Clinical trial NCT06722157: A Study to Test Whether BI 771716 Helps People With an Advanced Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy
Official title: Randomized, Double-masked, Active-controlled, Multicenter Study to Evaluate Efficacy and Safety of Two Regimens of Intravitreal BI 771716 Against Pegcetacoplan in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration VERDANT Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Macular Degeneration, Age-related
Geographic Atrophy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2024-12-09
Enrollment: 180
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is open to people 50 years or older with an eye condition called geographic atrophy. The purpose of this study is to compare a medicine called BI 771716 with a medicine called pegcetacoplan. BI 771716 is being developed to treat people with geographic atrophy. Pegcetacoplan is a medicine already used to treat people with geographic atrophy.

In this study, participants receive either BI 771716 or pegcetacoplan as injections in the eye.

Participants are in the study for a little longer than a year and visit the study site every 4 weeks. At the visits, the study doctor checks the eyes of the participants. The results are compared between the groups of participants to see whether the treatment works. The study doctor also regularly checks participants' health and takes note of any unwanted effects.


Eligibility criteria: Inclusion criteria

* Age at least 50 years old at the time of randomization visit
* Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
* Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of use are provided in the participant information. Male participants must be ready and able to use either a condom or abstinence as contraceptive measures
* Diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), where the total GA lesion area must be ≥2.5 square millimetres (mm²) and ≤17.5 mm² as measured by Fundus autofluorescence (FAF)

  * If multiple lesions are present in the study eye, at least 1 lesion must have an area of ≥1.25 mm²
  * Note: Fellow eye is not required to have GA
  * Note: subfoveal GA lesions (defined as GA lesions within 1 micron of the foveal center point) will be allowed to be enrolled until a maximum is reached of 36 subfoveal lesions in the entire trial (36 is 20% of the total trial population of 180 participants). No more than 36 participants with subfoveal GA lesions should be enrolled. After the maximum of 36 participants is reached, then any participants with subfoveal GA lesions should not be enrolled
* Fellow eye must have sufficient visual function compared to the study eye, per the investigator's medical judgment in consultation with the patient, to support the patient's daily functioning
* BCVA letter score of ≥24 letters, using the ETDRS chart in the study eye (equivalent to ≥20/320 on the Snellen chart). Note: If both eyes meet eligibility criteria, the eye with the worse visual function per the investigator's medical judgment in consultation with the patient, will be selected as the study eye. If both eyes have similar visual function, the study eye will be selected per the investigator's medical judgment in consultation with the patient
* further inclusion criteria apply

Exclusion criteria

* GA lesions whose area cannot be accurately defined in the study eye
* Exudative neovascular AMD (eAMD) in the study eye

  -- Note: eAMD in the fellow eye is allowed
* Previously received treatment in the study eye for GA secondary to AMD within 4 months or 5 half-lives prior to baseline, whichever is longer
* Previously received an investigational medication (oral or intravitreal) for GA secondary to AMD within 4 months or 5 half-lives prior to baseline, whichever is longer
* Currently enrolled in another investigational device or drug trial, or 30 days or 5 half-lives, whichever is longer since ending another investigational device or drug trial(s) or receiving other investigational treatment(s). Any previous use of gene therapy or cell therapy is not permitted
* Additional eye disease as follows:

  * Any eye disease in the study eye that could compromise BCVA
  * Uncontrolled glaucoma or ocular hypertension with intraocular pressure \>24 millimetre of mercury (mmHg) in study eye
  * History of high myopia \>8 diopters in the study eye
  * Anterior segment and vitreous abnormalities that would preclude adequate observation with spectral domain optical coherence tomography in the study eye
  * Ocular conditions at the discretion of the investigator that might interfere with outcome of the trial in the study eye
  * Active intraocular inflammation in the study eye
  * Active infectious conjunctivitis in either eye
* Prior vitrectomy surgery in the study eye
* History of major intraocular surgeries including major corneal surgery. Uneventful cataract surgery, refractive surgery, oculoplastic surgery, strabismus surgery, and other extraocular surgery may be permitted if they have occurred more than 3 months prior to baseline in the study eye
* further exclusion criteria apply

