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
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BI 754132 Single Rising Dose (SRD) part followed by a Multiple Dosing (MD) part |
Drug: BI 754132
One single injection
|
Outcome Measures
Primary Outcome Measures
- Single Rising Dose (SRD) part: Number of patients with ocular (in the study eye) and systemic dose limiting events (DLEs) from drug administration till end of trial (EOT) [Up to 100 days]
- Multiple Dosing (MD) part: Number of patients with drug related Adverse Events (AEs) from drug administration until EOT [Up to 155 days]
Secondary Outcome Measures
- SRD part: Number of patients with drug-related AEs from drug administration until EOT [Up to 100 days]
- SRD part: Number of patients with any ocular AEs in the study eye from drug administration until EOT [Up to 100 days]
- SRD part: Maximum serum concentration of BI 754132 after a single intravitreal dose (Cmax) [Up to 100 days]
- SRD part: Area under the concentration-time curve of BI 754132 in serum over the time interval from 0 extrapolated to infinity (AUC0-∞) [Up to 100 days]
- SRD part: Time from dosing to maximum serum concentration of BI 754132 (tmax) [Up to 100 days]
- MD part: Trough levels of BI 754132 before second administration (Cmin,1) [Up to 29 days]
- MD part: Trough levels of BI 754132 before third administration (Cmin,2) [Up to 57 days]
- MD part: Plasma concentration of BI 754132 4 weeks after the third administration [Up to 85 days]
- MD part: Plasma concentration of BI 754132 8 weeks after the third administration [Up to 113 days]
- MD part: Plasma concentration of BI 754132 14 weeks after the third administration [Up to 155 days]
Eligibility Criteria
Criteria
Inclusion criteria:
-
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
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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
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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.
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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
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Not under any administrative or legal supervision or under institutionalization due to regulatory or juridical order
Exclusion criteria
-
GA in either eye because of causes other than AMD
-
History of choroidal neovascularization (CNV) in the study eye and in the fellow eye
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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)
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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,
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symptomatic vitreomacular traction,
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genetic disorders such as retinitis pigmentosa);
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history of high myopia > 8 diopters in the study eye and
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anterior segment and vitreous abnormalities in the study eye that would preclude adequate observation with Spectral Domain Optical Coherence Tomography (SD-OCT)
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Any prior intraocular surgery in the study eye other then uneventful lens replacement for cataract within 3 months prior to screening
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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
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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)
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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:
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Put the patient at risk because of participation in the study
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Influence the results of the study,
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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.
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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.
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Known hypersensitivity to any of the ingredients used in the Investigational Medical Product (IMP) formulation, or any of the medications used
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Active intraocular inflammation in the study eye
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Active infectious conjunctivitis in either eye
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Further exclusion criteria apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Retina-Vitreous Associates Medical Group | Beverly Hills | California | United States | 90211 |
| 2 | Retina Specialty Institute | Pensacola | Florida | United States | 32503 |
| 3 | Center for Retina and Macular Disease | Winter Haven | Florida | United States | 33880 |
| 4 | Southeast Retina Center, PC | Augusta | Georgia | United States | 30909 |
| 5 | Western Carolina Retinal Associate PA | Asheville | North Carolina | United States | 28803 |
| 6 | Mid Atlantic Retina | Philadelphia | Pennsylvania | United States | 19107 |
| 7 | Retina Consultants of Texas | Bellaire | Texas | United States | 77401 |
| 8 | Retina Foundation of the Southwest | Dallas | Texas | United States | 75231 |
| 9 | Bristol Eye Hospital | Bristol | United Kingdom | BS1 2LX | |
| 10 | Royal Liverpool University Hospital | Liverpool | United Kingdom | L69 3GA | |
| 11 | Moorfields Eye Hospital | London | United Kingdom | EC1V 2PD | |
| 12 | Royal Victoria Infirmary | Newcastle upon Tyne | United Kingdom | NE1 4LP | |
| 13 | Southampton General Hospital | Southampton | United Kingdom | SO16 6YD |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 1418-0001
- 2018-004125-92