Phase 1: IVB103 Injection（Low dose） for nAMD

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are IVB103 Injection（Low dose）, IVB103 Injection（Intermediate dose）, or IVB103 Injection（High dose）. The registry lists allocation as randomized. The goal of this clinical trial is to measure the safety and how well it works of IVB103 injection in subjects with nAMD.

They plan to enroll about 18 people at Chengdu. Taking part typically means genetic testing or a gene-targeted therapy plus check-ins.

Official title (unrewritten)

An Exploratory Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of IVB103 Injection in Subjects With Neovascular (Wet) Agerelated Macular Degeneration (nAMD).

Interventions: IVB103 Injection（Low dose）, IVB103 Injection（Intermediate dose）, IVB103 Injection（High dose）

Primary outcome (registry wording): Incidence of DLTs

Who it is for (from inclusion criteria)

• Ages 50 Years to any
• Age≥ 50 years old, gender is not limited;
• Confirmed presence of active CNV secondary to nAMD in the macula of study eye;
• The total area of all types of lesions in the study eye \< 30 mm2;
• The Best Corrected Visual Acuity (BCVA) detected by the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart in the study eye is 63\~19 letters (including boundary values), which is equivalent to 20/63 to 20/400 of the Snellen Eye Chart;
• The BCVA detected by the ETDRS eye chart in the non-study eye is not less than 19 letters, which is equivalent to 20/400 of the Snellen Eye Chart;
• The study eye has received at least 2 episodes of intravitreal anti- VEGF therapy within 6 months prior to screening and has responded within two weeks of the lead-in period of anti-VEGF standard therapy (Aflibercept injection);