Home › Trials › NCT06722157

Testing a new medicine for advanced age-related macular degeneration

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

Phase 2 Interventional Boehringer Ingelheim · NCT06722157

This study is testing a new eye medicine for people aged 50 and older with a severe form of age-related macular degeneration to see if it works better than the current treatment.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment180 (estimated)
Ages50 Years and up
SexAll
SponsorBoehringer Ingelheim Industry-sponsored
Locations48 sites (Gilbert, Arizona and 47 other locations)
Trial IDNCT06722157 on ClinicalTrials.gov

What this trial studies

This study involves participants aged 50 and older who have geographic atrophy, a severe form of age-related macular degeneration. It aims to compare the effectiveness of a new medication called BI 771716 against an existing treatment, pegcetacoplan, through eye injections. Participants will be monitored over a period of just over a year with regular visits every four weeks to assess their eye health and any side effects. The goal is to determine if BI 771716 provides better outcomes than the current standard treatment.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50 and older diagnosed with geographic atrophy secondary to age-related macular degeneration.

Not a fit: Patients with less severe forms of macular degeneration or those under 50 years old may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new treatment option for patients suffering from geographic atrophy.

How similar studies have performed: Other studies have shown promise in treating geographic atrophy, but the specific approach of BI 771716 is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Gilbert, Arizona and 47 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Macular Degeneration, Age-relatedGeographic Atrophy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.