Macular DegenerationPhase 1NCT04002310
A Study to Test How Well Different Doses of BI 754132 Are Tolerated in Patients With an Advanced Form of Age-related Macular Degeneration Called Geographic Atrophy
A Phase 1 study testing BI 754132 in people with Macular Degeneration, run by Boehringer Ingelheim at 13 sites in 2 countries.
Trial summary
This is a study in adults with geographic atrophy, an advanced form of age-related macular degeneration. The purpose of this study is to find out how well different doses of BI 754132 are tolerated. The participants are in the study for about 4 months. During this time, they visit the study site about 10 times. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- BI 754132
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 26 Jul 2019to 9 Aug 2022
- Phase
- Phase 1
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD): For the SRD part, the GA lesion in the study eye must be ≥ 1.9 mm2 disc area in size (approximately ≥ 0.75 disc area in size); For the MD part the total GA lesion size in the study eye must be ≥ 7.5 mm2 (approximately ≥ 3 disc area in size)
- Fellow eye is not required to have GA
- Best Corrected Visual Acuity (BCVA):
- SRD part: BCVA of 20/100 to 20/400 Snellen (corresponding to 19 to 53 letters in the ETDRS chart) in the study eye equivalent measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol
- MD part: BCVA score of ≤53 letters (Snellen equivalent of 20/100) in the study eye
- Age ≥ than 50 years
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- Best-corrected VA in the non-study eye must have a better best-corrected VA compared to the study-eye
- 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 International Council on Harmonisation (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.
- Signed informed consent consistent with International Council on Harmonisation Good Clinical Practice (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
Who cannot join
- GA in either eye because of causes other than AMD
- History of choroidal neovascularization (CNV) in the study eye and in the fellow eye
- Previous treatment in the study eye for GA secondary to AMD within 6 months prior to screening visit (ongoing therapy with vitamin and mineral supplements is allowed)
- Additional eye disease in the study eye that could compromise
- best corrected VA (BCVA) with visual field loss,
- uncontrolled glaucoma intraocular pressure (IOP>24),
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- clinically significant diabetic maculopathy,
- history of ischemic optic neuropathy or retinal vascular occlusion,
- symptomatic vitreomacular traction,
- genetic disorders such as retinitis pigmentosa);
- history of high myopia > 8 diopters in the study eye and
- 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. desferoximine, chloroquine/hydrochloroquine, chlorpromazine, phenothiazines, tamoxifen, nicotinic acid, and ethambutol)
- 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, e.g. cardiac (including tachycardia), gastro-intestinal, hepatic, renal, metabolic, dermatologic, neurological, haematological, oncological and psychiatric.
- Patients with malignancy for which the patient has undergone resection, radiation or chemotherapy within past 5 years. Patients with treated basal cell carcinoma or fully cured squamous cell carcinoma are allowed.
- Known hypersensitivity to any of the ingredients used in the Investigational Medical Product (IMP) formulation, or any of the medications used
- Active intraocular inflammation in the study eye
- Active infectious conjunctivitis in either eye
- Further exclusion criteria apply
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States8 sites
Western Carolina Retinal Associate PA
Asheville, North Carolina, 28803
Southeast Retina Center, PC
Augusta, Georgia, 30909
Retina Consultants of Texas
Bellaire, Texas, 77401
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
Retina Foundation of the Southwest
Dallas, Texas, 75231
Retina Specialty Institute
Pensacola, Florida, 32503
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107
Center for Retina and Macular Disease
Winter Haven, Florida, 33880
United Kingdom5 sites
Bristol Eye Hospital
Bristol, BS1 2LX
Royal Liverpool University Hospital
Liverpool, L69 3GA
Moorfields Eye Hospital
London, EC1V 2PD
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
Southampton General Hospital
Southampton, SO16 6YD
About this study
Official title: Safety, Tolerability and Pharmacokinetics of Single Rising Intravitreal Doses and Multiple Intravitreal Dosing of BI 754132 in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration (Open Label, Non-randomized, Uncontrolled).
This is a study in adults with geographic atrophy, an advanced form of age-related macular degeneration. The purpose of this study is to find out how well different doses of BI 754132 are tolerated.
The participants are in the study for about 4 months. During this time, they visit the study site about 10 times. Participants receive 1 injection of BI 754132 directly into one of the eyes affected by geographic atrophy. In this study, BI 754132 is given to humans for the first time.
The doctors compare how well participants tolerate the different doses of BI 754132. The doctors also regularly check the general health of the participants.
- Conditions
- Macular Degeneration
- Being tested
- BI 754132
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 754132Drug
One single injection
| Study group | Role | What they receive |
|---|---|---|
| 0.3 mg BI 754132 - SRD part | Experimental | 0.3 milligram (mg) BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. Single rising dose (SRD) part. Receives: Drug: BI 754132 |
| 1 mg BI 754132 - SRD part | Experimental | 1 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part. Receives: Drug: BI 754132 |
| 3 mg BI 754132 - SRD part | Experimental | 3 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part. Receives: Drug: BI 754132 |
| 6 mg BI 754132 - SRD part | Experimental | 6 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part. Receives: Drug: BI 754132 |
| 6 mg BI 754132 - MD part | Experimental | 6 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as 3 injections, each separated by 4 weeks (that is, Day 1, Day 29 and Day 57). Multiple dose. Receives: Drug: BI 754132 |
What is being measured
The primary outcome is the main question the study is designed to answer.
SRD Part: Number of Patients With Ocular (in the Study Eye) or Systemic Dose Limiting Events (DLEs)
SRD part: Number of patients with ocular or systemic DLEs from drug administration. Systemic DLEs were defined as drug-related adverse events (AEs), as defined by the investigator, of moderate or severe intensity on the Common terminology criteria for adverse events (CTCAE) scale, and included diarrhea, cough, or patient-reported paraesthesia, dysgeusia, taste abnormality, taste disorder, or hyposmia. Single rising dose (SRD) part.
Measured: From drug administration until end of trial, up to 100 days.
MD Part: Number of Patients With Drug Related Adverse Events (AEs)
Number of patients with drug-related adverse events (AEs). Multiple dose (MD) part.
Measured: From drug administration until end of trial, up to 155 days
Secondary outcomes (8)
SRD Part: Number of Patients With Drug-related Adverse Events (AEs)
Number of patients with drug-related AEs. Single rising dose (SRD) part.
Measured: From drug administration until end of trial, up to 100 days.
SRD Part: Number of Patients With Any Ocular Adverse Events (AEs) in the Study Eye
Number of patients with any ocular adverse events in the study eye. Single rising dose (SRD) part.
Measured: From drug administration until end of trial, up to 100 days.
SRD Part: Maximum Serum Concentration of BI 754132 After a Single Intravitreal Dose (Cmax)
Maximum serum concentration of BI 754132 after a single intravitreal dose (Cmax). Single rising dose (SRD) part.
Measured: At Day 1, 4, 8, 15, 29, 56, 84 and Day 100.
SRD Part: Area Under the Concentration-time Curve of BI 754132 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of BI 754132 in serum over the time interval from 0 extrapolated to infinity (AUC0-∞). Singe rising dose (SRD) part.
Measured: At Day 1, 4, 8, 15, 29, 56, 84 and Day 100.
SRD Part: Time From Dosing to Maximum Serum Concentration of BI 754132 (Tmax)
Time from dosing to maximum serum concentration of BI 754132 (tmax). Single rising dose (SRD part).
Measured: At Day 1, 4, 8, 15, 29, 56, 84 and Day 100.
MD Part: Trough Levels of BI 754132 Before Second Administration (Cmin,1)
Systematic exposure of BI 754132 after multiple intravitreal doses as assessed by Cmin,1 (trough levels of BI 754132 before second administration). Multiple dose (MD) part.
Measured: Up to 29 days.
MD Part: Trough Levels of BI 754132 Before Third Administration (Cmin,2)
Systematic exposure of BI 754132 after multiple intravitreal doses as assessed by Cmin,2 (trough levels of BI 754132 before third administration). Multiple dose (MD) part.
Measured: Up to 57 days.
MD Part: Plasma Concentration of BI 754132 4, 8 and 14 Weeks After the Third Administration
Plasma concentration of BI 754132 4, 8 and 14 weeks after the third administration. Multiple dose (MD) part.
Measured: At Day 85, 113 and Day 155.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start26 Jul 2019
- Primary completion9 Aug 2022
- Study completion9 Aug 2022
Why it stopped: The trial was discontinued in the interests of patients considering benefit/risk balance.
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.
- Other trials for Macular DegenerationStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT04002310
- Sponsor's protocol ID
- 1418-0001
- Other IDs
- 2018-004125-92, 2018
- Status last verified
- Sep 2023
- First submitted
- 27 Jun 2019
- Last updated
- 15 Sep 2023
- 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Pharmacokinetics of Single Rising Intravitreal Doses and Multiple Intravitreal Dosing of BI 754132 in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration (Open Label, Non-randomized, Uncontrolled).
- ClinicalTrials.gov ID
- NCT04002310
- Acronym / sponsor ID
- 1418-0001
- Conditions
- Macular Degeneration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was discontinued in the interests of patients considering benefit/risk balance.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 26 Jul 2019 (actual)
- Primary completion
- 9 Aug 2022 (actual)
- Study completion
- 9 Aug 2022 (actual)
- First posted
- 28 Jun 2019 (actual)
- Results
- Posted 15 Sep 2023
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 adults with geographic atrophy, an advanced form of age-related macular degeneration. The purpose of this study is to find out how well different doses of BI 754132 are tolerated.
