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RecruitingNCT07776522Updated Aug 20, 2026

Phase II Study of Subretinal JWK001 for Neovascular Age-Related Macular Degeneration

A Phase 2 interventional study of JWK001 and Aflibercept (2.0 mg) in Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD, sponsored by West China Hospital. Recruiting at 16 sites in China. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by West China Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
All
01

Study summary

This is a Phase II, randomized, open-label, active-controlled study designed to evaluate the preliminary efficacy and safety of a single subretinal administration of JWK001 at different dose levels in patients with neovascular age-related macular degeneration.

02

Conditions studied

  • Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD
03

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    JWK001 3×10^10 vg/eye group

    Participants assigned to this arm will receive a single subretinal injection of JWK001 at a dose of 3 × 10\^10 vector genomes (vg) in one study eye.

    Drug: JWK001

  • Experimental
    JWK001 6×10^10 vg/eye group

    Participants assigned to this arm will receive a single subretinal injection of JWK001 at a dose of 6 × 10\^10 vector genomes (vg) in one study eye.

    Drug: JWK001

  • Active comparator
    Aflibercept Active Comparator Group

    Participants assigned to this arm will receive aflibercept 2 mg by intravitreal injection at Weeks 2, 10, 18, 26, 34, 42, and 50 after randomization.

    Drug: Aflibercept (2.0 mg)

Interventions

  • DrugJWK001

    JWK001 will be administered as a single subretinal injection in one study eye.

  • DrugAflibercept (2.0 mg)

    Aflibercept 2 mg will be administered by intravitreal injection at Weeks 2, 10, 18, 26, 34, 42, and 50 after randomization, for a total of seven injections.

05

What researchers measure

Primary outcomes

  1. Change from baseline in best-corrected visual acuity (BCVA)

    BCVA measured via the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score

    Time frame: Week 34

Secondary outcomes

  1. Change from baseline in BCVA

    BCVA measured via the ETDRS letter score

    Time frame: Week 50 and Year 5

  2. Change from baseline in central retinal thickness (CRT)

    Time frame: Week 34, Week 50 and Year 5

  3. Change from baseline in the area of Macular Neovascularization (MNV)

    MNV measured via Fluorescein Angiography (FFA)

    Time frame: Week 34 and Week 50

  4. Change from baseline in leakage area

    Leakage area assessed by FFA

    Time frame: Week 34 and Week 50

  5. Annualized mean number of rescue treatments

    Time frame: Week 34, Week 50 and Year 5

  6. Change from baseline in the 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) score

    NEI VFQ-25 composite score ranges from 0 to 100. Higher scores indicate better vision-related functioning and quality of life. A positive change from baseline indicates improvement, whereas a negative change indicates worsening.

    Time frame: Week 34 and Week 50

  7. Frequencies and severities of all safety events

    Time frame: Week 34 and Year 5

Other outcomes

  1. Neutralizing Antibodies (NAbs) Titer Against the Adeno-Associated Virus Serotype 8(AAV8) Capsid

    NAbs titer against the AAV8 capsid protein will be assessed in blood samples. Higher titers indicate a stronger neutralizing antibody response.

    Time frame: Week 50

  2. Anti-Drug Antibody (ADA) Titer Against the nVEGF1 Protein

    ADA titers against the nVEGF1 protein expressed by JWK001 will be measured in blood samples. Higher titers indicate a stronger anti-drug antibody response.

    Time frame: Week 50

  3. T-Cell Immune Response Against the AAV8 Capsid Protein

    T-cell immune responses against the AAV8 capsid protein will be assessed using an enzyme-linked immunospot (ELISpot) assay.

    Time frame: Week 50

  4. T-Cell Immune Response Against the nVEGF1 Protein

    T-cell immune responses against the nVEGF1 protein will be assessed using an enzyme-linked immunospot (ELISpot) assay.

    Time frame: Week 50

  5. JWK001 Vector DNA Level in Blood

    JWK001 vector DNA will be measured in blood samples.

    Time frame: Week 4

  6. JWK001 Vector DNA Level in Tears

    JWK001 vector DNA will be measured in tear samples

    Time frame: Week 4

  7. JWK001 Vector DNA Level in Urine

    JWK001 vector DNA will be measured in urine samples

    Time frame: Week 4

  8. JWK001 Vector DNA Level in Feces

    JWK001 vector DNA will be measured in fecal samples

    Time frame: Week 4

  9. Concentration of the nVEGFi Transgene Expression Product in Blood

    The concentration of the nVEGFi transgene expression product will be measured in blood samples

    Time frame: Week 50

  10. Concentration of the nVEGFi Transgene Expression Product in Aqueous Humor

    The concentration of the nVEGFi transgene expression product will be measured in aqueous humor samples

    Time frame: Week 104

06

Study locations

2 of 16 sites recruiting
  • Beijing Hospital
    Beijing, Beijing Municipality 100000, China
    Recruiting
  • Peking University People's Hospital
    Beijing, Beijing Municipality 100000, China
    Not yet recruiting
  • The Second Hospital of Jilin University
    Jilin City, Changchun 130000, China
    Not yet recruiting
  • Southwest Hospital, Army Medical University（Southwest Hospital）
    Chongqing, Chongqing Municipality 400000, China
    Not yet recruiting
  • Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong
    Shantou, Guangdong 515000, China
    Not yet recruiting
  • Zhejiang Provincial People's Hospital
    Zhejiang, Hangzhou 310000, China
    Not yet recruiting
  • The Second Affiliated Hospital of Harbin Medical University
    Harbin, Heilongjiang 150000, China
    Not yet recruiting
  • Henan Provincial People's Hospital
    Zhengzhou, Henan 450000, China
    Not yet recruiting
  • General Hospital of Central Theater Command, Chinese People's Liberation Army
    Wuhan, Hubei 430000, China
    Not yet recruiting
  • Jiangsu Provincial People's Hospital, The First Affiliated Hospital of Nanjing Medical University
    Nanjing, Jiangsu 210000, China
    Not yet recruiting
  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
    Shanghai, Shanghai Municipality 200000, China
    Not yet recruiting
  • Shanxi Bethune Hospital
    Taiyuan, Shanxi '030000, China
    Not yet recruiting
  • Shanxi Eye Hospital
    Taiyuan, Shanxi 030000, China
    Not yet recruiting
  • West China Hospital, Sichuan University
    Chengdu, Sichuan 610000, China
    Recruiting
  • Tianjin Eye Hospital
    Tianjin, Tianjin Municipality 300000, China
    Not yet recruiting
  • The First People's Hospital of Yunnan Province
    Kunming, Yunnan 650000, China
    Not yet recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07776522
Lead sponsor
West China Hospital
Responsible party
Fang Lu (Professor and Chief Physician, West China Hospital) — Principal investigator
First posted
Aug 20, 2026
Start date
Aug 31, 2026 (estimated)
Primary completion
Aug 15, 2027 (estimated)
Completion
Jan 14, 2032 (estimated)
Last update
Aug 20, 2026

Study contacts

Lu
Contact
lufang@wchscu.cn
86-0288542538

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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