ACTIVE_NOT_RECRUITING

Study of Zifibancimig in Participants With Neovascular Age-related Macular Degeneration

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Three-part, Phase I/II Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Zifibancimig Following Intravitreal Administration of Multiple Ascending Doses and Continuous Delivery From the Port Delivery in Patients With Neovascular Age-related Macular Degeneration

Quick Facts

Study Start:2020-10-28

Study Completion:2026-08-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04567303

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Willing to allow AH collection * Choroidal neovascularization (CNV) exclusively due to age-related macular degeneration (AMD) * Anti-vascular endothelial growth factor (VEGF) or anti-VEGF/Angiopoietin-2 (Ang-2) IVT treatment-naïve, or pre-treated with anti-VEGF or anti-VEGF/Ang-2 no less than two months prior to Day 1 * Sufficiently clear ocular media and adequate pupillary dilatation to allow for analysis and grading by the central reading center of fundus photography (FP), fluorescein angiography (FA), fundus autofluorescence (FAF), and spectral domain optical coherence tomography (SD-OCT) images * Decreased BCVA attributable primarily to nAMD, with BCVA letter score of 78 to 34 letters (inclusive) on ETDRS-like charts at screening. In case both eyes of a participant are eligible, the eye with the lower BCVA score should become the study eye * CNV exclusively due to AMD * Diagnosis of nAMD within 36 months prior to the screening visit * Previous treatment with at least one IVT anti-VEGF or anti-VEGF/Ang-2 administrations IVT for nAMD. The last IVT administration must have occurred at least 21 days prior to the screening visit * Demonstrated response to prior IVT anti-VEGF or anti-VEGF/Ang-2 treatment since diagnosis * Availability of historical VA data prior to the first anti-VEGF or anti-VEGF/Ang-2 treatment for nAMD * Sufficiently clear ocular media and adequate pupillary dilatation to allow for analysis and grading * Decreased BCVA attributable primarily to nAMD with letter score of 78 to 34 letters (inclusive) or better on ETDRS-like charts * History of vitrectomy surgery, submacular surgery, other intraocular surgery, or any planned surgical intervention during the study period * Cataract surgery without complications within three months preceding the screening visit or planned during the study period * Aphakia or absence of the posterior capsule. Previous violation of the posterior capsule is also an exclusion criterion, unless it occurred as a result of yttrium-aluminum garnet laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation * Prior macular treatment with verteporfin, external beam radiation therapy, transpupillary thermotherapy, or any type of laser photocoagulation * Prior treatment with IVT corticosteroids or implant (e.g., triamcinolone, ozurdex, iluvien) * Subretinal hemorrhage \>50% of the total lesion area and/or involving the fovea * Subfoveal fibrosis or subfoveal atrophy * Retinal pigment epithelial tear involving the macula * History of vitreous hemorrhage, rhegmatogenous retinal detachment, glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery, and corneal transplant * History of rhegmatogenous retinal tears or peripheral retinal breaks within three months prior to the screening visit * Actual or history of myopia \>-8 diopters * Uncontrolled ocular hypertension or glaucoma (defined as intraocular pressure \[IOP\] \>25 millimeters of mercury (mm Hg) or a cup to disc ratio \>0.8, despite treatment with antiglaucoma medication) and any such condition the Investigator determines may require a glaucoma-filtering surgery during a participant's participation in the study * Concurrent intraocular conditions (e.g., cataract, diabetic retinopathy, epiretinal membrane with traction, macular hole) that, in the opinion of the Investigator, could either: require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition; or likely contribute to loss of BCVA over the study period if allowed to progress untreated; or preclude any visual improvement due to substantial structural damage * Concurrent conjunctival, Tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye (e.g., scarring, thinning, mass) that may affect the implantation, subsequent tissue coverage, and refill-exchange procedure of the PD implant * Prior treatment with any medication for geographic atrophy (GA) during the last 3 months prior to screening * Prior treatment with any anti-VEGF-C or anti-VEGF-D inhibitors * BCVA letter score using ETDRS charts of \< 34 letters * Treatment with IVT anti-VEGF or anti-VEGF/Ang-2 agents within one week prior to Day 1 (concurrent treatment with SUSVIMO\^TM in the fellow eye is not exclusionary) * CNV due to causes other than nAMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, uveitis or central serous chorioretinopathy * Prior participation in a clinical trial involving anti-VEGF drugs within six months prior to the screening visit, other than ranibizumab, aflibercept, or faricimab including approved biosimilars * Active intraocular inflammation (grade trace or above), infectious conjunctivitis, keratitis, scleritis, or endophthalmitis * History of uveitis, including history of any intraocular inflammation following intravitreal therapy * Prior treatment with brolucizumab * Prior gene therapy for nAMD	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

