Phase 2 N=43 Treatment

A Study to Test Different Doses of BI 836880 in Patients With an Eye Disease Called Wet Age-related Macular Degeneration (wAMD)

Wet Macular Degeneration

Bottom Line

View on ClinicalTrials.gov: NCT03861234 ↗

Enrolled (actual)

Serious AEs

16.7%

Results posted

Nov 2024

Primary outcome: Primary: SRD-part: Number of Participants With Ocular Dose Limiting Events (DLEs) — 0; 0; 0; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: BI 836880 (Drug)
Age: Adult, Older Adult · 55+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Nov 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY SRD-part: Number of Participants With Ocular Dose Limiting Events (DLEs)	0; 0; 0; 0; 0	—
PRIMARY MRD-part: Number of Participants With Drug Related Adverse Events (AEs)	2; 1; 3	—
SECONDARY SRD-part: Number of Participants With Drug Related Adverse Events (AEs)	0; 0; 0; 0; 0	—
SECONDARY SRD-part: Number of Participants With Any Ocular Adverse Events in the Study Eye	1; 0; 1; 1; 2	—
SECONDARY MRD-part: Percentage Change From Baseline in Central Subfield Thickness (CSFT) in the Study Eye at Week 12	-7.7554; -26.5552; -0.1372	—
SECONDARY MRD-part: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 12	-1.2; 1.8; -4.7	—
SECONDARY MRD-part: Time to Recurrence in the Study Eye From Last Administration at Each Visit	8.0; NA; NA	—
SECONDARY MRD-part: Number of Participants With Any Ocular Adverse Events in the Study Eye	5; 1; 9	—

Summary

This is a study in people with an eye disease called wet age-related macular degeneration (wAMD). The purpose of the study is to find out how well different doses of a medicine called BI 836880 are tolerated. People can participate if they are at least 55 years old and if they have new blood vessels in their eyes despite treatment (anti-VEGF therapies). The study has 2 parts. In the first part, people get only 1 dose of BI 836880. This part takes 6 weeks. In the second part, people get 3 times the same dose of BI 836880. This part takes 6 months. BI 836880 is injected into the eye. During the entire study doctors regularly check the health of the participants.

Eligibility Criteria

Inclusion Criteria

SRD part and MRD cohort 1 (treatment-resistant patients with wAMD):

Men and women over the age of 55 with active Choroidal Neovascularisation (CNV) secondary to age-related macular degeneration (AMD) despite anti-Vascualr endothelial growth factor (VEGF) therapies (at least 3 prior injections with the last injection within 16 to 4 weeks before treatment). Active CNV secondary to AMD is to be defined either by recent fluorescein or optical coherence tomography (OCT) angiogram within 4 weeks prior to screening or fluorescein or OCT angiogram obtained prior to first anti VEGF-treatment to confirm the diagnosis and still active according to investigator judgement.
For MRD part only: Central subfield retinal thickness >300 microns in the study eye on Heidelberg Spectralis Spectral Domain Optical Coherence Tomography (SD-OCT).
Presence of sub- and/or intraretinal fluid on SD-OCT in the study eye.
Any active CNV with subfoveal leakage in the study eye as determined by OCT
No subretinal hemorrhage involving the fovea in the study eye.
No significant subfoveal fibrosis or atrophy on SD-OCT in the study eye that, in the opinion of the investigator, is able to prevent improvement in best corrected visual acuity (BCVA) and/or central subfield thickness (CSFT).
Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) VA in the study eye between 75 and 24 letters inclusive (approximately 20/32 and 20/320 or 6/9.5 and 6/95) at screening.
Best-corrected VA in the non-study eye better than best-corrected VA in the study-eye. If both eyes are eligible and have identical VA the investigator may select the study eye.
Male or female patients. Women of childbearing potential (WOCBP) cannot be included. 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.
Signed informed consent consistent with ICH GCP guidelines and local legislation prior to participation in the trial, which includes medication washout and restrictions.
Not under any administrative or legal supervision or under institutionalization due to regulatory or juridical order.

MRD cohort 2 (treatment-naive patients with wAMD):

No subretinal hemorrhage involving the fovea in the study eye.
No significant subfoveal fibrosis or atrophy on SD-OCT in the study eye that, in the opinion of the investigator, is able to prevent improvement in BCVA and/or CSFT.
Male or female patients. Women of childbearing potential (WOCBP) cannot be included. 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.
Signed informed consent consistent with ICH GCP guidelines and local legislation prior to participation in the trial, which includes medication washout and restrictions.
Not under any administrative or legal supervision or under institutionalization due to regulatory or juridical order.
Men and women over the age of 55 with treatment-naïve CNV secondary to AMD.
Any CNV with subfoveal activity in the study eye defined as evidence of sub- and/or intraretinal fluid, or subretinal hyper-reflective material, or angiographic leakage.
Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) VA in the study eye between 80 and 24 letters inclusive (approximately 20/25 and 20/320 or 6/7.5 and 6/95) at screening.
Best-corrected ETDRS VA in the non-study eye 50 letters inclusive (approximately 20/100 or 6/30) or better at screening.
If both eyes are eligible at screening, the study eye is the eye with the worse bestcorrected VA.

MRD cohort 3 (frequently treated patients):

No subretinal hemorrhage involving the fovea in the study eye.
No significant subfoveal fibrosis or atrophy on SD-OCT in the study eye that, in the

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Data sourced from ClinicalTrials.gov (NCT03861234). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.