Neovascular Age-Related Macular Degeneration (nAMD) Wet AMDPhase 2NCT07776522
Phase II Study of Subretinal JWK001 for Neovascular Age-Related Macular Degeneration
A Phase 2 study testing JWK001 and Aflibercept (2.0 mg) in people with Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD, run by West China Hospital at 16 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD
- What is being tested?
- JWK001 and Aflibercept (2.0 mg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 16 sitesChina
- Study dates
- 31 Aug 2026to 14 Jan 2032
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
China16 sites, 16 recruiting
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100000
Yu, 86-010-85132160, genevector@jwksw.com
- Not yet recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100000
Zhao, 86-010-88326666, genevector@jwksw.com
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610000
Lu, 86-02885422538, lufang@wchscu.cn
- Not yet recruiting
Southwest Hospital, Army Medical University（Southwest Hospital）
Chongqing, Chongqing Municipality, 400000
Liu, 86-023-68766241, genevector@jwksw.com
- Not yet recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000
Sun, 028-0451-86605469, genevector@jwksw.com
- Not yet recruiting
The Second Hospital of Jilin University
Jilin City, Changchun, 130000
Xiao, 86-0431-81136888, genevector@jwksw.com
- Not yet recruiting
The First People's Hospital of Yunnan Province
Kunming, Yunnan, 650000
Ni, 86-0871-63662173, genevector@jwksw.com
- Not yet recruiting
Jiangsu Provincial People's Hospital, The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
Yuan, 86-025-83714511, genevector@jwksw.com
- Not yet recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000
Shen, 86-021-64370045, genevector@jwksw.com
- Not yet recruiting
Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong
Shantou, Guangdong, 515000
Chen, 86-0754-88393527, genevector@jwksw.com
- Not yet recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi, '030000
Duan, 86-0351-8368114, genevector@jwksw.com
- Not yet recruiting
Shanxi Eye Hospital
Taiyuan, Shanxi, 030000
Zhang, 86-0351-8823009, genevector@jwksw.com
- Not yet recruiting
Tianjin Eye Hospital
Tianjin, Tianjin Municipality, 300000
Han, 86-022-27313336, genevector@jwksw.com
- Not yet recruiting
General Hospital of Central Theater Command, Chinese People's Liberation Army
Wuhan, Hubei, 430000
Song, 86-027-50773333, genevector@jwksw.com
- Not yet recruiting
Zhejiang Provincial People's Hospital
Zhejiang, Hangzhou, 310000
Shen, 86-0571-87666666, genevector@jwksw.com
- Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450000
Song, 86-0371-87160551, genevector@jwksw.com
About this study
Official title: A Phase II Study to Evaluate the Safety and Preliminary Efficacy of Subretinal Administration of JWK001 in Patients With Neovascular Age-Related Macular Degeneration (nAMD)
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.
- Being tested
- JWK001, Aflibercept (2.0 mg)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JWK001Drug
JWK001 will be administered as a single subretinal injection in one study eye.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Aflibercept (2.0 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in best-corrected visual acuity (BCVA)
BCVA measured via the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score
Measured: Week 34
Secondary outcomes (7)
Change from baseline in BCVA
BCVA measured via the ETDRS letter score
Measured: Week 50 and Year 5
Change from baseline in central retinal thickness (CRT)
Measured: Week 34, Week 50 and Year 5
Change from baseline in the area of Macular Neovascularization (MNV)
MNV measured via Fluorescein Angiography (FFA)
Measured: Week 34 and Week 50
Change from baseline in leakage area
Leakage area assessed by FFA
Measured: Week 34 and Week 50
Annualized mean number of rescue treatments
Measured: Week 34, Week 50 and Year 5
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.
Measured: Week 34 and Week 50
Frequencies and severities of all safety events
Measured: Week 34 and Year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start31 Aug 2026 (estimated)
- Primary completion15 Aug 2027 (estimated)
- Study completion14 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-Related Macular Degeneration (nAMD) Wet AMDStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Lu, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776522
- Sponsor's protocol ID
- 2024-131
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No