* Willing to allow AH collection
* Choroidal neovascularization (CNV) exclusively due to age-related macular degeneration (AMD)
* Anti-vascular endothelial growth factor (VEGF) or anti-VEGF/Angiopoietin-2 (Ang-2) IVT treatment-naïve, or pre-treated with anti-VEGF or anti-VEGF/Ang-2 no less than two months prior to Day 1
* Sufficiently clear ocular media and adequate pupillary dilatation to allow for analysis and grading by the central reading center of fundus photography (FP), fluorescein angiography (FA), fundus autofluorescence (FAF), and spectral domain optical coherence tomography (SD-OCT) images
* Decreased BCVA attributable primarily to nAMD, with BCVA letter score of 78 to 34 letters (inclusive) on ETDRS-like charts at screening. In case both eyes of a participant are eligible, the eye with the lower BCVA score should become the study eye
* CNV exclusively due to AMD
* Diagnosis of nAMD within 36 months prior to the screening visit
* Previous treatment with at least one IVT anti-VEGF or anti-VEGF/Ang-2 administrations IVT for nAMD. The last IVT administration must have occurred at least 21 days prior to the screening visit
* Demonstrated response to prior IVT anti-VEGF or anti-VEGF/Ang-2 treatment since diagnosis
* Availability of historical VA data prior to the first anti-VEGF or anti-VEGF/Ang-2 treatment for nAMD
* Sufficiently clear ocular media and adequate pupillary dilatation to allow for analysis and grading
* Decreased BCVA attributable primarily to nAMD with letter score of 78 to 34 letters (inclusive) or better on ETDRS-like charts
* History of vitrectomy surgery, submacular surgery, other intraocular surgery, or any planned surgical intervention during the study period
* Cataract surgery without complications within three months preceding the screening visit or planned during the study period
* Aphakia or absence of the posterior capsule. Previous violation of the posterior capsule is also an exclusion criterion, unless it occurred as a result of yttrium-aluminum garnet laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation
* Prior macular treatment with verteporfin, external beam radiation therapy, transpupillary thermotherapy, or any type of laser photocoagulation
* Prior treatment with IVT corticosteroids or implant (e.g., triamcinolone, ozurdex, iluvien)
* Subretinal hemorrhage \>50% of the total lesion area and/or involving the fovea
* Subfoveal fibrosis or subfoveal atrophy
* Retinal pigment epithelial tear involving the macula
* History of vitreous hemorrhage, rhegmatogenous retinal detachment, glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery, and corneal transplant
* History of rhegmatogenous retinal tears or peripheral retinal breaks within three months prior to the screening visit
* Actual or history of myopia \>-8 diopters
* Uncontrolled ocular hypertension or glaucoma (defined as intraocular pressure \[IOP\] \>25 millimeters of mercury (mm Hg) or a cup to disc ratio \>0.8, despite treatment with antiglaucoma medication) and any such condition the Investigator determines may require a glaucoma-filtering surgery during a participant's participation in the study
* Concurrent intraocular conditions (e.g., cataract, diabetic retinopathy, epiretinal membrane with traction, macular hole) that, in the opinion of the Investigator, could either: require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition; or likely contribute to loss of BCVA over the study period if allowed to progress untreated; or preclude any visual improvement due to substantial structural damage
* Concurrent conjunctival, Tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye (e.g., scarring, thinning, mass) that may affect the implantation, subsequent tissue coverage, and refill-exchange procedure of the PD implant
* Prior treatment with any medication for geographic atrophy (GA) during the last 3 months prior to screening
* Prior treatment with any anti-VEGF-C or anti-VEGF-D inhibitors
* BCVA letter score using ETDRS charts of \< 34 letters
* Treatment with IVT anti-VEGF or anti-VEGF/Ang-2 agents within one week prior to Day 1 (concurrent treatment with SUSVIMO\^TM in the fellow eye is not exclusionary)
* CNV due to causes other than nAMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, uveitis or central serous chorioretinopathy
* Prior participation in a clinical trial involving anti-VEGF drugs within six months prior to the screening visit, other than ranibizumab, aflibercept, or faricimab including approved biosimilars
* Active intraocular inflammation (grade trace or above), infectious conjunctivitis, keratitis, scleritis, or endophthalmitis
* History of uveitis, including history of any intraocular inflammation following intravitreal therapy
* Prior treatment with brolucizumab
* Prior gene therapy for nAMD

