Diabetic RetinopathyPhase 1/2HORNBILLNCT04424290
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
A Phase 1/2 study testing BI 764524 in people with Diabetic Retinopathy, run by Boehringer Ingelheim at 19 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- BI 764524
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 12 Jun 2020to 28 Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
- 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.
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- 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 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.
- Best-corrected VA ≤55 letters (20/80) or worse
- MD part only:
- Presence of significant DMI: large foveal avascular zone defined as those with ≥0.5mm2 area in superficial vascular complex (SVC) present on optical coherence tomography angiography. If FAZ is <0.5mm2 then enlarged peri-foveal inter-capillary space in at least 1 quadrant will be sufficient.
- If both eyes are eligible, the investigator may select either eye to be the study eye.
- Best-corrected VA ≤ 85 letters (20/20) or worse
Who cannot join
- 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
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- 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
- 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.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States13 sites
Austin Research Center for Retina, PLLC
Austin, Texas, 78705
Retina Consultants of Texas
Bellaire, Texas, 77401
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
Joslin Diabetes Center
Boston, Massachusetts, 02115
Raj K. Maturi, MD PC
Carmel, Indiana, 46290
Cleveland Clinic
Cleveland, Ohio, 44195
Trinity Research
Dothan, Alabama, 36301
Long Island Vitreoretinal Consultants
Great Neck, New York, 11021
Valley Retina Institute, PA
McAllen, Texas, 78503
New York Eye and Ear Infirmary of Mount Sinai
New York, New York, 10003
Florida Retina Institute
Orlando, Florida, 32806
Stanford University Medical Center
Palo Alto, California, 94303
Retina Consultants of Texas
The Woodlands, Texas, 77384
United Kingdom6 sites
Bradford Royal Infirmary
Bradford, BD9 6RJ
Bristol Eye Hospital
Bristol, BS1 2LX
Southend University Hospital
Essex, SS0 0RY
Gloucestershire Royal Hospital
Gloucester, GL1 3NN
Moorfields Eye Hospital
London, EC1V 2PD
Sunderland Eye Infirmary
Sunderland, SR2 9HP
About this study
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
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.
Read more
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.
- Conditions
- Diabetic Retinopathy
- Being tested
- BI 764524, Sham control of BI 764524
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 764524Drug
BI 764524
Sham control of BI 764524Drug
Sham control of BI 764524
| Study group | Role | What they receive |
|---|---|---|
| Single-rising dose part - low dose BI 764524 | Experimental | Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of low dose BI 764524. Receives: Drug: BI 764524 |
| Single-rising dose part - medium dose BI 764524 | Experimental | Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of medium dose BI 764524. Receives: Drug: BI 764524 |
| Single-rising dose part - high dose BI 764524 | Experimental | Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of high dose BI 764524. Receives: Drug: BI 764524 |
| Multiple dosing part - Sham | Sham comparator | Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received three sham intravitreal injections, each separated by 4 weeks. Receives: Drug: Sham control of BI 764524 |
| Multiple dosing part - high dose BI 764524 | Experimental | Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received three intravitreal injections of high dose BI 764524, each separated by 4 weeks. Receives: Drug: BI 764524 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single-rising Dose (SRD) Part - The Number of Patients With Dose Limiting Events (DLEs) From Drug Administration Until Day 8
Single-rising dose (SRD) part - The number of patients with dose limiting events (DLEs) from drug administration until Day 8 (7 days after treatment).
Measured: From drug administration (day 1) till day 8, Up to 7±2 days.
Multiple Dosing (MD) Part - the Number of Patients With Drug-related Adverse Events (AEs) From Drug Administration Until End of Trial.
Multiple dosing (MD) part - the number of patients with drug-related Adverse Events (AEs) from drug administration until End of Trial.
Measured: From drug administration (day 1) till End of Trial, up to 23 weeks.
Secondary outcomes (17)
SRD Part - Number of Patients With Drug-related Adverse Events at End of Trial
SRD part - Number of patients with drug-related Adverse Events at End of Trial.
Measured: From drug administration (day 1) till End of Trial, up to 15 weeks.
