Age-Related Macular Degeneration (ARMD) Clinical Trials

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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

Who is this study for? Patients with Macular Degeneration
Status: Recruiting
Location: See all (53) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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

⁃ Ocular Exclusion Criteria for Study Eye:

• 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 ration \>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 during the last 3 months prior to screening

• Prior treatment with any anti-VEGF-C or anti-VEGF-D inhibitors

Locations
United States
Arizona
Barnet Dulaney Perkins Eye Center
RECRUITING
Mesa
Associated Retina Consultants
ACTIVE_NOT_RECRUITING
Phoenix
California
The Retina Partners
RECRUITING
Encino
Retinal Consultants Med Group
RECRUITING
Sacramento
West Coast Retina Medical Group
WITHDRAWN
San Francisco
Orange County Retina Med Group
RECRUITING
Santa Ana
Macula Retina Vitreous Research Institute
RECRUITING
Torrance
Colorado
Southwest Retina Consultants
RECRUITING
Durango
Florida
Retina Specialty Institute
RECRUITING
Pensacola
Retina Vitreous Assoc of FL
RECRUITING
St. Petersburg
Southern Vitreoretinal Assoc
RECRUITING
Tallahassee
Retina Associates of Florida, LLC
RECRUITING
Tampa
Georgia
Southeast Retina Center
RECRUITING
Augusta
Illinois
University Retina and Macula Associates, PC
RECRUITING
Oak Forest
Maryland
Johns Hopkins Med
RECRUITING
Baltimore
The Retina Care Center
RECRUITING
Baltimore
Retina Group of Washington
RECRUITING
Chevy Chase
Cumberland Valley Retina Consultants
RECRUITING
Hagerstown
Maine
Maine Eye Center
RECRUITING
Portland
Michigan
Foundation for Vision Research
RECRUITING
Grand Rapids
Associated Retinal Consultants
RECRUITING
Royal Oak
Minnesota
VitreoRetinal Surgery, PLLC.
RECRUITING
Saint Louis Park
Missouri
Midwest Vision Research Foundation
RECRUITING
Chesterfield
The Retina Institute
RECRUITING
St Louis
North Carolina
Duke Eye Center
RECRUITING
Durham
Graystone Eye
RECRUITING
Hickory
New Jersey
Envision Ocular, LLC
ACTIVE_NOT_RECRUITING
Bloomfield
NJ Retina - Teaneck
RECRUITING
Teaneck
Nevada
Sierra Eye Associates
ACTIVE_NOT_RECRUITING
Reno
New York
Retina Vit Surgeons/Central NY
RECRUITING
Liverpool
Long Is. Vitreoretinal Consult
RECRUITING
Westbury
Ohio
The Cleveland Clinic Foundation
RECRUITING
Cleveland
OSU Eye Physicians & Surgeons
RECRUITING
Columbus
Pennsylvania
Mid Atlantic Retina - Wills Eye Hospital
RECRUITING
Philadelphia
South Carolina
Charleston Neuroscience Inst
RECRUITING
Ladson
Carolina Eyecare Physicians
RECRUITING
Mt. Pleasant
Tennessee
Charles Retina Institute
RECRUITING
Germantown
Southeastern Retina Associates
RECRUITING
Knoxville
Tennessee Retina PC.
RECRUITING
Nashville
Texas
Retina Res Institute of Texas
RECRUITING
Abilene
Austin Clinical Research LLC
RECRUITING
Austin
Austin Research Center for Retina
RECRUITING
Austin
Retina & Vitreous of Texas
RECRUITING
Bellaire
Retina Consultants of Texas
ACTIVE_NOT_RECRUITING
Bellaire
Texas Retina Associates
RECRUITING
Dallas
Retina Consultants of Texas
ACTIVE_NOT_RECRUITING
Houston
Brown Retina Institute
RECRUITING
San Antonio
Retina Center of Texas
RECRUITING
Southlake
Utah
Retina Associates of Utah, PLLC
RECRUITING
Salt Lake City
Virginia
Piedmont Eye Center
RECRUITING
Lynchburg
Wagner Kapoor Institute
RECRUITING
Norfolk
Washington
Spokane Eye Clinical Research
RECRUITING
Spokane
Other Locations
Puerto Rico
Emanuelli Research and Development Center LLC
RECRUITING
Arecibo
Contact Information
Primary
Reference Study ID Number: BP41670 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. Only)
Time Frame
Start Date: 2020-10-28
Estimated Completion Date: 2028-12-30
Participants
Target number of participants: 251
Treatments
Experimental: Part 1: IVT Injections
Zifibancimig administered in multiple ascending dose levels through IVT injections.
Experimental: Part 2: PD With High Dose
Zifibancimig administered at a high dose through the PD implant. At Week 48, refill-exchange with 100 milligrams/milliliter (mg/mL) of ranibizumab administered through the PD implant.
Experimental: Part 2: PD With Low Dose
Zifibancimig administered at a low dose through the PD implant. At Week 48, refill-exchange with 100 mg/mL of ranibizumab administered through the PD implant.
Experimental: Part 3: PD With High Dose
Zifibancimig administered at a high dose through the PD implant.
Experimental: Part 3: PD With Low Dose
Zifibancimig administered at a low dose through the PD implant.
Active_comparator: Part 3: PD With Ranibizumab
100 mg/mL of ranibizumab administered through the PD implant.
Related Therapeutic Areas
Late-Onset Retinal Degeneration
Age-Related Macular Degeneration (ARMD)
Sponsors
Leads: Hoffmann-La Roche

This content was sourced from clinicaltrials.gov

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