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Zifibancimig · 1 trial · 1 indication
ETDRS-BCVA will be used to quantify visual acuity. BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
| Arm | Type | Description |
|---|---|---|
| Part 1: IVT Injections | EXPERIMENTAL | Zifibancimig administered in multiple ascending dose levels through IVT injections. |
| Part 2: PD With High Dose | EXPERIMENTAL | Zifibancimig administered at a high dose through the PD implant, followed by ranibizumab, 100 milligrams per milliliter (mg/mL), administered through the PD implant. |
| Part 2: PD With Low Dose | EXPERIMENTAL | Zifibancimig administered at a low dose through the PD implant, followed by ranibizumab, 100 mg/mL, administered through the PD implant. |
| Part 3: PD With High Dose | EXPERIMENTAL | Zifibancimig administered at a high dose through the PD implant, followed by ranibizumab, 100 mg/mL, administered through PD implant. |
| Part 3: PD With Low Dose | EXPERIMENTAL | Zifibancimig administered at a low dose through the PD implant, followed by ranibizumab, 100 mg/mL, administered through PD implant. |
| Part 3: PD With Ranibizumab | ACTIVE_COMPARATOR | 100 mg/mL of ranibizumab administered through the PD implant. |
| Name | Type | Description |
|---|---|---|
| Zifibancimig | DRUG | Part 1: multiple ascending doses by IVT injection. Each participant will receive zifibancimig at a constant volume of 50 microliter (µL) in the study eye. Part 2: participants will be randomized to one of two dose levels of zifibancimig in the PD implant. Part 3: Participants will receive one of the two dose levels of zifibancimig in the PD implant. |
| Ranibizumab | DRUG | Participants will receive ranibizumab 100 mg/mL through the PD implant |
| Port Delivery Platform | DEVICE | Participants will receive intraocular refillable device that is surgically inserted into the eye for continuous delivery of drugs into the vitreous. |
Part 1, Part 2 and Part 3 Inclusion Criteria: * Willing to allow AH collection Part 1 and Part 2 Ocular Inclusion Criteria for Study Eye: * Choroidal neovascularization (CNV) exclusively due to age-related macular degeneration (AMD) * Anti-vascular endothelial growth factor (VEGF) or anti-VEGF/...
Zifibancimig is an investigational small molecule being developed for macular degeneration, specifically neovascular age-related macular degeneration. It is in Phase 1 clinical development and is not yet approved by the FDA. The drug is being studied in a clinical trial enrolling participants aged 50 years and older.
Zifibancimig is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting a Phase 1 clinical trial of the drug in the United States and Puerto Rico for the treatment of neovascular age-related macular degeneration.
Zifibancimig is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is active but not recruiting participants, with a planned enrollment of 177 participants.
Zifibancimig is being studied in one Phase 1 clinical trial with the identifier NCT04567303. The trial is titled 'Study of Zifibancimig in Participants With Neovascular Age-related Macular Degeneration' and is active but not recruiting. It is a randomized, double-blind, active-controlled study enrolling 177 participants in the United States and Puerto Rico.
Zifibancimig is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for neovascular age-related macular degeneration. The drug is being evaluated in a clinical trial to assess its safety and efficacy, but it has not yet received regulatory approval.