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Clinical Trials

STUDY_DIRECTOR

Hoffmann-La Roche

Study Locations (Sites)

Barnet Dulaney Perkins Eye Center

Mesa, Arizona, 85206

United States

Associated Retina Consultants

Phoenix, Arizona, 85020

United States

The Retina Partners

Encino, California, 91436

United States

Retinal Consultants Med Group

Sacramento, California, 95841

United States

Orange County Retina Med Group

Santa Ana, California, 92705

United States

Macula Retina Vitreous Research Institute

Torrance, California, 90503-3270

United States

Southwest Retina Consultants

Durango, Colorado, 81303

United States

Retina Specialty Institute

Pensacola, Florida, 32503

United States

Retina Vitreous Assoc of FL

St. Petersburg, Florida, 33711

United States

Southern Vitreoretinal Assoc

Tallahassee, Florida, 32308

United States

Retina Associates of Florida, LLC

Tampa, Florida, 33609

United States

Southeast Retina Center

Augusta, Georgia, 30909

United States

University Retina and Macula Associates, PC

Oak Forest, Illinois, 60452

United States

Maine Eye Center

Portland, Maine, 04101

United States

The Retina Care Center

Baltimore, Maryland, 21209

United States

Johns Hopkins Med

Baltimore, Maryland, 21287

United States

Retina Group of Washington

Chevy Chase, Maryland, 20815

United States

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740

United States

Foundation for Vision Research

Grand Rapids, Michigan, 49546

United States

Associated Retinal Consultants

Royal Oak, Michigan, 48073

United States

VitreoRetinal Surgery, PLLC.

Saint Louis Park, Minnesota, 55416

United States

Midwest Vision Research Foundation

Chesterfield, Missouri, 63017

United States

The Retina Institute

St Louis, Missouri, 63128

United States

Sierra Eye Associates

Reno, Nevada, 89502

United States

Envision Ocular, LLC

Bloomfield, New Jersey, 07003

United States

NJ Retina - Teaneck

Teaneck, New Jersey, 07666-1704

United States

Retina Vit Surgeons/Central NY

Liverpool, New York, 13088

United States

Long Is. Vitreoretinal Consult

Westbury, New York, 11590

United States

Duke Eye Center

Durham, North Carolina, 27705

United States

Graystone Eye

Hickory, North Carolina, 28602

United States

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195

United States

OSU Eye Physicians & Surgeons

Columbus, Ohio, 43212

United States

Mid Atlantic Retina - Wills Eye Hospital

Philadelphia, Pennsylvania, 19107

United States

Charleston Neuroscience Inst

Ladson, South Carolina, 39456

United States

Carolina Eyecare Physicians

Mt. Pleasant, South Carolina, 29464

United States

Charles Retina Institute

Germantown, Tennessee, 38138

United States

Southeastern Retina Associates

Knoxville, Tennessee, 37922

United States

Tennessee Retina PC.

Nashville, Tennessee, 37203

United States

Retina Res Institute of Texas

Abilene, Texas, 79606

United States

Austin Research Center for Retina

Austin, Texas, 78705

United States

Austin Clinical Research LLC

Austin, Texas, 78750

United States

Retina & Vitreous of Texas

Bellaire, Texas, 77401

United States

Retina Consultants of Texas

Bellaire, Texas, 77401

United States

Texas Retina Associates

Dallas, Texas, 75231

United States

Retina Consultants of Texas

Houston, Texas, 77030

United States

Brown Retina Institute

San Antonio, Texas, 78251-4551

United States

Retina Center of Texas

Southlake, Texas, 76092

United States

Retina Associates of Utah, PLLC

Salt Lake City, Utah, 84107

United States

Piedmont Eye Center

Lynchburg, Virginia, 24502

United States

Wagner Kapoor Institute

Norfolk, Virginia, 23502

United States

Spokane Eye Clinical Research

Spokane, Washington, 99204

United States

Collaborators and Investigators

Sponsor: Hoffmann-La Roche

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-10-28

Study Completion Date2026-08-01

Study Record Updates

Study Start Date2020-10-28

Study Completion Date2026-08-01

Terms related to this study

Additional Relevant MeSH Terms

Macular Degeneration