Phase II Study of Subretinal JWK001 for Neovascular Age-Related Macular Degeneration
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
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
Treatments tested in this trial
- JWK001
- Aflibercept (2.0 mg)
Treatment groups
50 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov