria:
A. Diagnosed of wAMD and current active lesions; active, defined as the presence of any of the following lesions in the macular area upon OCT examination: a) intraretinal hemorrhage or fluid; b) subretinal fluid; c) subretinal hemorrhage; B. The BCVA score tested during screening using the ETDRS eye chart (see Appendix 3 for details) must be between 73-19 letters (including boundary values), (equivalent to Snellen visual acuity of 20/40 to 20/400);
Clinically meaningful response to standard anti-VEGF therapy within 6 months before screening or during the lead-in period of screening.
The subject has clear refractive media and sufficient pupil dilation at the time of screening to obtain high-quality retinal images for confirmation of diagnosis;
Subjects (including male subjects) have no pregnancy plans during the screening period and the entire trial period and voluntarily take effective contraceptive measures and have no sperm or egg donation plans;
Voluntarily participate in this clinical trial, understand the research procedures and sign the informed consent form before screening; have good compliance and are willing to abide by the research procedures.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Yang | Contact | 13957164092 | sarayang@exegenesisbio.com | |
| Lifei Wang, Ph.D | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei Eye Hospital | Xingtai | Hebei | 054001 | China |
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Dose escalation
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| 52 weeks following EXG202 treatment. |
| The Fourth Affiliated Hospital of Zhejiang University School of Medicine | Yiwu | Zhejiang | 322000 | China |
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