SRD Part - Number of Patients With Ocular Adverse Events (Eye Disorders) at End of Trial
SRD part - Number of patients with ocular Adverse Events (eye disorders) at End of Trial.
Measured: From drug administration (day 1) till End of Trial, up to 15 weeks.
MD Part - Number of Patients With Ocular Adverse Events (Eye Disorders) at End of Trial
MD part - Number of patients with ocular Adverse Events (eye disorders) at End of Trial.
Measured: From drug administration (day 1) till End of Trial, up to 23 weeks.
MD Part - Change From Baseline of the Size of the FAZ in FTR at Visit 5
MD part - Change from baseline of the size of the foveal avascular zone (FAZ) in optical coherence tomography angiography (OCTA) in full thickness retina (FTR) at Visit 5. Results calculated as [Baseline data]-[Visit 5 data].
Measured: Baseline (day 0) and Visit 5 (day 85±7).
MD Part - Change From Baseline of the Size of the FAZ in SVC at Visit 5
MD part - Change from baseline of the size of the foveal avascular zone (FAZ) in optical coherence tomography angiography (OCTA) in superficial vascular complex (SVC) at Visit 5. Results calculated as [Baseline data]-[Visit 5 data].
Measured: Baseline (day 0) and Visit 5 (day 85±7).
MD Part - Change From Baseline of the Size of the FAZ in FTR at Visit 7
MD part - Change from baseline of the size of the foveal avascular zone (FAZ) in optical coherence tomography angiography (OCTA) in full thickness retina (FTR) at Visit 7. Results calculated as [Baseline data]-[Visit 7 data].
Measured: Baseline (day 0) and Visit 7 (day 155±7).
MD Part - Change From Baseline of the Size of the FAZ in SVC at Visit 7
MD part - Change from baseline of the size of the foveal avascular zone (FAZ) in optical coherence tomography angiography (OCTA) in superficial vascular complex (SVC) at Visit 7. Results calculated as [Baseline data]-[Visit 7 data].
Measured: Baseline (day 0) and Visit 7 (day 155±7).
MD Part - Change From Baseline of Best Corrected Visual Acuity (BCVA) at Visit 3
Change from baseline of best corrected visual acuity (BCVA) at Visit 3. BCVA was measured using the early treatment diabetic retinopathy study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meter. The BCVA score was the number of letters read correctly by the patient. Results calculated as [Baseline data]-[Visit 3 data].
Measured: Baseline (day 0) and Visit 3 (day 29±7).
MD Part - Change From Baseline of Best Corrected Visual Acuity (BCVA) at Visit 4
Change from baseline of best corrected visual acuity (BCVA) at Visit 4. BCVA was measured using the early treatment diabetic retinopathy study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meter. The BCVA score was the number of letters read correctly by the patient. Results calculated as [Baseline data]-[Visit 4 data].
Measured: Baseline (day 0) and Visit 4 (day 57±7).
MD Part - Change From Baseline of Best Corrected Visual Acuity (BCVA) at Visit 5
Change from baseline of best corrected visual acuity (BCVA) at Visit 5. BCVA was measured using the early treatment diabetic retinopathy study (ETDRS) visual acuity (VA) chart starting at a test distance of 5 meter. The BCVA score was the number of letters read correctly by the patient. Results calculated as [Baseline data]-[Visit 5 data].
Measured: Baseline (day 0) and Visit 5 (day 85±7).
MD Part - Change From Baseline of Best Corrected Visual Acuity (BCVA) at Visit 6
Change from baseline of best corrected visual acuity (BCVA) at Visit 6. BCVA was measured using the early treatment diabetic retinopathy study (ETDRS) visual acuity (VA) chart starting at a test distance of 6 meter. The BCVA score was the number of letters read correctly by the patient. Results calculated as [Baseline data]-[Visit 6 data].
Measured: Baseline (day 0) and Visit 6 (day 113±7).
MD Part - Change From Baseline of Best Corrected Visual Acuity (BCVA) at Visit 7
Change from baseline of best corrected visual acuity (BCVA) at Visit 7. BCVA was measured using the early treatment diabetic retinopathy study (ETDRS) visual acuity (VA) chart starting at a test distance of 7 meter. The BCVA score was the number of letters read correctly by the patient. Results calculated as [Baseline data]-[Visit 7 data].
