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Tests treatment safety and results for Polypoidal Choroidal Vasculopathy (PCV)
Official title Efficacy and Durability of a Personalized Treat-and-extend Regimen of Faricimab for Treatment-naive Polypoidal Choroidal Vasculopathy
ClinicalTrials.gov ID: NCT07461441
What this study is testing
What is Faricimab Injection [Vabysmo]?
Faricimab Injection [Vabysmo] is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for polypoidal choroidal vasculopathy (pcv).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the Efficacy of a personalized treat-and-extend regimen of faricimab for treatment-naive polypoidal choroidal vasculopathy
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- Potential participants are eligible to be included in the study only if all of the following criteria apply: [Ocular Conditions]
- Presence of active polypoidal lesions in the macula as shown by Indocyanine green angiography (ICGA) AND presence of serosanguinous maculopathy...
- BCVA score must be ≤ 78 and ≥ 24 letters at 4 meters starting distance using early treatment diabetic retinopathy study (ETDRS) visual acuity charts...
- Greatest liner dimension (GLD) of the total lesion area (branching vascular network [BVN] + polypoidal lesion) \< 5400 μm (equivalent to 9 macular...
- Signed Informed Consent Form
You likely can't join if
- Potential participants are excluded from the study if any of the following criteria apply: [Ocular Conditions] in the Study Eye
- Previous treatment with any anti-VEGF drugs or faricimab or investigational drugs at any time prior to Baseline.
- Previous use of intraocular or periocular steroids within the 6-month period prior to Baseline.
- Macular laser photocoagulation (focal/grid) or PDT at any time prior to Baseline and peripheral laser photocoagulation within 3 months prior to...
- Treatment with investigational therapy (device, drug, or traditional medicine with the exception of vitamins and minerals) within 3 months prior to...
- Concomitant conditions or ocular disorders in the study eye at Screening or Baseline which could, in the opinion of the Investigator, prevent...
See the full eligibility criteria
Who can join
- Potential participants are eligible to be included in the study only if all of the following criteria apply: [Ocular Conditions]
- Presence of active polypoidal lesions in the macula as shown by Indocyanine green angiography (ICGA) AND presence of serosanguinous maculopathy, i.e., exudative or hemorrhagic features involving the macula on color...
- BCVA score must be ≤ 78 and ≥ 24 letters at 4 meters starting distance using early treatment diabetic retinopathy study (ETDRS) visual acuity charts at both Screening and Baseline.
- Greatest liner dimension (GLD) of the total lesion area (branching vascular network [BVN] + polypoidal lesion) \< 5400 μm (equivalent to 9 macular photocoagulation study [MPS] Disc Area) as delineated by ICGA. [Systemic...
- Signed Informed Consent Form
- Age ≥ 50 years at the time of signing Informed Consent Form
- Participants who are able to comply with the study protocol, in the investigator's judgment
- For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception (will be defined in details in protocol)
What rules you out
- Potential participants are excluded from the study if any of the following criteria apply: [Ocular Conditions] in the Study Eye
- Previous treatment with any anti-VEGF drugs or faricimab or investigational drugs at any time prior to Baseline.
- Previous use of intraocular or periocular steroids within the 6-month period prior to Baseline.
- Macular laser photocoagulation (focal/grid) or PDT at any time prior to Baseline and peripheral laser photocoagulation within 3 months prior to Baseline.
- Treatment with investigational therapy (device, drug, or traditional medicine with the exception of vitamins and minerals) within 3 months prior to initiation of study treatment on study Day 1
- Concomitant conditions or ocular disorders in the study eye at Screening or Baseline which could, in the opinion of the Investigator, prevent response to study treatment or may confound interpretation of study results...
- Presence of subfoveal geographic atrophy or extensive retinal pigment epithelial atrophy involving the central subfield that, in the opinion of the investigator, may limit visual potential.
- Presence of subfoveal fibrosis or scarring involving the central subfield as identified on color fundus photography or OCT.
- Presence of subretinal or sub-RPE hemorrhage involving ≥50% of the total lesion area, or any hemorrhage obscuring the fovea.
- Any active intraocular or periocular infection or active intraocular inflammation (IOI) in study eye or fellow eye at Screening or Baseline.
- Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) \> 25 mmHg on medication, or according to Investigator's judgment, at Screening or Baseline.
- Any PCV masquerades like macular aneurysms, macular telangiectasia, etc. in study eye. Add these EC fro both eyes Potential participants are excluded from the study if any of the following criteria apply:
- History of idiopathic or autoimmune-associated uveitis in either eye
- Active ocular inflammation or suspected or active ocular or periocular infection in either eye on study Day 1 [Systemic Conditions]
- Systemic anti-VEGF therapy any time prior to Baseline.
- Any major illness or major surgical procedure within 1 month before screening
- Active cancer within the 12 months prior to study Day 1 except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of \ 12 months
- Continuous use of any medications and treatments (which will be indicated in the Prohibited Therapy section in protocol)
- Systemic treatment for suspected or active systemic infection on study Day 1
- Uncontrolled blood pressure, defined as systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg while the participant is at rest on study Day 1
- History of stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to study Day 1
- History of other disease, metabolic dysfunction, physical examination finding, or historical or current clinical laboratory findings giving reasonable suspicion of a condition that contraindicates the use of the...
- History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab injection, study-related procedure preparations (including fluorescein and...
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 28 days after the final dose of faricimab
The study team makes the final eligibility decision.
Where it's taking place
- Daegu, Namgu, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Daegu, Namgu, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.