Macular Degeneration, Age-relatedPhase 2VERDANTNCT06722157
A Study to Test Whether BI 771716 Helps People With an Advanced Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy
A Phase 2 study testing BI 771716 and Pegcetacoplan in people with Macular Degeneration, Age-related and Geographic Atrophy, run by Boehringer Ingelheim at 46 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration, Age-related, Geographic Atrophy
- What is being tested?
- BI 771716 and Pegcetacoplan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 46 sitesUnited States
- Study dates
- 6 Jan 2025to 28 Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
- 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
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- 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
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
United States46 sites
Eye Associates of New Mexico
Albuquerque, New Mexico, 87109
Southeast Retina Center, PC
Augusta, Georgia, 30909
Austin Clinical Research, LLC
Austin, Texas, 78750
Retina Consultants of Texas-Beaumont-70319
Beaumont, Texas, 77707
Retina Consultants of Texas-Bellaire-67493
Bellaire, Texas, 77401
Mid Atlantic Retina - Bethlehem
Bethlehem, Pennsylvania, 18017
Envision Ocular, LLC
Bloomfield, New Jersey, 07003
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Charleston Neuroscience Institute - Charleston
Charleston, South Carolina, 29414
University of Missouri Health System
Columbia, Missouri, 65212
Retina Foundation of the Southwest
Dallas, Texas, 75231
Connecticut Eye Consultants, PC
Danbury, Connecticut, 06810
Rand Eye Institute
Deerfield Beach, Florida, 33064
Retina Consultants of Minnesota
Edina, Minnesota, 55435
Verum Research, LLC
Eugene, Oregon, 97401
Retina Group of Florida
Fort Lauderdale, Florida, 33308
Associated Retina Consultants
Gilbert, Arizona, 85297
Global Research Management
Glendale, California, 91204
Mid Atlantic Retina Specialists
Hagerstown, Maryland, 21740
Retina Associates of Southern California
Huntington Beach, California, 92647
Retina Consultants of Texas - Katy
Katy, Texas, 77494
Colorado Retina Associates
Lakewood, Colorado, 80228
University Retina and Macula Associates
Lemont, Illinois, 60439
Butchertown Clinical Trials
Louisville, Kentucky, 40206
Piedmont Eye Center
Lynchburg, Virginia, 24502
Mississippi Retina Associates
Madison, Mississippi, 39110
Retinal Consultants Medical Group, Inc
Modesto, California, 95356
Tennessee Retina
Nashville, Tennessee, 37203
Eye Research Foundation
Newport Beach, California, 92663
Illinois Retina Associates - Oak Park
Oak Park, Illinois, 60304
Associated Retina Consultants, Ltd.
Phoenix, Arizona, 85020
Phoenix Retina Associates
Phoenix, Arizona, 85050
Eye Associates of Pinellas
Pinellas Park, Florida, 33782
Red River Research Partners, LLC
Plano, Texas, 75024
Retina Consultants of San Diego
Poway, California, 92064
Retinal Consultants Medical Group
Sacramento, California, 95825
Retina Associates of Utah
Salt Lake City, Utah, 84107
Retinal Consultants of San Antonio
San Antonio, Texas, 78240
Retina Consultants of Texas - Schertz
Schertz, Texas, 78154
Retina Macula Institute of Arizona
Scottsdale, Arizona, 85255
Spokane Eye Clinic
Spokane, Washington, 99204
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33711
Retina Consultants of Texas-The Woodlands-67575
The Woodlands, Texas, 77384
Bay Area Retina Associates - Walnut Creek
Walnut Creek, California, 94598
Retina Group of New England, PC
Waterford, Connecticut, 06385
Long Island Vitreoretinal Consultants - Westbury
Westbury, New York, 11590
About this study
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
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.
- Being tested
- BI 771716, Pegcetacoplan, Sham comparator to BI 771716
- Medical subject headings
- Macular Degeneration, Geographic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 771716Drug
BI 771716
PegcetacoplanDrug
Also called Syfovre ®
Pegcetacoplan
Sham comparator to BI 771716Drug
Sham comparator to BI 771716
| Study group | Role | What they receive |
|---|---|---|
| Arm A: BI 771716 | Experimental | Not described Receives: Drug: BI 771716 |
| Arm B: BI 771716 and Sham comparator | Experimental | Not described Receives: Drug: BI 771716; Drug: Sham comparator to BI 771716 |
| Arm C: Pegcetacoplan | Active comparator | Not described Receives: Drug: Pegcetacoplan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At Baseline , at Week 56
Secondary outcomes (5)
Change from baseline in square root transformed GA area as measured by FAF in the study eye expressed in mm
Measured: At Baseline, at Week 56
Change from baseline in best corrected visual acuity (BCVA) as measured by standardized early trial diabetic retinopathy study (ETDRS) chart in the study eye
Measured: At Baseline, at Week 56
Occurrence of BCVA letter loss of ≥15 letters as measured by standardized ETDRS chart in the study eye for at least 2 consecutive visits
Measured: Up to Week 56
Occurrence of exudative neovascular age-related macular degeneration (eAMD) in the study eye from first drug administration until Week 56
Measured: Up to Week 56
Occurrence of drug-related adverse events (AE) from first drug administration until Week 56
Measured: Up to Week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start6 Jan 2025
- Primary completion28 Oct 2026 (estimated)
- Study completion28 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular Degeneration, Age-relatedStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722157
- Sponsor's protocol ID
- 1497-0002
- Other IDs
- U1111-1308-7923
- Acronym
- VERDANT
- Status last verified
- May 2026
- First submitted
- 5 Dec 2024
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06722157
- Acronym / sponsor ID
- VERDANT / 1497-0002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 28 Oct 2026 (estimated)
- Study completion
- 28 Oct 2026 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: BI 771716 | Experimental | Drug: BI 771716 |
| Arm B: BI 771716 and Sham comparator | Experimental | Drug: BI 771716, Drug: Sham comparator to BI 771716 |
| Arm C: Pegcetacoplan | Active comparator | Drug: Pegcetacoplan |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
- 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
Key exclusion criteria (17 listed)
- 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.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 771716BI 771716 | Drug | Arm A: BI 771716, Arm B: BI 771716 and Sham comparator |
| PegcetacoplanAlso: Syfovre ®Pegcetacoplan | Drug | Arm C: Pegcetacoplan |
| Sham comparator to BI 771716Sham comparator to BI 771716 | Drug | Arm B: BI 771716 and Sham comparator |
Primary outcome
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
Time frame: At Baseline , at Week 56
5 secondary outcomes
Change from baseline in square root transformed GA area as measured by FAF in the study eye expressed in mm
Time frame: At Baseline, at Week 56
Change from baseline in best corrected visual acuity (BCVA) as measured by standardized early trial diabetic retinopathy study (ETDRS) chart in the study eye
Time frame: At Baseline, at Week 56
Occurrence of BCVA letter loss of ≥15 letters as measured by standardized ETDRS chart in the study eye for at least 2 consecutive visits
Time frame: Up to Week 56
Occurrence of exudative neovascular age-related macular degeneration (eAMD) in the study eye from first drug administration until Week 56
Time frame: Up to Week 56
Occurrence of drug-related adverse events (AE) from first drug administration until Week 56
Time frame: Up to Week 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI 771716 and Pegcetacoplan in people with Macular Degeneration, Age-related and Geographic Atrophy, run by Boehringer Ingelheim at 46 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: At Baseline , at Week 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.