Measured: Baseline (day 0) and Visit 7 (day 155±7).
MD Part - Change From Baseline of Central Retinal Thickness (CRT) at Visit 3
MD part - Change from baseline of central retinal thickness (CRT) in Spectral domain optical coherence tomography (SD-OCT) at Visit 3. Results calculated as [Baseline data]-[Visit 3 data].
Measured: Baseline (day 0) and Visit 3 (day 29±7).
MD Part - Change From Baseline of Central Retinal Thickness (CRT) at Visit 4
MD part - Change from baseline of central retinal thickness (CRT) in Spectral domain optical coherence tomography (SD-OCT) at Visit 4. Results calculated as [Baseline data]-[Visit 4 data].
Measured: Baseline (day 0) and Visit 4 (day 57±7)
MD Part - Change From Baseline of Central Retinal Thickness (CRT) at Visit 5
MD part - Change from baseline of central retinal thickness (CRT) in Spectral domain optical coherence tomography (SD-OCT) at Visit 5. Results calculated as [Baseline data]-[Visit 5 data].
Measured: Baseline (day 0) and Visit 5 (day 85±7).
MD Part - Change From Baseline of Central Retinal Thickness (CRT) at Visit 6
MD part - Change from baseline of central retinal thickness (CRT) in Spectral domain optical coherence tomography (SD-OCT) at Visit 6. Results calculated as [Baseline data]-[Visit 6 data].
Measured: Baseline (day 0) and Visit 6 (day 113±7).
MD Part - Change From Baseline of Central Retinal Thickness (CRT) at Visit 7
MD part - Change from baseline of central retinal thickness (CRT) in Spectral domain optical coherence tomography (SD-OCT) at Visit 7. Results calculated as [Baseline data]-[Visit 7 data].
Measured: Baseline (day 0) and Visit 7 (day 155±7).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start12 Jun 2020
- Primary completion28 Apr 2023
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424290
- Sponsor's protocol ID
- 1436-0001
- Other IDs
- 2019-004432-28, 2019
- Acronym
- HORNBILL
- Status last verified
- Apr 2024
- First submitted
- 8 Jun 2020
- Last updated
- 22 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Publications
Chong V, Nguyen QD, Sepah Y, Giani A, Pearce E. HORNBILL: a phase I/IIa trial examining the safety, tolerability and early response of BI 764524 in patients with diabetic retinopathy and diabetic macular ischaemia-rationale, study design and protocol. Trials. 2022 Aug 17;23(1):669. doi: 10.1186/s13063-022-06527-y.
PubMed 35978329
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04424290
- Acronym / sponsor ID
- HORNBILL / 1436-0001
- Conditions
- Diabetic Retinopathy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Posted 22 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Single-rising dose part - low dose BI 764524 | Experimental | Drug: BI 764524Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of low dose BI 764524. |
| Single-rising dose part - medium dose BI 764524 | Experimental | Drug: BI 764524Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of medium dose BI 764524. |
| Single-rising dose part - high dose BI 764524 | Experimental | Drug: BI 764524Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of high dose BI 764524. |
| Multiple dosing part - Sham | Sham comparator | Drug: Sham control of BI 764524Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received three sham intravitreal injections, each separated by 4 weeks. |
| Multiple dosing part - high dose BI 764524 | Experimental | Drug: BI 764524Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received three intravitreal injections of high dose BI 764524, each separated by 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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%
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 764524BI 764524 | Drug | Multiple dosing part - high dose BI 764524, Single-rising dose part - high dose BI 764524, Single-rising dose part - low dose BI 764524, Single-rising dose part - medium dose BI 764524 |
| Sham control of BI 764524Sham control of BI 764524 | Drug | Multiple dosing part - Sham |
Primary outcome
Single-rising Dose (SRD) Part - The Number of Patients With Dose Limiting Events (DLEs) From Drug Administration Until Day 8
Time frame: From drug administration (day 1) till day 8, Up to 7±2 days.
Single-rising dose (SRD) part - The number of patients with dose limiting events (DLEs) from drug administration until Day 8 (7 days after treatment).
