JWK001 subretinal therapy for neovascular AMD

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 II, randomized, open-label, active-controlled trial designed to evaluate the preliminary efficacy and safety of a one-time subretinal administration of JWK001 at several dose levels in patients with neovascular AMD. Patients will be assigned to receive JWK001 or aflibercept as a control, with the study eye required to have active subfoveal neovascularization and prior responsiveness to anti-VEGF therapy. Key eligibility includes age 50-85, certain visual acuity ranges, and pseudophakic status, while exclusions cover other ocular diseases, recent intraocular treatments, and systemic conditions that could affect outcomes. The trial is conducted across multiple Beijing-area and Jilin University-affiliated centers, led by West China Hospital.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Hospital
  Beijing, Beijing Municipality, China Recruiting
• West China Hospital, Sichuan University
  Chengdu, Sichuan, China Recruiting
• Peking University People's Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• The Second Hospital of Jilin University
  Jilin City, Changchun, China Not yet recruiting
• Southwest Hospital, Army Medical University（Southwest Hospital）
  Chongqing, Chongqing Municipality, China Not yet recruiting
• Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong
  Shantou, Guangdong, China Not yet recruiting

Study contacts

• Study coordinator: Lu
• Email: lufang@wchscu.cn
• Phone: 86-0288542538

Similar studies

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

• 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

• Neoadjuvant Cryo-Thermal Ablation with Toripalimab and Chemo for Resectable NSCLC

  This study tests whether using Cryo-Thermal Ablation before chemo-immunotherapy helps people with resectable NSCLC see better outcomes.

  Recruiting Phase 2 West China Hospital · Chengdu, Sichuan and 8 other locations · NCT07855965

• Tai Chi during radiotherapy for head and neck cancer fatigue

  This trial tests whether a 12-week Yang-style Tai Chi program added to usual care can reduce cancer-related fatigue in adults with head and neck cancer undergoing radiotherapy.

  Recruiting West China Hospital · Chengdu, Sichuan · NCT07809776

• Wireless home prehabilitation for older adults with NSCLC awaiting lung surgery

  This study tests whether a personalized home exercise program guided by wearable devices can improve lung function for older NSCLC patients preparing for curative lung surgery.

  Recruiting West China Hospital · Chengdu, Sichuan · NCT07809763

• First-line combo therapy with GnP, SHR-1701, and Apatinib for metastatic pancreatic cancer

  This trial tests whether adding SHR-1701 and Apatinib to standard GnP can safely and effectively treat previously untreated metastatic pancreatic cancer.

  Recruiting Phase 1/2 West China Hospital · Chengdu, Sichuan · NCT07802184

• Early warning and stratified diagnosis of postoperative respiratory failure using ventilator waveform features

  This study tests whether patterns in ventilator waveforms can predict and categorize risk of breathing failure after surgery for adults on mechanical ventilation.

  Recruiting West China Hospital · Chengdu, Sichuan · NCT07799636

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.