Primary outcomes:
measure: Slope of change from baseline in square root transformed geographic atrophy (GA) area as measured by fundus autofluorescence (FAF) in the study eye expressed in millimeter (mm)/year
timeFrame: At Baseline , at Week 56
Secondary outcomes:
measure: Change from baseline in square root transformed GA area as measured by FAF in the study eye expressed in mm
timeFrame: At Baseline, at Week 56
measure: Change from baseline in best corrected visual acuity (BCVA) as measured by standardized early trial diabetic retinopathy study (ETDRS) chart in the study eye
timeFrame: At Baseline, at Week 56
measure: Occurrence of BCVA letter loss of ≥15 letters as measured by standardized ETDRS chart in the study eye for at least 2 consecutive visits
timeFrame: Up to Week 56
measure: Occurrence of exudative neovascular age-related macular degeneration (eAMD) in the study eye from first drug administration until Week 56
timeFrame: Up to Week 56
measure: Occurrence of drug-related adverse events (AE) from first drug administration until Week 56
timeFrame: Up to Week 56
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Associated Retina Consultants
state: Arizona
city: Phoenix
country: United States
facility: Associated Retina Consultants, Ltd.
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Retina Associates
state: Arizona
city: Scottsdale
country: United States
facility: Retina Macula Institute of Arizona
state: Arizona
city: Glendale
country: United States
facility: Global Research Management
state: California
city: Huntington Beach
country: United States
facility: Retina Associates of Southern California
state: California
city: Modesto
country: United States
facility: Retinal Consultants Medical Group, Inc
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Poway
country: United States
facility: Retina Consultants of San Diego
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group
state: California
city: Walnut Creek
country: United States
facility: Bay Area Retina Associates - Walnut Creek
state: California
city: Lakewood
country: United States
facility: Colorado Retina Associates
state: Colorado
city: Danbury
country: United States
facility: Connecticut Eye Consultants, PC
state: Connecticut
city: Waterford
country: United States
facility: Retina Group of New England, PC
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Retina Group of Florida
state: Florida
city: Pinellas Park
country: United States
facility: Eye Associates of Pinellas
state: Florida
city: Pompano Beach
country: United States
facility: Rand Eye Institute
state: Florida
city: Saint Petersburg
country: United States
facility: Retina Vitreous Associates of Florida
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center, PC
state: Georgia
city: Lemont
country: United States
facility: University Retina and Macula Associates
state: Illinois
city: Oak Park
country: United States
facility: Illinois Retina Associates - Oak Park
state: Illinois
city: Louisville
country: United States
facility: Butchertown Clinical Trials
state: Kentucky
city: Hagerstown
country: United States
facility: Mid Atlantic Retina Specialists
state: Maryland
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Edina
country: United States
facility: Retina Consultants of Minnesota
state: Minnesota
city: Madison
country: United States
facility: Mississippi Retina Associates
state: Mississippi
city: Columbia
country: United States
facility: University of Missouri Health System
state: Missouri
city: Bloomfield
country: United States
facility: Envision Ocular, LLC
state: New Jersey
city: Albuquerque
country: United States
facility: Eye Associates of New Mexico
state: New Mexico
city: Westbury
country: United States
facility: Long Island Vitreoretinal Consultants - Westbury
state: New York
city: Eugene
country: United States
facility: Verum Research, LLC
state: Oregon
city: Bethlehem
country: United States
facility: Mid Atlantic Retina - Bethlehem
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Neuroscience Institute - Charleston
state: South Carolina
city: Germantown
country: United States
facility: Charles Retina Institute
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Retina
state: Tennessee
city: Austin
country: United States
facility: Austin Clinical Research, LLC
state: Texas
city: Beaumont
country: United States
facility: Retina Consultants of Texas-Beaumont-70319
state: Texas
city: Bellaire
country: United States
facility: Retina Consultants of Texas-Bellaire-67493
state: Texas
city: Dallas
country: United States
facility: Retina Foundation of the Southwest
state: Texas
city: Katy
country: United States
facility: Retina Consultants of Texas - Katy
state: Texas
city: Plano
country: United States
facility: Red River Research Partners, LLC
state: Texas
city: San Antonio
country: United States
facility: Retinal Consultants of San Antonio
state: Texas
city: Schertz
country: United States
facility: Retina Consultants of Texas - Schertz
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas-The Woodlands-67575
state: Texas
city: Salt Lake City
country: United States
facility: Retina Associates of Utah
state: Utah
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
city: Spokane
country: United States
facility: Spokane Eye Clinic
state: Washington
Study officials:
References: