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One-and-Done gene shot could spare wet AMD patients from monthly eye needles

NCT ID NCT06196840

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests a gene therapy called LX102 for wet age-related macular degeneration (nAMD), a leading cause of vision loss. The therapy is injected under the retina and aims to produce a protein that blocks abnormal blood vessel growth, potentially reducing the need for frequent anti-VEGF injections. About 50 adults aged 50–89 who have responded well to standard therapy are being studied to see if LX102 is safe and can maintain or improve vision.

What this could mean

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

Active substance
LX102 gene therapy (AAV-based VEGF-trap)
What this could lead to
If it works, this could allow people with wet AMD to need fewer anti-VEGF injections, controlling the disease with a single treatment.
What could go wrong
This is an early phase 2 trial with only 50 participants. Gene therapy carries risks like inflammation or retinal damage, and it may not reduce injection frequency 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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 50 people

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

Started

Jan 2024

Expected to finish

Oct 2029

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 89 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 to sign the informed consent, and willing to attend follow-up visits. 2. Age ≥ 50, and ≤ 89. 3. Diagnosis of active CNV secondary to neovascular AMD. 4. BCVA ETDRS letters between 19 and 73. 5. Demonstrated a meaningful response to anti-VEGF therapy. Exclusion Criteria: 1. CNV or macular edema in the study eye secondary to diseases other than nAMD. 2. Retinal detachment, uveitis, uncontrolled glaucoma in the study eye, or any condition preventing visual acuity improvement. 3. Absence of RPE tear at Screening. 4. Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months. 5. Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg. 6. Uncontrolled diabetes defined as HbA1c \>8.0%.

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Conditions

The condition(s) this trial relates to.

macular degeneration 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

Contacts and locations

Locations

  • Anhui Provincial Hospital

    Hefei, Anhui, China

  • Guangzhou Aier Eye Hospital

    Guangzhou, China

  • Peking Union Medical College Hospital

    Beijing, China

  • Shanghai Eye and ENT Hospital

    Shanghai, China

  • Shanghai General Hospital

    Shanghai, China

  • Shanxi Eye Hospital

    Taiyuan, China

  • Tianjin Medical University Eye Hospital

    Tianjin, China

  • West China Hospital of Sichuan University

    Chengdu, China

  • Xuzhou No.1 People's Hospital

    Xuzhou, China

  • Zhejiang University Eye Hospital

    Hangzhou, Zhejiang, China

  • Zhongshan Ophthalmic Center of Sun Yat-Sen University

    Guangzhou, China

More trials for these conditions

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