The participants are in the study for about 4 months. During this time, they visit the study site about 10 times. Participants receive 1 injection of BI 754132 directly into one of the eyes affected by geographic atrophy. In this study, BI 754132 is given to humans for the first time.
The doctors compare how well participants tolerate the different doses of BI 754132. The doctors also regularly check the general health of the participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 0.3 mg BI 754132 - SRD part | Experimental | Drug: BI 7541320.3 milligram (mg) BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. Single rising dose (SRD) part. |
| 1 mg BI 754132 - SRD part | Experimental | Drug: BI 7541321 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part. |
| 3 mg BI 754132 - SRD part | Experimental | Drug: BI 7541323 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part. |
| 6 mg BI 754132 - SRD part | Experimental | Drug: BI 7541326 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as one single injection on Day 1. One patient was dosed first, and when the safety assessments through Day 4 showed no ophthalmological dose limiting events (DLEs) or systemic DLEs, the remaining patients were dosed. SRD part. |
| 6 mg BI 754132 - MD part | Experimental | Drug: BI 7541326 mg BI 754132 powder for solution for injection 60mg/vial with solution of diluent was administered intravitreally as 3 injections, each separated by 4 weeks (that is, Day 1, Day 29 and Day 57). Multiple dose. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men and women with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD): For the SRD part, the GA lesion in the study eye must be ≥ 1.9 mm2 disc area in size (approximately ≥ 0.75 disc area in size); For the MD part the total GA lesion size in the study eye must be ≥ 7.5 mm2 (approximately ≥ 3 disc area in size)
- Fellow eye is not required to have GA
- Best Corrected Visual Acuity (BCVA):
- Age ≥ than 50 years
- Best-corrected VA in the non-study eye must have a better best-corrected VA compared to the study-eye
Key exclusion criteria (24 listed)
- GA in either eye because of causes other than AMD
- History of choroidal neovascularization (CNV) in the study eye and in the fellow eye
- Previous treatment in the study eye for GA secondary to AMD within 6 months prior to screening visit (ongoing therapy with vitamin and mineral supplements is allowed)
- Additional eye disease in the study eye that could compromise
- Any prior intraocular surgery in the study eye other then uneventful lens replacement for cataract 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 754132One single injection | Drug | 0.3 mg BI 754132 - SRD part, 1 mg BI 754132 - SRD part, 3 mg BI 754132 - SRD part, 6 mg BI 754132 - MD part, 6 mg BI 754132 - SRD part |
Primary outcome
SRD Part: Number of Patients With Ocular (in the Study Eye) or Systemic Dose Limiting Events (DLEs)
Time frame: From drug administration until end of trial, up to 100 days.
SRD part: Number of patients with ocular or systemic DLEs from drug administration. Systemic DLEs were defined as drug-related adverse events (AEs), as defined by the investigator, of moderate or severe intensity on the Common terminology criteria for adverse events (CTCAE) scale, and included diarrhea, cough, or patient-reported paraesthesia, dysgeusia, taste abnormality, taste disorder, or hyposmia. Single rising dose (SRD) part.
MD Part: Number of Patients With Drug Related Adverse Events (AEs)
Time frame: From drug administration until end of trial, up to 155 days
Number of patients with drug-related adverse events (AEs). Multiple dose (MD) part.
8 secondary outcomes
SRD Part: Number of Patients With Drug-related Adverse Events (AEs)
Time frame: From drug administration until end of trial, up to 100 days.
SRD Part: Number of Patients With Any Ocular Adverse Events (AEs) in the Study Eye
Time frame: From drug administration until end of trial, up to 100 days.
SRD Part: Maximum Serum Concentration of BI 754132 After a Single Intravitreal Dose (Cmax)
Time frame: At Day 1, 4, 8, 15, 29, 56, 84 and Day 100.
SRD Part: Area Under the Concentration-time Curve of BI 754132 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: At Day 1, 4, 8, 15, 29, 56, 84 and Day 100.
SRD Part: Time From Dosing to Maximum Serum Concentration of BI 754132 (Tmax)
Time frame: At Day 1, 4, 8, 15, 29, 56, 84 and Day 100.
MD Part: Trough Levels of BI 754132 Before Second Administration (Cmin,1)
Time frame: Up to 29 days.
MD Part: Trough Levels of BI 754132 Before Third Administration (Cmin,2)
Time frame: Up to 57 days.
MD Part: Plasma Concentration of BI 754132 4, 8 and 14 Weeks After the Third Administration
Time frame: At Day 85, 113 and Day 155.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 754132 in people with Macular Degeneration, run by Boehringer Ingelheim at 13 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 10 inclusion and 24 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: stopped early, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 15 Sep 2023). 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 Patients With Ocular (in the Study Eye) or Systemic Dose Limiting Events (DLEs) (time frame: From drug administration until end of trial, up to 100 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?
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 15 Sep 2023.