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

Boehringer Ingelheim

Status and phase: Begins enrollment this month; Phase 2

Conditions: Macular Degeneration, Age-related; Geographic Atrophy

Treatments: Drug: Pegcetacoplan; Drug: Sham comparator to BI 771716; Drug: BI 771716

Study type: Interventional

Funder types: Industry

Identifiers

NCT06722157

U1111-1308-7923 (Registry Identifier)

1497-0002

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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) 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 72 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 3 patient groups

Arm A: BI 771716

Experimental group

Treatment:

Drug: BI 771716

Arm B: BI 771716 and Sham comparator

Experimental group

Treatment:

Drug: BI 771716

Drug: Sham comparator to BI 771716

Arm C: Pegcetacoplan

Active Comparator group

Treatment:

Drug: Pegcetacoplan