Multiple Dosing (MD) Part - the Number of Patients With Drug-related Adverse Events (AEs) From Drug Administration Until End of Trial.
Time frame: From drug administration (day 1) till End of Trial, up to 23 weeks.
Multiple dosing (MD) part - the number of patients with drug-related Adverse Events (AEs) from drug administration until End of Trial.
17 secondary outcomes
SRD Part - Number of Patients With Drug-related Adverse Events at End of Trial
Time frame: From drug administration (day 1) till End of Trial, up to 15 weeks.
SRD Part - Number of Patients With Ocular Adverse Events (Eye Disorders) at End of Trial
Time frame: From drug administration (day 1) till End of Trial, up to 15 weeks.
MD Part - Number of Patients With Ocular Adverse Events (Eye Disorders) at End of Trial
Time frame: From drug administration (day 1) till End of Trial, up to 23 weeks.
MD Part - Change From Baseline of the Size of the FAZ in FTR at Visit 5
Time frame: Baseline (day 0) and Visit 5 (day 85±7).
MD Part - Change From Baseline of the Size of the FAZ in SVC at Visit 5
Time frame: Baseline (day 0) and Visit 5 (day 85±7).
MD Part - Change From Baseline of the Size of the FAZ in FTR at Visit 7
Time frame: Baseline (day 0) and Visit 7 (day 155±7).
MD Part - Change From Baseline of the Size of the FAZ in SVC at Visit 7
Time frame: Baseline (day 0) and Visit 7 (day 155±7).
MD Part - Change From Baseline of Best Corrected Visual Acuity (BCVA) at Visit 3
Time frame: Baseline (day 0) and Visit 3 (day 29±7).
MD Part - Change From Baseline of Best Corrected Visual Acuity (BCVA) at Visit 4
Time frame: Baseline (day 0) and Visit 4 (day 57±7).
MD Part - Change From Baseline of Best Corrected Visual Acuity (BCVA) at Visit 5
Time frame: Baseline (day 0) and Visit 5 (day 85±7).
MD Part - Change From Baseline of Best Corrected Visual Acuity (BCVA) at Visit 6
Time frame: Baseline (day 0) and Visit 6 (day 113±7).
MD Part - Change From Baseline of Best Corrected Visual Acuity (BCVA) at Visit 7
Time frame: Baseline (day 0) and Visit 7 (day 155±7).
MD Part - Change From Baseline of Central Retinal Thickness (CRT) at Visit 3
Time frame: Baseline (day 0) and Visit 3 (day 29±7).
MD Part - Change From Baseline of Central Retinal Thickness (CRT) at Visit 4
Time frame: Baseline (day 0) and Visit 4 (day 57±7)
MD Part - Change From Baseline of Central Retinal Thickness (CRT) at Visit 5
Time frame: Baseline (day 0) and Visit 5 (day 85±7).
MD Part - Change From Baseline of Central Retinal Thickness (CRT) at Visit 6
Time frame: Baseline (day 0) and Visit 6 (day 113±7).
MD Part - Change From Baseline of Central Retinal Thickness (CRT) at Visit 7
Time frame: Baseline (day 0) and Visit 7 (day 155±7).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35978329Chong V, Nguyen QD, Sepah Y, Giani A, Pearce E. HORNBILL: a phase I/IIa trial examining the safety, tolerability and early response of BI 764524 in patients with diabetic retinopathy and diabetic macular ischaemia-rationale, study design and protocol. Trials. 2022 Aug 17;23(1):669. doi: 10.1186/s13063-022-06527-y.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BI 764524 in people with Diabetic Retinopathy, run by Boehringer Ingelheim at 19 sites in 2 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 15 inclusion and 18 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 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, United Kingdom. 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. Some participants in this study may receive a placebo. 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 22 May 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?
Single-rising Dose (SRD) Part - The Number of Patients With Dose Limiting Events (DLEs) From Drug Administration Until Day 8 (time frame: From drug administration (day 1) till day 8, Up to 7±2 days.). 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 NCT04424290, which also lists 1 linked publication.
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 22 May 2024.