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

• ClinicalTrials.gov Identifier: NCT03861234
• Recruitment Status: Suspended
• First Posted: March 4, 2019
• Last Update Posted: March 9, 2022
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Wet Macular Degeneration	Drug: BI 836880	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety, Tolerability and Pharmacodynamics of Single Rising Intravitreal and Multiple Rising Intravitreal Doses of BI 836880 in Patients With wAMD (Open Label, Non-randomized, Uncontrolled).
• Actual Study Start Date: June 27, 2019
• Estimated Primary Completion Date: October 10, 2022
• Estimated Study Completion Date: January 2, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: BI 836880; Single Rising Dose part followed by a Multiple Rising Dose part	Drug: BI 836880; Solution for Intravitreal (IVT) injection

Outcome Measures

Primary Outcome Measures :

1. Single Rising Dose (SRD) part: Number of patients with ocular dose limiting events (DLEs) from drug administration till end of trial (EOT) [ Time Frame: Up to 43 days ]
2. Multiple Rising Dose (MRD) part: Number of patients with drug related Adverse Events (AEs) from drug administration till end of trial (EOT) [ Time Frame: Up to 169 days ]

Secondary Outcome Measures :

1. Single Rising Dose (SRD) part: Number of patients with drug related Adverse Events (AEs) [ Time Frame: Up to 43 days ]
2. Single Rising Dose (SRD) part: Number of patients with any ocular Adverse Events (AEs) in the study eye [ Time Frame: Up to 43 days ]
3. Multiple Rising Dose (MRD) part: Percent change from baseline in Central Subfield Thickness (CSFT) in the study eye at week 12, for each dose [ Time Frame: Baseline, Week 12 ]
4. Multiple Rising Dose (MRD) part: Change from baseline in Best Corrected Visual Acuity (BCVA) in the study eye at week 12 [ Time Frame: Baseline, Week 12 ]
5. Multiple Rising Dose (MRD) part: Time to recurrence after the last treatment [ Time Frame: Up to 169 days ]
6. Multiple Rising Dose (MRD) part: Number of patients with any ocular AEs in the study eye [ Time Frame: Up to 169 days ]

Eligibility Criteria

• Ages Eligible for Study: 55 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

SRD part and MRD cohort 1:

-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:

• Centralsubfield 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:

• 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.

Exclusion criteria:

• Additional eye disease in the study eye that could compromise best corrected VA (BCVA) with visual field loss, uncontrolled glaucoma (intraocular pressure (IOP)> 24 mmHg on more than 2 consecutive measurements prior to screening), clinically significant diabetic maculopathy, history of ischemic optic neuropathy or retinalvascular 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 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 1 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. desferoximine, 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. Aspartate aminotransferase (AST) or alanine aminotransferase (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 glomerular filtration rate (GFR) < 30 mL/min.
• Significant alcohol or drug abuse within past 2 years per investigator judgement.
• Further exclusion criteria apply.

Contacts and Locations

Locations

United States, California

Stanford University Medical Center

Palo Alto, California, United States, 94303

United States, Maryland

Cumberland Valley Retina Consultants, PC.

Hagerstown, Maryland, United States, 21740

United States, New York

New York Eye and Ear Infirmary of Mount Sinai

New York, New York, United States, 10003

United States, Oregon

Verum Research, LLC

Eugene, Oregon, United States, 97401

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

United States, Texas

Retina Research Institute of Texas

Abilene, Texas, United States, 79606

Austin Clinical Research, LLC

Austin, Texas, United States, 78750

Retina Consultants of Texas

Bellaire, Texas, United States, 77401

Germany

Charité - Universitätsmedizin Berlin

Berlin, Germany, 12200

Universitätsmedizin Göttingen, Georg-August-Universität

Göttingen, Germany, 37075

Augenzentrum am St. Franziskus-Hospital Münster

Münster, Germany, 48145

Universitätsklinikum Ulm

Ulm, Germany, 89075

United Kingdom

Bristol Eye Hospital

Bristol, United Kingdom, BS1 2LX

Royal Liverpool University Hospital

Liverpool, United Kingdom, L7 8XP

Moorfields Eye Hospital

London, United Kingdom, EC1V 2PD

Sponsors and Collaborators

Boehringer Ingelheim

More Information

Additional Information:

Related Info 

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT03861234
• Other Study ID Numbers: 1336-0007; 2017-001221-40 ( EudraCT Number )
• First Posted: March 4, 2019
• Last Update Posted: March 9, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

1. studies in products where Boehringer Ingelheim is not the license holder;
2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datasharing

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Macular Degeneration; Wet Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases