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
- Diseases
- Macular degeneration
- 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
Sites (46)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Eye Associates of New Mexico Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Southeast Retina Center, PC Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| Austin Clinical Research, LLC Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Retina Consultants of Texas-Beaumont-70319 Coordinator of this site? Confirm its status | Beaumont | United States | Unknown status |
| Retina Consultants of Texas-Bellaire-67493 Coordinator of this site? Confirm its status | Bellaire | United States | Unknown status |
| Mid Atlantic Retina - Bethlehem Coordinator of this site? Confirm its status | Bethlehem | United States | Unknown status |
| Envision Ocular, LLC Coordinator of this site? Confirm its status | Bloomfield | United States | Unknown status |
| Ophthalmic Consultants of Boston Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Charleston Neuroscience Institute - Charleston Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| University of Missouri Health System Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| Retina Foundation of the Southwest Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Connecticut Eye Consultants, PC Coordinator of this site? Confirm its status | Danbury | United States | Unknown status |
| Rand Eye Institute Coordinator of this site? Confirm its status | Deerfield Beach | United States | Unknown status |
| Retina Consultants of Minnesota Coordinator of this site? Confirm its status | Edina | United States | Unknown status |
| Verum Research, LLC Coordinator of this site? Confirm its status | Eugene | United States | Unknown status |
| Retina Group of Florida Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
| Associated Retina Consultants Coordinator of this site? Confirm its status | Gilbert | United States | Unknown status |
| Global Research Management Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
| Mid Atlantic Retina Specialists Coordinator of this site? Confirm its status | Hagerstown | United States | Unknown status |
| Retina Associates of Southern California Coordinator of this site? Confirm its status | Huntington Beach | United States | Unknown status |
| Retina Consultants of Texas - Katy Coordinator of this site? Confirm its status | Katy | United States | Unknown status |
| Colorado Retina Associates Coordinator of this site? Confirm its status | Lakewood | United States | Unknown status |
| University Retina and Macula Associates Coordinator of this site? Confirm its status | Lemont | United States | Unknown status |
| Butchertown Clinical Trials Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Piedmont Eye Center Coordinator of this site? Confirm its status | Lynchburg | United States | Unknown status |
| Mississippi Retina Associates Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Retinal Consultants Medical Group, Inc Coordinator of this site? Confirm its status | Modesto | United States | Unknown status |
| Tennessee Retina Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Eye Research Foundation Coordinator of this site? Confirm its status | Newport Beach | United States | Unknown status |
| Illinois Retina Associates - Oak Park Coordinator of this site? Confirm its status | Oak Park | United States | Unknown status |
| Phoenix Retina Associates Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Associated Retina Consultants, Ltd. Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Eye Associates of Pinellas Coordinator of this site? Confirm its status | Pinellas Park | United States | Unknown status |
| Red River Research Partners, LLC Coordinator of this site? Confirm its status | Plano | United States | Unknown status |
| Retina Consultants of San Diego Coordinator of this site? Confirm its status | Poway | United States | Unknown status |
| Retinal Consultants Medical Group Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Retina Associates of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Retinal Consultants of San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Retina Consultants of Texas - Schertz Coordinator of this site? Confirm its status | Schertz | United States | Unknown status |
| Retina Macula Institute of Arizona Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| Spokane Eye Clinic Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| Retina Vitreous Associates of Florida Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| Retina Consultants of Texas-The Woodlands-67575 Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
| Bay Area Retina Associates - Walnut Creek Coordinator of this site? Confirm its status | Walnut Creek | United States | Unknown status |
| Retina Group of New England, PC Coordinator of this site? Confirm its status | Waterford | United States | Unknown status |
| Long Island Vitreoretinal Consultants - Westbury Coordinator of this site? Confirm its status | Westbury | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.