Health TrialsbyHealthPanel

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

ConditionNeovascular Age-Related Macular Degeneration (nAMD) Wet AMD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50-85
SponsorWest China Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • JWK001

    Drug

    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.

Treatment groups

50 Participants
are divided into 3 treatment groups
Group A: JWK001 3×10^10 vg/eye groupExperimental treatment 1 intervention
Group B: JWK001 6×10^10 vg/eye groupExperimental treatment 1 intervention
Group C: Aflibercept Active Comparator GroupActive comparator 1 intervention

Trial outcomes

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

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

West China Hospital

Lead sponsor

Source ClinicalTrials.gov
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