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

  • STATUS
    Recruiting
  • End date
    Feb 16, 2027
  • participants needed
    180
  • sponsor
    Boehringer Ingelheim
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Updated on 11 April 2025
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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.

Details
Condition Macular Degeneration, Age-related, Geographic Atrophy
Age 50years or above
Clinical Study IdentifierNCT06722157
SponsorBoehringer Ingelheim
Last Modified on11 April 2025

Eligibility

 Yes No Not Sure

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) and men able to father a child 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 is provided in the participant information
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)
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 72 subfoveal lesions in the entire trial1 (72 is 40% of the total trial population of 180 participants). No more than 72 participants with subfoveal GA lesions should be enrolled. After the maximum of 72 participants is reached, then any participants with subfoveal GA lesions should not be enrolled
Best Corrected Visual Acuity (BCVA) in the fellow eye must have a better BCVA compared to the study eye
BCVA letter score of ≥24 letters, using the early trial diabetic retinopathy study (ETDRS) chart in the study eye (equivalent to ≥20/320 on the Snellen chart) Note: If both eyes are eligible, investigator is to select the eye with worst BCVA at the baseline visit to be the study eye
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 will be allowed until a maximum is reached of
participants with fellow eye eAMD in the entire trial2 (72 is 40% of the
total trial population of 180 participants). No more than 72 participants with
fellow eye eAMD should be enrolled. After the maximum of 72 participants is
reached, then any participants with fellow eye eAMD should be excluded
Previously received treatment in either eye for GA secondary to AMD within 4 months or 5 half-lives prior to screening, whichever is longer
Previous trial participation receiving oral medication or intravitreal trial medication in the study eye for GA secondary to AMD within 6 months or 5 half-lives prior to screening, whichever is longer
Previously received gene therapy or cell therapy
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 screening in the study eye
further exclusion criteria apply
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