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

NCT03861234 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: 1336-00072017-001221-40
• Study Type: interventional
• Target: 43
• Locations: 3 countries
• Sites: 14

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.

Conditions

Wet Macular Degeneration

Outcome Measures

Primary Outcomes (2)

• SRD-part: Number of Participants With Ocular Dose Limiting Events (DLEs)

  Single rising dose (SRD)-part: Number of participants with ocular dose limiting events (DLEs).

  From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks.

• MRD-part: Number of Participants With Drug Related Adverse Events (AEs)

  Multiple rising dose (MRD)-part: Number of participants with drug related adverse events (AEs)

  From first drug administration until the end of trial (EOT) visit in the MRD part, up to 24 weeks.

Secondary Outcomes (6)

• SRD-part: Number of Participants With Drug Related Adverse Events (AEs)

  From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks.

• SRD-part: Number of Participants With Any Ocular Adverse Events in the Study Eye

  From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks.

• MRD-part: Percentage Change From Baseline in Central Subfield Thickness (CSFT) in the Study Eye at Week 12

  At baseline and at week 12.

• MRD-part: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 12

  At baseline and at Week 12.

• MRD-part: Time to Recurrence in the Study Eye From Last Administration at Each Visit

  From last drug administration at Week 8 until End of Trial, up to 16 weeks.

Study Arms (8)

0.06 mg BI 836880 - SRD part

EXPERIMENTAL

Drug: BI 836880

0.18 mg BI 836880 - SRD part

EXPERIMENTAL

Drug: BI 836880

0.5 mg BI 836880 - SRD part

EXPERIMENTAL

Drug: BI 836880

1 mg BI 836880 - SRD part

EXPERIMENTAL

Drug: BI 836880

2 mg BI 836880 - SRD part

EXPERIMENTAL

Drug: BI 836880

1 mg BI 836880 - cohort 1 MRD part

EXPERIMENTAL

Drug: BI 836880

2 mg BI 836680 - cohort 2 MRD part

EXPERIMENTAL

Drug: BI 836880

2 mg BI 836680 - cohort 3 MRD part

EXPERIMENTAL

Drug: BI 836880

Interventions

BI 836880 DRUG

Solution for Intravitreal (IVT) injection

0.06 mg BI 836880 - SRD part; 0.18 mg BI 836880 - SRD part; 0.5 mg BI 836880 - SRD part; 1 mg BI 836880 - SRD part; 1 mg BI 836880 - cohort 1 MRD part; 2 mg BI 836680 - cohort 2 MRD part; 2 mg BI 836680 - cohort 3 MRD part; 2 mg BI 836880 - SRD part

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (14)

Associated Retina Consultants, Ltd.

Phoenix, Arizona, 85020, United States

Location

New York Eye and Ear Infirmary of Mount Sinai

New York, New York, 10003, United States

Location

Verum Research, LLC

Eugene, Oregon, 97401, United States

Location

Erie Retina Research, LLC

Erie, Pennsylvania, 16507, United States

Location

Retina Research Institute of Texas

Abilene, Texas, 79606, United States

Location

Austin Clinical Research, LLC

Austin, Texas, 78750, United States

Location

Retina Consultants of Texas

Bellaire, Texas, 77401, United States

Location

Charité - Universitätsmedizin Berlin

Berlin, 12200, Germany

Location

Universitätsmedizin Göttingen, Georg-August-Universität

Göttingen, 37075, Germany

Location

Universitätsklinikum Ulm

Ulm, 89075, Germany

Location

Bristol Eye Hospital

Bristol, BS1 2LX, United Kingdom

Location

Royal Liverpool University Hospital

Liverpool, L7 8XP, United Kingdom

Location

Moorfields Eye Hospital

London, EC1V 2PD, United Kingdom

Location

Sunderland Eye Infirmary

Sunderland, SR2 9HP, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Wet Macular Degeneration

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: March 4, 2019
• Study Start: June 27, 2019
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: November 20, 2024
• Results First Posted: November 20, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); US (7); GB (4)