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

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ClinicalTrials.gov Identifier: NCT03861234
Recruitment Status : Not yet recruiting
First Posted : March 4, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The main objective is to investigate ocular and systemic safety and tolerability as well as disease improvement of BI 836880 after a single Intravitreal (IVT) injection and after multiple IVT injections of several doses.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
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).
Estimated Study Start Date : May 8, 2019
Estimated Primary Completion Date : October 26, 2020
Estimated Study Completion Date : November 23, 2020

Resource links provided by the National Library of Medicine


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




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) from drug administration till end of trial (EOT) [ Time Frame: Up to 43 days ]
  2. Single Rising Dose (SRD) part: Number of patients with any ocular Adverse Events (AEs)(eye disorders) [ Time Frame: Up to 43 days ]
  3. Multiple Rising Dose (MRD) part: Percent change from baseline in Central Subfield Thickness (CSFT) 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) 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 (eye disorders) [ Time Frame: Up to 169 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 screening). Active CNV secondary to AMD is to be defined either by recent fluorescein angiogram within 4 weeks prior to screening or fluorescein angiogram obtained prior to first anti VEGF-treatment to confirm the diagnosis and still active according to investigator judgement.
  • No more than 18 months elapsed since the first anti-VEGF therapy in the study eye
  • For Multiple Rising Dose (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 Optical coherence tomography (OCT)
  • No subretinal hemorrhage involving the fovea in the study eye
  • No subfoveal fibrosis or atrophy on SD-OCT in the study eye
  • 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.
  • Female subjects must be of non-childbearing potential
  • 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

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
  • Previous participation in this trial or in other trials with Intravitreal (IVT) injections or in trials for treatment of Wet Age-related Macular Degeneration (wAMD).
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03861234


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03861234     History of Changes
Other Study ID Numbers: 1336-0007
2017-001221-40 ( EudraCT Number )
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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). Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to:

  1. find information in order to request access to clinical study data, for listed studies.
  2. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement'.

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

Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases