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Also known as RO7250284
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/...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 7 | PHASE3 | Surabgene Lomparvovec, RGX-314, ABBV-6628 |
| Ocular Therapeutix Inc | OCUL | 3 | PHASE3 | OTX-TKI |
| 4D Molecular Therapeutics, Inc. | FDMT | 3 | PHASE3 | 4D-150 |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE3 | Aflibercept, Pozelimab, Cemdisiran |
| Novartis AG Sponsored ADR | NVS | 5 | PHASE2 | Iptacopan, GT005, FWY003 |
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901 |
| Kodiak Sciences, Inc. | KOD | 1 | PHASE3 | Tarcocimab tedromer, Tabirafusp tedromer |
| Hoffmann-La Roche | RHHBY | 10 | PHASE3 | Ranibizumab, Susvimo, RO7965032, OpRegen, Faricimab |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | ONS-5010 |
| Adverum Biotechnologies, Inc. | ADVM | 4 | PHASE3 | Ixo-vec, ADVM-022 |
| Apellis Pharmaceuticals, Inc. | APLS | 1 | PHASE2 | APL-3007 |
| Amgen Inc. | AMGN | 1 | PHASE3 | ABP 938, Aflibercept |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-81201887 |
| Ocugen Inc | OCGN | 1 | PHASE3 | OCU410 |
| Alcon AG | ALC | 1 | PHASE1 | AR-14034 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR402663 |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE1 | ARO-033 |
| Bayer | BAYRY | 2 | - | Aflibercept |
Zifibancimig is being developed for the treatment of macular degeneration, specifically neovascular age-related macular degeneration. It is an investigational therapy and has not been approved for any indication. The clinical program has studied it in adults aged 50 years and older with this eye condition.
Zifibancimig is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor of the clinical program evaluating the drug in ophthalmology. No other developers or partners are listed for this asset.
Zifibancimig is in Phase 1 clinical development. One Phase 1 trial has been completed, and there are currently no active trials listed. The drug remains investigational and has not received regulatory approval for any use.
Zifibancimig has been evaluated in one completed Phase 1 trial, NCT04567303, titled Study of Zifibancimig in Participants With Neovascular Age-related Macular Degeneration. The trial enrolled 177 participants across the United States and Puerto Rico and was randomized, double-blind, and active-controlled.
Zifibancimig is not FDA approved. It is an investigational small molecule in Phase 1 clinical development for macular degeneration. The only listed trial has been completed, and no regulatory approval has been granted for this drug.