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NCT06722157Active, not recruitingPhase 2

A Study to Test Whether BI 771716 Helps People With an Advanced Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy

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

Source: ClinicalTrials.gov · Last updated 14 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
202 (actual)
First submitted
5 Dec 2024
Start date
6 Jan 2025
Primary completion date
28 Oct 2026
Lead sponsor
Boehringer Ingelheim
NCT number
NCT06722157

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 202
  • From 6 Jan 2025 to the primary completion date, 28 Oct 2026
  • 46 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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

Other illness

  • 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

Other

  • 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. However, if the fellow eye is to be considered for microperimetry and other analyses (as defined in the trial statistical analysis plan), then eAMD is not allowed in either eye.
  • further exclusion criteria apply

Who the study is looking for

  • 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 of approximately 60% of participants with subfoveal GA lesions are enrolled. Participants with subfoveal GA lesions already in screening at the time the cap has been reached may be considered for randomization.
  • 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

Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (46)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Eye Associates of New Mexico
Coordinator of this site? Confirm its status
AlbuquerqueUnited StatesUnknown status
Southeast Retina Center, PC
Coordinator of this site? Confirm its status
AugustaUnited StatesUnknown status
Austin Clinical Research, LLC
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status
Retina Consultants of Texas-Beaumont-70319
Coordinator of this site? Confirm its status
BeaumontUnited StatesUnknown status
Retina Consultants of Texas-Bellaire-67493
Coordinator of this site? Confirm its status
BellaireUnited StatesUnknown status
Mid Atlantic Retina - Bethlehem
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BethlehemUnited StatesUnknown status
Envision Ocular, LLC
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BloomfieldUnited StatesUnknown status
Ophthalmic Consultants of Boston
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BostonUnited StatesUnknown status
Charleston Neuroscience Institute - Charleston
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CharlestonUnited StatesUnknown status
University of Missouri Health System
Coordinator of this site? Confirm its status
ColumbiaUnited StatesUnknown status
Retina Foundation of the Southwest
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
Connecticut Eye Consultants, PC
Coordinator of this site? Confirm its status
DanburyUnited StatesUnknown status
Rand Eye Institute
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Deerfield BeachUnited StatesUnknown status
Retina Consultants of Minnesota
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EdinaUnited StatesUnknown status
Verum Research, LLC
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EugeneUnited StatesUnknown status
Retina Group of Florida
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Fort LauderdaleUnited StatesUnknown status
Associated Retina Consultants
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GilbertUnited StatesUnknown status
Global Research Management
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GlendaleUnited StatesUnknown status
Mid Atlantic Retina Specialists
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HagerstownUnited StatesUnknown status
Retina Associates of Southern California
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Huntington BeachUnited StatesUnknown status
Retina Consultants of Texas - Katy
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KatyUnited StatesUnknown status
Colorado Retina Associates
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LakewoodUnited StatesUnknown status
University Retina and Macula Associates
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LemontUnited StatesUnknown status
Butchertown Clinical Trials
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LouisvilleUnited StatesUnknown status
Piedmont Eye Center
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LynchburgUnited StatesUnknown status
Mississippi Retina Associates
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MadisonUnited StatesUnknown status
Retinal Consultants Medical Group, Inc
Coordinator of this site? Confirm its status
ModestoUnited StatesUnknown status
Tennessee Retina
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NashvilleUnited StatesUnknown status
Eye Research Foundation
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Newport BeachUnited StatesUnknown status
Illinois Retina Associates - Oak Park
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Oak ParkUnited StatesUnknown status
Phoenix Retina Associates
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PhoenixUnited StatesUnknown status
Associated Retina Consultants, Ltd.
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PhoenixUnited StatesUnknown status
Eye Associates of Pinellas
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Pinellas ParkUnited StatesUnknown status
Red River Research Partners, LLC
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PlanoUnited StatesUnknown status
Retina Consultants of San Diego
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PowayUnited StatesUnknown status
Retinal Consultants Medical Group
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SacramentoUnited StatesUnknown status
Retina Associates of Utah
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Salt Lake CityUnited StatesUnknown status
Retinal Consultants of San Antonio
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San AntonioUnited StatesUnknown status
Retina Consultants of Texas - Schertz
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SchertzUnited StatesUnknown status
Retina Macula Institute of Arizona
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ScottsdaleUnited StatesUnknown status
Spokane Eye Clinic
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SpokaneUnited StatesUnknown status
Retina Vitreous Associates of Florida
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St. PetersburgUnited StatesUnknown status
Retina Consultants of Texas-The Woodlands-67575
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The WoodlandsUnited StatesUnknown status
Bay Area Retina Associates - Walnut Creek
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Walnut CreekUnited StatesUnknown status
Retina Group of New England, PC
Coordinator of this site? Confirm its status
WaterfordUnited StatesUnknown status
Long Island Vitreoretinal Consultants - Westbury
Coordinator of this site? Confirm its status
WestburyUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.