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HORNBILL: A Study to Test Different Doses of BI 764524 in Patients Who Have Had Laser Treatment for a Type of Diabetic Eye Disease Called Diabetic Retinopathy With Diabetic Macular Ischemia (HORNBILL)

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ClinicalTrials.gov Identifier: NCT04424290
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : May 7, 2021
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

This is a study in people with a type of diabetic eye disease called diabetic retinopathy with diabetic macular ischemia. People who have had laser treatment for their diabetic retinopathy can participate in the study. The laser treatment is called panretinal photocoagulation.

The purpose of the study is to find out how well different doses of a medicine called BI 764524 are tolerated. BI 764524 is injected into the eye. The study has 2 parts. In the first part, participants get different doses of BI 764524 only once. Participants are in the first part for about 5 months and visit the study site about 8 times. In the second part, participants are put into different groups by chance. Some participants get BI 764524 injections every 4 weeks. Other participants get sham injections every 4 weeks. A sham injection means that it is not a real injection and contains no medicine. Participants cannot tell whether they get the real injection or a sham injection. For the second part, participants are in the study for about 7 months. During this time, they visit the study site about 7 times. In this study, BI 764524 is given to humans for the first time.

The doctors compare how well people tolerate the BI 764524 injections and the sham injections.

The doctors also regularly check the general health of the participants.


Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Drug: BI 764524 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: This trial will consist of an single rising dose (SRD) part followed by an multiple dosing (MD) part. SRD part will be nonrandomized, open-label, and uncontrolled. MD part will be single-masked, randomized and sham-controlled (Ratio 2:1). Parties masked in the MD part are participant and masked site staff (including investigator). The Intervention model in the MD part is active group versus sham injection (=2 arms).
Primary Purpose: Treatment
Official Title: A First-in Human Trial to Study Safety and Tolerability of Single Rising Intravitreal dOses (Open Label, Non-randomized, Uncontrolled) and in Addition the Early Biological Response of Multiple intravitReal Dosing (Single-masked, raNdomized, Sham-controlled) of BI 764524 in panretinaL Photocoagulation (PRP) Treated proLiferative Diabetic Retinopathy (PDR) Patients With Diabetic Macular Ischemia (DMI) - the HORNBILL Study
Actual Study Start Date : June 12, 2020
Estimated Primary Completion Date : May 18, 2022
Estimated Study Completion Date : May 18, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BI 764524
Single rising dose part followed by a multiple dosing part.
Drug: BI 764524
Powder for solution for intravitreal injection.




Primary Outcome Measures :
  1. Single rising dose (SRD) part: Number of participants with dose limiting events [ Time Frame: 14 weeks ]
    Number of patients with dose limiting events (DLEs) from drug administration till day 8 (7 days after treatment).

  2. Multiple dosing (MD) part: Number of patients with drug related adverse events (AEs) from drug administration till end of study (EOS) [ Time Frame: 22 weeks ]

Secondary Outcome Measures :
  1. SRD part: Number of patients with drug related AEs at EOS [ Time Frame: 14 weeks ]
  2. SRD part: Number of patients with ocular AEs (eye disorders) at EOS [ Time Frame: 14 weeks ]
  3. MD part: Change from baseline of the size of the foveal avascular zone (FAZ) in optical coherence tomography angiography (OCTA) in superficial and deep retinal plexus at week 22 [ Time Frame: 22 weeks ]
  4. MD part: Change from baseline of best corrected visual acuity (BCVA) at Visit 3 [ Time Frame: 4 weeks ]
  5. MD part: Change from baseline of BCVA at Visit 4 [ Time Frame: 8 weeks ]
  6. MD part: Change from baseline of BCVA at Visit 5 [ Time Frame: 12 weeks ]
  7. MD part: Change from baseline of BCVA at Visit 6 [ Time Frame: 16 weeks ]
  8. MD part: Change from baseline of BCVA at Visit 7 [ Time Frame: 22 weeks ]
  9. MD part: Change from baseline of central retinal thickness (SD-OCT) at Visit 3 [ Time Frame: 4 weeks ]
  10. MD part: Change from baseline of central retinal thickness (SD-OCT) at Visit 4 [ Time Frame: 8 weeks ]
  11. MD part: Change from baseline of central retinal thickness (SD-OCT) at Visit 5 [ Time Frame: 12 weeks ]
  12. MD part: Change from baseline of central retinal thickness (SD-OCT) at Visit 6 [ Time Frame: 16 weeks ]
  13. MD part: Change from baseline of central retinal thickness (SD-OCT) at Visit 7 [ Time Frame: 22 weeks ]
  14. MD part: Number of patients with ocular AEs at EOS [ Time Frame: 22 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Single rising dose (SRD) and multiple dosing (MD) part:

