Can a single gene injection replace monthly eye shots for wet AMD?
NCT ID NCT07776522
First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This phase II trial is testing whether a single subretinal injection of JWK001, a gene therapy, can safely and effectively treat wet age-related macular degeneration (nAMD). The study includes about 50 adults aged 50-85 with active disease who have responded to prior aflibercept treatment. Participants receive either JWK001 at different doses or standard aflibercept injections, and researchers will compare changes in vision and retinal structure over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- JWK001, a gene therapy given as a single subretinal injection, compared with aflibercept eye injections
- What this could lead to
- If successful, this could lead to a one-time treatment for wet AMD that reduces or eliminates the need for repeated eye injections, preserving vision longer.
- What could go wrong
- This is an early-phase trial with a small number of participants. The gene therapy may not provide lasting benefit, and subretinal injection carries risks like bleeding, infection, or retinal damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Written informed consent and ability to comply with the study protocol. 2. Male or female, aged 50-85 years. 3. Active subfoveal MNV secondary to nAMD requiring anti-VEGF treatment. 4. Demonstrated clinical response to aflibercept treatments in the study eye confirmed by the Reading Center; 5. Study-eye BCVA of 19-78 ETDRS letters. 6. Pseudophakic study eye. Exclusion Criteria: 1. Any ocular condition other than nAMD that may affect vision, study assessments, treatment safety, or interpretation of results. 2. Intraocular surgery or intraocular corticosteroid treatment within 4 weeks at screening. 3. Any ocular condition making the study eye unsuitable for subretinal injection. 4. Active ocular infection or inflammation, or a history of idiopathic or autoimmune uveitis. 5. Monocular status or non-study-eye BCVA \<19 ETDRS letters. 6. Clinically significant systemic disease or infection, malignancy, prohibited concomitant treatment, prior gene therapy, or recent participation in another clinical trial. 7. Any other condition considered by the investigator to make the subject unsuitable for participation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
16 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Hospital
RECRUITINGBeijing, Beijing Municipality, 100000, China
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General Hospital of Central Theater Command, Chinese People's Liberation Army
NOT_YET_RECRUITINGWuhan, Hubei, 430000, China
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Henan Provincial People's Hospital
NOT_YET_RECRUITINGZhengzhou, Henan, 450000, China
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Jiangsu Provincial People's Hospital, The First Affiliated Hospital of Nanjing Medical University
NOT_YET_RECRUITINGNanjing, Jiangsu, 210000, China
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Peking University People's Hospital
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 100000, China
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Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
NOT_YET_RECRUITINGShanghai, Shanghai Municipality, 200000, China
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Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong
NOT_YET_RECRUITINGShantou, Guangdong, 515000, China
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Shanxi Bethune Hospital
NOT_YET_RECRUITINGTaiyuan, Shanxi, '030000, China
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Shanxi Eye Hospital
NOT_YET_RECRUITINGTaiyuan, Shanxi, 030000, China
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Southwest Hospital, Army Medical University（Southwest Hospital）
NOT_YET_RECRUITINGChongqing, Chongqing Municipality, 400000, China
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The First People's Hospital of Yunnan Province
NOT_YET_RECRUITINGKunming, Yunnan, 650000, China
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The Second Affiliated Hospital of Harbin Medical University
NOT_YET_RECRUITINGHarbin, Heilongjiang, 150000, China
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The Second Hospital of Jilin University
NOT_YET_RECRUITINGJilin City, Changchun, 130000, China
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Tianjin Eye Hospital
NOT_YET_RECRUITINGTianjin, Tianjin Municipality, 300000, China
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West China Hospital, Sichuan University
RECRUITINGChengdu, Sichuan, 610000, China
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Zhejiang Provincial People's Hospital
NOT_YET_RECRUITINGZhejiang, Hangzhou, 310000, China
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