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Wet Macular DegenerationPhase 1/2NCT03861234

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

A Phase 1/2 study testing BI 836880 in people with Wet Macular Degeneration, run by Boehringer Ingelheim at 14 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Wet Macular Degeneration
What is being tested?
BI 836880
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
14 sitesin 3 countries
Study dates
27 Jun 2019to 1 Nov 2023
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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 opinion of the investigator and with the endorsement of the Sponsor, is able to prevent improvement in BCVA.
  • 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.
  • 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.
  • 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.
  • If both eyes are eligible at screening, the study eye is the eye with the worse bestcorrected VA.
  • Men and women over the age of 55 with diagnosed wAMD that:
  • require frequent wAMD SoC (28-56 days between the last 3 treatments)
  • have had ≥ 3 previous treatments with IVT SoC (ranibizumab, aflibercept, or bevacizumab) in the study eye
  • had the last SoC injection ≥ 4 weeks, but no more than 8 weeks, before the first administration of the study drug
  • have been on SoC treatment ≥ 6 months and are within 3 years from initial wAMD diagnosis in the study eye

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

14 sites in 3 countries.

14 sites in 3 countries

United States7 sites

  • Retina Research Institute of Texas

    Abilene, Texas, 79606

  • Austin Clinical Research, LLC

    Austin, Texas, 78750

  • Retina Consultants of Texas

    Bellaire, Texas, 77401

  • Erie Retina Research, LLC

    Erie, Pennsylvania, 16507

  • Verum Research, LLC

    Eugene, Oregon, 97401

  • New York Eye and Ear Infirmary of Mount Sinai

    New York, New York, 10003

  • Associated Retina Consultants, Ltd.

    Phoenix, Arizona, 85020

Other trials in United States

United Kingdom4 sites

  • Bristol Eye Hospital

    Bristol, BS1 2LX

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP

  • Moorfields Eye Hospital

    London, EC1V 2PD

  • Sunderland Eye Infirmary

    Sunderland, SR2 9HP

Other trials in United Kingdom

Germany3 sites

  • Charité - Universitätsmedizin Berlin

    Berlin, 12200

  • Universitätsmedizin Göttingen, Georg-August-Universität

    Göttingen, 37075

  • Universitätsklinikum Ulm

    Ulm, 89075

Other trials in Germany

About this study

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).

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.

Being tested
BI 836880
Medical subject headings
Wet Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BI 836880Drug

    Solution for Intravitreal (IVT) injection

Study groups in NCT03861234
Study groupRoleWhat they receive
0.06 mg BI 836880 - SRD partExperimentalNot described
Receives: Drug: BI 836880
0.18 mg BI 836880 - SRD partExperimentalNot described
Receives: Drug: BI 836880
0.5 mg BI 836880 - SRD partExperimentalNot described
Receives: Drug: BI 836880
1 mg BI 836880 - SRD partExperimentalNot described
Receives: Drug: BI 836880
2 mg BI 836880 - SRD partExperimentalNot described
Receives: Drug: BI 836880
1 mg BI 836880 - cohort 1 MRD partExperimentalNot described
Receives: Drug: BI 836880
2 mg BI 836680 - cohort 2 MRD partExperimentalNot described
Receives: Drug: BI 836880
2 mg BI 836680 - cohort 3 MRD partExperimentalNot described
Receives: Drug: BI 836880

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

  2. 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)

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

Secondary outcomes (6)

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

    Single rising dose (SRD)-part: Number of participants with drug related adverse events (AEs).

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

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

    Single rising dose (SRD)-part: Number of participants with any ocular adverse events in the study eye.

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

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

    Multiple rising dose (MRD)-part: Central subfield thickness was measured using Spectral domain-optical coherence tomography (SD-OCT) with the assessment performed by a qualified person and only specified OCT equipment was used. Optical coherence tomography angiography (OCT-A), a non-invasive imaging technique providing high-resolution volumetric blood flow information without the use of dye was also performed by a qualified person, and only specified device(s) were used. OCT images were sent to an independent CRC for evaluation. A detailed manual for OCT image acquisition and data transmission was provided. CSFT was investigated after 3 doses of BI 836880 in the MRD part of the trial at Week 12.

    Measured: At baseline and at week 12.

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

    Multiple rising dose (MRD)-part): Visual acuity (VA) measured by 'early treatment diabetic retinopathy study' letter charts.

    BCVA was measured using the early treatment diabetic retinopathy study (ETDRS) VA chart starting at a test distance of 4 m. The BCVA score was the number of letters read correctly by the patient. The assessment was performed by a trained person under specified conditions regarding examination room and equipment.

    Measured: At baseline and at Week 12.

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

    Multiple rising dose (MRD)-part: Time to recurrence was assessed in the MRD part from last trial drug administration to occurrence of any of the following in the study eye, leading to the use of wet age-related macular degeneration (wAMD) rescue medication as decided by the investigator:

    • Increase in Central Subfield Thickness (CFST) ≥75 μm with a decrease in Best Corrected Visual Acuity (BCVA) of ≥ 5 letters compared to Visit 5, OR
    • Decrease in BCVA of >5 letters compared to baseline (Visit 2), due to worsening wAMD activity, OR
    • Decrease in BCVA of ≥10 letters compared to the best prior BCVA, due to worsening wAMD activity From above criteria, if Visit 5 BCVA/CSFT assessment data is missing, BCVA/CSFT values available earlier than Visit 5 will be used. The last trial drug administration is strictly referring to the third injection, if a patient doesn't complete three injections, the patient will not be evaluated for time to recurrence endpoint and will be censored.

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

  6. MRD-part: Number of Participants With Any Ocular Adverse Events in the Study Eye

    Multiple rising dose (MRD)-part: Number of participants with any ocular adverse events in the study eye.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2019
  2. Study start27 Jun 2019
  3. Primary completion1 Nov 2023
  4. Study completion1 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03861234
Sponsor's protocol ID
1336-0007
Other IDs
2017-001221-40, 2017
Status last verified
Oct 2024
First submitted
26 Feb 2019
Last updated
20 Nov 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BI 836880 in people with Wet Macular Degeneration, run by Boehringer Ingelheim at 14 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 37 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States, United Kingdom, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SRD-part: Number of Participants With Ocular Dose Limiting Events (DLEs) (time frame: From drug administration until the end of trial (EOT) visit in the SRD part, up to 6 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03861234.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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