This is a first in-human study to investigate the safety, tolerability and efficacy of zifibancimig administered through intravitreal (IVT) injections and via the port delivery (PD) implant in participants with neovascular age-related macular degeneration (nAMD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
177
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.
Participants will receive ranibizumab 100 mg/mL through the PD implant
Participants will receive intraocular refillable device that is surgically inserted into the eye for continuous delivery of drugs into the vitreous.
Percentage of Participants With Ocular and Systemic (Non-ocular) Adverse Events (AEs)
Time frame: Part 1: Baseline up to Week 24; Parts 2 & 3: Baseline up to Week 48
Percentage of Participants With Ocular AEs During the Post-operative and Follow-up Periods
Time frame: Parts 2 and 3: From Day 1 to Week 4 and during follow-up period (up to Week 48)
Percentage of Participants With Adverse Events of Special Interest (AESIs) Including Ocular AESIs
Time frame: Part 1: Baseline up to Week 24; Parts 2 and 3: Baseline up to Week 48
Percentage of Participants With Ocular AESIs During the Post-operative and Follow-up Periods
Time frame: Parts 2 and 3: From Day 1 to Week 4 and during follow-up period (up to Week 48)
Duration of Ocular AESIs
Time frame: Part 1: Baseline up to Week 24; Parts 2 and 3: Baseline up to Week 48
Duration of Ocular AESIs During the Post-operative and Follow-up Periods
Time frame: Parts 2 and 3: From Day 1 to Week 4 and during follow-up period (up to Week 48)
Percentage of Participants With Adverse Device Effects (ADEs)
Time frame: Parts 2 and 3: Baseline up to Week 48
Duration of ADEs
Time frame: Parts 2 and 3: Baseline up to Week 48
Percentage of Participants With Anticipated Serious ADEs (ASADEs)
Time frame: Parts 2 and 3: Baseline up to Week 48
Duration of ASADEs
Time frame: Parts 2 and 3: Baseline up to Week 48
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Barnet Dulaney Perkins Eye Center
Mesa, Arizona, United States
Associated Retina Consultants
Phoenix, Arizona, United States
The Retina Partners
Encino, California, United States
Retinal Consultants Med Group
Sacramento, California, United States
Orange County Retina Med Group
Santa Ana, California, United States
Southwest Retina Consultants
Durango, Colorado, United States
Retina Vitreous Assoc of FL
St. Petersburg, Florida, United States
Southern Vitreoretinal Assoc
Tallahassee, Florida, United States
Southeast Retina Center
Augusta, Georgia, United States
University Retina and Macula Associates, PC
Oak Forest, Illinois, United States
...and 27 more locations
Change From Baseline in Early Treatment Diabetic Retinopathy Study - Best Corrected Visual Acuity (ETDRS-BCVA) Score at Week 48
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.
Time frame: Part 3: Baseline (baseline visit, before implant insertion), and Week 48
Maximum Observed Concentration (Cmax) of Zifibancimig in Blood and Aqueous Humor (AH)
Time frame: Part 1: Baseline up to Week 24; Parts 2 and 3: Baseline up to Week 144
Time of Maximum Concentration Observed (Tmax) of Zifibancimig in Blood and AH
Time frame: Part 1: Baseline up to Week 24; Parts 2 and 3: Baseline up to Week 144
Concentration at the End of a Dosing Interval Before the Next Dose Administration (Ctrough) of Zifibancimig in Blood and AH
Time frame: Part 1: Baseline up to Week 24; Parts 2 and 3: Baseline up to Week 144
Area Under the Curve (AUC) of Zifibancimig in Blood and AH
Time frame: Part 1: Baseline up to Week 24; Parts 2 and 3: Baseline up to Week 144
Percentage of Participants Who did not Meet Supplemental Treatment Criteria for the PD Implant With Zifibancimig
Time frame: Part 3: Week 36, Week 40, and Week 44
Percentage of Participants Who Gained or Lost ≥15, ≥10 ≥5 or ≥0 Letters in ETDRS-BCVA Score From Baseline to Week 48
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.
Time frame: Part 3: Baseline to Week 48
Change From Baseline in Central Subfield Thickness (CST) at Week 48
Time frame: Part 3: Baseline, and Week 48
Change From Baseline Over Time in CST
Time frame: Part 3: Baseline to end of follow-up period (up to Week 144)