Gene-editing therapy for treating neovascular age-related macular degeneration

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of CRISPR/Cas13-mediated RNA targeting therapy, specifically HG202, to treat neovascular age-related macular degeneration (nAMD), a condition that leads to severe vision loss. The trial aims to address the limitations of current anti-VEGF therapies, which often require frequent injections and may lead to complications or reduced efficacy over time. Participants will be evaluated based on their visual acuity and responsiveness to previous anti-VEGF treatments. The goal is to provide a more effective and long-lasting treatment option for patients suffering from nAMD.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Males or females ≥ 50 and ≤ 80 years at the time of signing the ICF
* Diagnosed of choroidal neovascularization (CNV) secondary to AMD in the study eye;
* Best-corrected visual acuity (BCVA) ranged from 73 to 23 early treatment diabetic retinopathy study (ETDRS)letter score (corresponding to 20/32 to 20/320 of Snellen visual acuity) in the study eye;
* BCVA in the non-study eye had an ETDRS letter score of 19(equivalent to Snellen visual acuity20/400) and above;
* Able to perform visual acuity and retinal function tests and able and willing to comply with study procedures for this clinical trial;

RESPONSIVE SUBJECTS:

* History of need for and responsive to anti-VEGF therapy in the study eye

NON-RESPONSIVE SUBJECTS:

* History of receiving anti-VEGF therapy but is resistant to treatment, which is defined as: a. complete or near-complete remission of subretinal fluid after the initial 3 doses of anti-VEGF agents and thenno improvement (less than 50um reduction) or deterioration of CRT by OCT

Exclusion Criteria:

* Subretinal hemorrhage, scarring, or fibrosis of greater than 50% of the total lesion in the study eye;
* Any condition in the Investigator's opinion that could limit visual improvement in the study eye;
* Other ocular diseases that may affect central vision in the study eye (e.g., retinal vein occlusion, retinal detachment, macular hole, optic nerve disease, etc.);
* Presence of CNV not due to nAMD in the study eye,
* Uncontrolled glaucoma in the study eye;
* Active intraocular inflammation or a history of uveitis in either eye;
* History or presence of corneal dystrophy in the study eye;
* Subjects with immunodeficiency diseases prone to opportunistic infections;
* History of other intraocular surgery in the study eye within 3 months prior to baseline that in the Investigator's opinion could impact healing or study outcome interpretation;
* Prior gene therapy or oligonucleotide therapy;
* History of acute coronary syndrome, myocardial infarction, coronary revascularization, cerebrovascular accident, or transient ischemic attack within 6 months prior to the Screening Visit;
* Other conditions judged by the investigator as inappropriate for the study.

Where it's running

• Eye & ENT Hospital of Fudan University
  Shanghai, Shanghai Municipality, China Recruiting
• Tianjin Medical University Eye Hospital
  Tianjin, Tianjing, China Recruiting

Study contacts

• Study coordinator: Study Director
• Email: HG20201@huidagene.com
• Phone: +86 021-25076143

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• JWK001 subretinal therapy for neovascular AMD

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.