  • Pan-retinal photo coagulation treated proliferative diabetic retinopathy (PDR) participants with either no or inactive retinal neovascularization per investigator judgement in the study eye
  • Male or female participants of age ≥ 18 years
  • HbA1c of ≤ 12.0%
  • Best-corrected Visual activity (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.
  • Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use two methods of contraception with at least one of them being a 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 and in the clinical trial protocol.

    --A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is NOT a method of permanent sterilisation. A postmenopausal state is defined as no menses for 2 years without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 2 years of menorrhea, a single FSH measurement is sufficient.

  • Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH GCP) and local legislation prior to admission to the trial

SRD part only:

  • Evidence of diabetic macular ischemia (DMI) per investigator´s judgement, defined as any degree of disruption of retinal vascularity in superficial and/or deep retinal plexus in OCTA
  • Best-corrected VA ≤55 letters (20/80) or worse

MD part only:

  • Presence of significant DMI: Large foveal avascular zone defined as those with ≥0.5 square millimeter (mm2) area in superficial capillary plexus (SCP) present on optical coherence tomography angiography. If FAZ is <0.5mm2 then enlarged peri-foveal intercapillary space in at least 1 quadrant will be sufficient.
  • Best-corrected VA ≤ 70 letters 20/40 or worse

Exclusion Criteria:

SRD part only:

  • Participants receiving intravitreal (IVT) injections for active diabetic macular edema (DME, injections: anti-vascular endothelial growth factor (VEGF), steroids) and macular laser in the study eye in the previous 3 months prior to enrolment
  • Participants receiving anti-VEGF IVT injections for active PDR in the study eye in the previous 3 months prior to enrolment
  • 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)
  • Additional eye disease in the study eye that could compromise best corrected VA (BCVA) with visual field loss, uncontrolled glaucoma (IOP>24), age related macular degeneration, 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 SD-OCT
  • Any intraocular surgery in the study eye within 3 months prior to screening
  • Aphakia or total absence of the posterior capsule. Yttrium aluminium garnet (YAG) laser capsulotomy in the study eye if performed less than 3 months prior to enrolment
  • Participants not expected to comply with the protocol requirements or not expected to complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other condition that, in the investigator´s opinion, makes the patient an unreliable trial participant)
  • Previous participation in this trial or in other trials with IVT injections administered within 3 months.

Further exclusion criteria apply.

MD part only:

  • DME, defined as a central subfield thickness (CST) ≥305 micrometer (μm) for men and ≥290 μm women measured with optovue (Optical coherent tomography) OCT in the study eye
  • Participants receiving IVT injections for active DME (anti-VEGF, steroids) and macular laser in the study eye in the previous 3 months prior to enrolment
  • Participants receiving anti-VEGF IVT injections for active PDR in the study eye in the previous 3 months prior to enrolment
  • Heavily lasered macula in the study eye per investigator's judgement
  • History of vitrectomy in the study eye
  • Epiretinal membrane with extended foveal contour distortion in the study eye per investigator's judgement
  • Clinically significant disorganisation of retinal inner layer (DRIL) 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) Further exclusion criteria apply.

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): NCT04424290


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

Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT04424290    
Other Study ID Numbers: 1436-0001
2019-004432-28 ( EudraCT Number )
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: May 7, 2021
Last Verified: May 2021
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: http://trials.boehringer-ingelheim.com/

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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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Retinal Diseases
Diabetic Retinopathy
Ischemia
Pathologic Processes
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases