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Gene therapy shot could end monthly eye injections for wet AMD

NCT ID NCT07317934

Disease control Sponsor: Innostellar Biotherapeutics Co.,Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 07, 2026 · Updated 3 times

Summary

This Phase 3 trial tests a single injection of LX102 gene therapy under the retina for people with wet age-related macular degeneration (AMD), a leading cause of vision loss. About 332 participants will receive either LX102 or standard aflibercept injections. The goal is to see if LX102 can maintain or improve vision while reducing the need for repeated treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LX102 (a gene therapy given as a single injection under the retina)
What this could lead to
If successful, this could offer a one-time treatment for wet AMD, potentially reducing the need for frequent eye injections.
What could go wrong
This is an early Phase 3 trial, so results are not yet proven. Gene therapy carries risks like inflammation or retinal damage, and it may not work for everyone.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 388 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jun 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 80 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Willing and able to provide written, signed informed consent for this study; 2. Age ≥50 and ≤80 years old; 3. Active CNV secondary to nAMD in the study eye confirmed by FFA or OCT; 4. The BCVA between 24 and 78 letters (inclusive) in the study eye at Screening; 5. Demonstrated clinical response to aflibercept treatments in the study eye confirmed by the Reading Center; 6. No anti-VEGF therapy in study eye within 28 days before screening; 7. Must be pseudophakic in the study eye. Exclusion Criteria: 1. Any condition in the investigator's opinion that could limit VA improvement in the study eye. 2. CNV or macular edema in the study eye secondary to any causes other than AMD 3. Subfoveal atrophy in the study eye, as determined by CRC; 4. History of retinal detachment in the study eye at any time; 5. History of idiopathic or autoimmune uveitis in either eye; 6. Advanced glaucoma in the study eye; 7. History of vitrectomy surgery in the study eye; 8. History of intraocular surgery within 1 month before screening in the study eye; 9. History of ocular or systemic gene therapy; 10. Recent myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months.

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Conditions

The condition(s) this trial relates to.

wet macular degeneration

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neovascular age-related macular degeneration (NAMD) Wet AMD

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    36 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Aier Eye Hospital Group Co., LTD. Changsha Aier Eye Hospital

    RECRUITING

    Changsha, Hunan, 410015, China

  • Beijing Aier-Intech Eye Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100000, China

  • Beijing Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100730, China

  • Central Theater Command General Hospital of PLA

    RECRUITING

    Wuhan, Hubei, 430060, China

  • Eye & ENT Hospital of Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200031, China

  • Hebei Eye Hospital

    RECRUITING

    Xingtai, Hebei, 054000, China

  • Joint Shantou International Eye Center, Shantou University and the Chinese University of Hong Kong

    RECRUITING

    Shantou, Guangdong, 515041, China

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100730, China

  • Qilu Hospital of Shandong University

    RECRUITING

    Jinan, Shandong, 250012, China

  • Qingdao Eye Hospital Affiliated to Shandong First Medical University

    RECRUITING

    Qingdao, Shandong, 266071, China

  • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, 201801, China

  • Shandong Eye Hospital

    RECRUITING

    Jinan, Shandong, 250021, China

  • Shanghai General Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200080, China

  • Shanxi Bethune Hospital

    RECRUITING

    Taiyuan, Shanxi, 030032, China

  • Shanxi Eye Hospital

    RECRUITING

    Taiyuan, Shanxi, 030002, China

  • Shenyang Fourth People's Hospital

    RECRUITING

    Shenyang, Liaoning, 110000, China

  • Sichuan Provincial People's Hospital

    RECRUITING

    Chengdu, Sichuan, 646100, China

  • Southwest Hospital

    RECRUITING

    Chongqing, Chongqing Municipality, 400038, China

  • The Affiliated Eye Hospital of Nanjing Medical University

    RECRUITING

    Nanjing, Jiangsu, 210029, China

  • The Eye Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, 325027, China

  • The First Affiliated Hospital of Air Force Medical University

    RECRUITING

    Xi’an, Shanxi, 710032, China

  • The First Affiliated Hospital of Jinan University

    RECRUITING

    Guangzhou, Guangdong, 510632, China

  • The First Affiliated Hospital of University of Science and Technology of China

    RECRUITING

    Hefei, Anhui, 230601, China

  • The Second Affiliated Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, 400010, China

  • The Second Affiliated Hospital of Harbin Medical University

    RECRUITING

    Harbin, Heilongjiang, 150001, China

  • The Second Hospital of Jilin University

    RECRUITING

    Changchun, Jilin, 130022, China

  • The Second Xiangya Hospital, Central South University

    RECRUITING

    Changsha, Hunan, 410011, China

  • Tianjin Eye Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300020, China

  • Tianjin Medical University Eye Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300384, China

  • Tongji Hospital Tongji Medical College of HUST

    RECRUITING

    Wuhan, Hubei, 430030, China

  • West China Hospital, Sichuan University

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • Xi 'an People's Hospital (Xi 'an No.4 Hospital)

    RECRUITING

    Xi’an, Shanxi, 710004, China

  • Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, 200092, China

  • Xuzhou First People's Hospital

    RECRUITING

    Xuzhou, Jiangsu, 221002, China

  • Zhejiang Provincial People's Hospital

    RECRUITING

    Hangzhou, Zhejiang, 310014, China

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    RECRUITING

    Zhongshan, Guangdong, 510623, China

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