Phase 2/3Not yet recruitingAge-related condition
This is a 96-week, Multicenter Study in Patients With Neovascular AMD That Evaluates OCUL101 for Efficacy, Safety, Durability, and Pharmacokinetics, Comparing it With Another Treatment. The Study Will be Conducted in Two Parts, Part A and Part B. (STAT)
A Phase II/III Multicenter, Randomized, Masked, Active Comparator-Controlled Study to Evaluate the Safety and Efficacy of Two Doses of OCUL101, an Anti-VEGF and Anti-Complement C5, Bi-specific Humanized Antibody-Like "Trap" in Participants With Neovascular Age-Related Macular Degeneration With or Without Geographic Atrophy - STAT Study
- Sponsor
- Shenzhen Oculgen Biomedical Technology Co., Ltd. (Industry)
- Enrollment
- 255 planned
- Conditions
- Adults With Neovascular Age-related Macular Degeneration
- Interventions
- bispecific anti-VEGF and anti-complement
- Ages
- adults, older adults
- Registry
- NCT07520318
Full record on ClinicalTrials.gov
From the registry
Oculgen has begun a study of an investigational drug called OCUL101 as a possible treatment for neovascular AMD. An investigational drug is one that has not been approved by regulatory agencies, such as the Food and Drug Administration (FDA) in the United States (US), the European Medicines Agency (EMA) in the European Union (EU), or others. A comparator drug, Eylea® (aflibercept), will also be used in this study. Aflibercept is approved by regulatory agencies to treat neovascular AMD. VEGF-A (vascular endothelial growth factor A) is a protein released by the body in response to certain conditions that encourages the eye to form new blood vessels that are weak and leaky. This can lead to leakage of fluid and swelling in the macula; the part of the eye that helps you see clearly. C5 (component 5) is a part of the immune system released when there is ongoing damage to the eye such as when you have neovascular AMD. When it becomes too active in the eye, it can cause inflammation and further damage, leading to thinning of the back of the eye, a condition called geographic atrophy (GA).…
Primary outcomes
- Part A: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
- Part B: Change from baseline in mean BCVA score.
History
Study completion expected
Primary completion expected
Started
Last registry update
Registered