Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD
Conditions
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.
Interventions
DRUGJWK001
JWK001 will be administered as a single subretinal injection in one study eye.
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.
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in best-corrected visual acuity (BCVA) | Week 34 | BCVA measured via the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in BCVA | Week 50 and Year 5 | BCVA measured via the ETDRS letter score |
| 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 | MNV measured via Fluorescein Angiography (FFA) |
| Change from baseline in leakage area | Week 34 and Week 50 | Leakage area assessed by FFA |
| Annualized mean number of rescue treatments | Week 34, Week 50 and Year 5 | — |
| Change from baseline in the 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) score | Week 34 and Week 50 | 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. |
| Frequencies and severities of all safety events | Week 34 and Year 5 | — |
Countries
China
Contacts
CONTACTLu
Outcome results
None listed