LX102 gene therapy for neovascular (wet) 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 is a Phase III, randomized, open-label, active-controlled study comparing one subretinal injection of LX102 to standard aflibercept treatment in eyes with active choroidal neovascularization from nAMD. Participants are randomized to receive a single gene-therapy injection versus ongoing aflibercept, with vision measured over time. The primary endpoint is mean change in best-corrected visual acuity (BCVA) from baseline averaged at weeks 40 and 48. Key eligibility includes ages 50–80, prior clinical response to aflibercept, BCVA between 24 and 78 letters, and a pseudophakic study eye.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of University of Science and Technology of China
  Hefei, Anhui, China Recruiting
• Beijing Aier-Intech Eye Hospital
  Beijing, Beijing Municipality, China Recruiting
• Beijing Hospital
  Beijing, Beijing Municipality, China Recruiting
• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting
• The Second Affiliated Hospital of Chongqing Medical University
  Chongqing, Chongqing Municipality, China Recruiting
• Southwest Hospital
  Chongqing, Chongqing Municipality, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ixo-vec gene therapy versus aflibercept for wet age-related macular degeneration (AQUARIUS)

  This study tests whether a single injection of Ixo-vec gene therapy can maintain or improve vision as well as regular aflibercept injections in adults aged 50 and older with active neovascular (wet) AMD.

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• Aflibercept 8 mg in real-world neovascular AMD

  This study tests how well aflibercept 8 mg works in real-world patients with neovascular AMD, including those new to treatment and those who have been treated before.

  Recruiting at 6 sites Peking University People's Hospital · Beijing, Beijing Municipality and 26 other locations · NCT07640997

• Long-term safety test of the Axitinib implant for people with neovascular AMD who finished prior OTX-TKI studies

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  Recruiting at 8 sites Phase 3 Ocular Therapeutix, Inc. · Bakersfield, California and 7 other locations · NCT07516132

• Single intravitreal injection of 4D-150 for macular neovascularization from age-related macular degeneration

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  Recruiting at 11 sites Phase 3 4D Molecular Therapeutics · Scottsdale, Arizona and 125 other locations · NCT07064759

• JWK001 subretinal therapy for neovascular AMD

  This study tests a single subretinal dose of JWK001 at different levels in people with wet age-related macular degeneration who have previously responded to anti-VEGF treatment.

  Recruiting at 2 sites Phase 2 West China Hospital · Beijing, Beijing Municipality and 15 other locations · NCT07776522

• Ixo-vec Contralateral Dosing in Bilateral Wet AMD

  Researchers are testing whether giving Ixo-vec to the second eye of adults with bilateral wet AMD is safe and helps vision over time.

  Recruiting at 12 sites Phase 2 Adverum Biotechnologies, Inc. · Phoenix, Arizona and 11 other locations · NCT07630649

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.