Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

64mo left

Started Aug 2026

Longer than P75 for phase_2

Geographic Reach

1 country

16 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.4 years study duration

Study Progress2%

Aug 2026Jan 2032

First Submitted

Initial submission to the registry

August 12, 2026

Completed

8 days until next milestone

First Posted

Study publicly available on registry

August 20, 2026

Completed

11 days until next milestone

Study Start

First participant enrolled

August 31, 2026

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2027

Expected

4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2032

Last Updated

August 20, 2026

Status Verified

August 1, 2026

Enrollment Period

12 months

First QC Date

August 12, 2026

Last Update Submit

August 17, 2026

Conditions

Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD

Outcome Measures

Primary Outcomes (1)

Change from baseline in best-corrected visual acuity (BCVA)
BCVA measured via the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score
Week 34

Secondary Outcomes (7)

Change from baseline in BCVA
Week 50 and Year 5
Change from baseline in central retinal thickness (CRT)
Week 34, Week 50 and Year 5
Change from baseline in the area of Macular Neovascularization (MNV)
Week 34 and Week 50
Change from baseline in leakage area
Week 34 and Week 50
Annualized mean number of rescue treatments
Week 34, Week 50 and Year 5
+2 more secondary outcomes

Other Outcomes (10)

Neutralizing Antibodies (NAbs) Titer Against the Adeno-Associated Virus Serotype 8(AAV8) Capsid
Week 50
Anti-Drug Antibody (ADA) Titer Against the nVEGF1 Protein
Week 50
T-Cell Immune Response Against the AAV8 Capsid Protein
Week 50
+7 more other outcomes

Study Arms (3)

JWK001 3×10^10 vg/eye group

EXPERIMENTAL

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

JWK001 6×10^10 vg/eye group

EXPERIMENTAL

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

Aflibercept Active Comparator Group

ACTIVE COMPARATOR

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

JWK001DRUG

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

JWK001 3×10^10 vg/eye groupJWK001 6×10^10 vg/eye group

Aflibercept (2.0 mg)DRUG

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.

Aflibercept Active Comparator Group

Eligibility Criteria

Age50 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Written informed consent and ability to comply with the study protocol.
Male or female, aged 50-85 years.
Active subfoveal MNV secondary to nAMD requiring anti-VEGF treatment.
Demonstrated clinical response to aflibercept treatments in the study eye confirmed by the Reading Center;
Study-eye BCVA of 19-78 ETDRS letters.
Pseudophakic study eye.

You may not qualify if:

Any ocular condition other than nAMD that may affect vision, study assessments, treatment safety, or interpretation of results.
Intraocular surgery or intraocular corticosteroid treatment within 4 weeks at screening.
Any ocular condition making the study eye unsuitable for subretinal injection.
Active ocular infection or inflammation, or a history of idiopathic or autoimmune uveitis.
Monocular status or non-study-eye BCVA \<19 ETDRS letters.
Clinically significant systemic disease or infection, malignancy, prohibited concomitant treatment, prior gene therapy, or recent participation in another clinical trial.
Any other condition considered by the investigator to make the subject unsuitable for participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

West China Hospitallead

Study Sites (16)

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

MeSH Terms

Interventions

aflibercept

Central Study Contacts

CONTACT

86-0288542538 lufang@wchscu.cn

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor and Chief Physician

Study Record Dates

First Submitted

August 12, 2026

First Posted

August 20, 2026

Study Start

August 31, 2026

Primary Completion (Estimated)

August 15, 2027

Study Completion (Estimated)

January 14, 2032

Last Updated

August 20, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing: Will not share

Locations

CN(16)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Other Outcomes (10)

Study Arms (3)

JWK001 3×10^10 vg/eye group

JWK001 6×10^10 vg/eye group

Aflibercept Active Comparator Group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (16)

MeSH Terms

Interventions

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations