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

• Status: Recruiting
• Trial end date: 2022-06-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim

Criteria

Inclusion Criteria:

• Men and women over the age of 55 with active Choroidal Neovascularisation (CNV) secondary to Age-related macular degeneration (AMD) despite anti-Vascular Endothelial Growth Factor (VEGF) therapies (at least 3 prior injections with the last injection within 12 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 >350 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) Visual Acuity (VA) in the study eye between 70 and 24 letters inclusive (approximately 20/40 and 20/320 or 6/12 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)1 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. A list of contraception methods meeting these criteria is provided in the patient information

• 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

• Further inclusion criteria apply

Exclusion criteria:

• Additional eye disease in the study eye that could compromise best corrected Visual Acuity (VA)(BCVA) with visual field loss, uncontrolled glaucoma (Intra-Ocular Pressure (IOP)>24), clinically significant diabetic maculopathy, history of ischemic optic neuropathy or retinal vascular occlusion, symptomatic vitreomacular traction, or genetic disorders such as retinitis pigmentosa); history of high myopia > 8 diopters in the study eye. Anterior segment and vitreous abnormalities in the study eye that would preclude adequate observation with Spectral Domain Optical Coherence Tomography (SD-OCT)

• Any prior intraocular surgery in the study eye other then uneventful lens replacement for cataract within 3 months prior to screening

• Aphakia or total absence of the posterior capsule. Yttrium aluminum garnet (YAG) laser capsulotomy permitted, more than 3 month prior to enrollment in the study eye

• Current or planned use of medications known to be toxic to the retina, lens or optic nerve (e.g. desferoxamine, chloroquine/hydrochloroquine, chlorpromazine, phenothiazines, tamoxifen, nicotinic acid, and ethambutol)

• Medical history or condition: Uncontrolled diabetes mellitus, with hemoglobin A1c (HbA1c) > 10%, myocardial infarction or stroke within 12 months of screening, active bleeding disorder, concomitant use of warfarin or anticoagulation therapy (use of antiplatelet therapy such as aspirin is allowed), major surgery within 1 month of screening or when planned within the study period, hepatic impairment, uncontrolled hypertension

• Patients with a clinically relevant abnormal screening haematology, blood chemistry, or urinalysis, if the abnormality defines a significant disease as defined in other exclusion criteria. AST or ALT greater than 2.0-fold the upper limit of normal at screening. Patients with total bilirubin 2.5x upper limit of normal at screening.

• Patient with impaired renal function defined as calculated GFR< 30 mL/min

• Significant alcohol or drug abuse within past 2 years per investigator judgement

• Participation in trials:

• Previous participation in this trial.

• Previous participation in other trials for treatment of wAMD with systemic administration and/orif washout period from last administration is shorter than 3 months.

• MRD cohort 1: Previous participation in other trials for treatment of wAMD with IVT injections in the study eye if washout period from last administration/injection is shorter than 3 months.

• MRD cohort 2: No previous IVT injections for wAMD in the study eye

• Significant disease or other medical conditions (as determined by medical history, examination and clinical investigations at screening) that may, in the opinion of the investigator result in the any of the following:

• Put the patient at risk because of participation in the study,

• Influence the results of the study,

• Cause concern regarding the patient's ability to participate in the study.

• Known hypersensitivity to fluorescein or any of the ingredients used in the Investigational Medicinal Product (IMP) formulation, or any of the medications used

• Active intraocular inflammation in the study eye

• Active infectious conjunctivitis in either eye