A Study to Test How Well Different Doses of BI 771716 Are Tolerated by People With an Advanced Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy
Study Details
Study Description
Brief Summary
This study is open to adults with geographic atrophy, an advanced form of age-related macular degeneration. People can join the study if they are at least 50 years old. The purpose of this study is to find out how well different doses of a medicine called BI 771716 are tolerated.
This study has 2 parts. Part 1 of the study takes about 3 months. In this part, participants receive 1 injection of BI 771716 directly into one of the eyes affected by geographic atrophy.
Part 2 of the study takes about 4 months. In this part, participants receive 2 injections of BI 771716 directly into the eye. There are 4 weeks between the first and the second injection. In this study, BI 771716 is given to humans for the first time.
The doctors compare how well participants tolerate the different doses of BI 771716. 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 771716 low dose treatment group (Single rising dose (SRD part))
|
Drug: BI 771716
BI 771716
|
| Experimental: BI 771716 treatment group (multiple dose (MD part))
|
Drug: BI 771716
BI 771716
|
| Experimental: BI 771716 medium dose treatment group (SRD part)
|
Drug: BI 771716
BI 771716
|
| Experimental: BI 771716 high dose treatment group (SRD part)
|
Drug: BI 771716
BI 771716
|
Outcome Measures
Primary Outcome Measures
- Occurrence of ocular dose limiting events (DLEs) from drug administration until Day 8 [Up to 7 days]
SRD part
- Occurrence of drug-related adverse events (AEs) from drug administration until end of study (EOS) [Up to 112 days]
MD part
Secondary Outcome Measures
- Occurrence of any ocular adverse events (AEs) in the study eye from drug administration until EOS [Up to 112 days]
SRD part
- Maximum serum concentration of BI 771716 after a single intravitreal (IVT) dose (Cmax) [Up to 84 days]
SRD part
- Area under the concentration-time curve of BI 771716 in serum over the time interval from 0 extrapolated to infinity (AUC0-∞) [Up to 84 days]
SRD part
- Time from dosing to maximum serum concentration of BI 771716 (tmax) [Up to 84 days]
SRD part
- Trough concentration of BI 771716 in serum [At Day 29]
MD part
- BI 771716 serum concentration [At Day 57]
MD part
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Men and women with geographic atrophy (GA) secondary to age-related macular degeneration (AMD), with any GA lesion of minimum 1 disc diameter in size, and unlimited maximum size. This may include GA lesions contiguous to or continuous with peripapillary atrophy.
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Fellow eye is not required to have GA.
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Best corrected visual acuity (BCVA) in the non-study eye must have a better BCVA compared to the study eye.
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BCVA of ≥4 and ≤70 letters in the study eye (approximate equivalent to 20/800 and 20/40 on the Snellen chart) measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol.
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Age at least 50 years.
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Men able to father a child must be ready and able to use highly effective methods of birth control per the International Council on Harmonisation of Technical Requirements for Registration of Human Use guideline M3(R2) (ICH M3(R2)) that would result in a low failure rate of less than 1% per year when used consistently and correctly.
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Signed informed consent consistent with ICH good clinical practice (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:
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Women of childbearing potential (WOCBP) cannot be included. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy or another cause as determined by the investigator (e.g. Müllerian agenesis). Tubal ligation is NOT a method of permanent sterilization. A postmenopausal state is defined as no menses for 1 year without an alternative medical cause.
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History of or evidence of current active exudative choroidal neovascularization (CNV) in the study eye. History of evidence of exudative CNV in the fellow eye is not exclusionary. Eyes with evidence of non-exudative CNV are not exclusionary (as identified by Optical coherence tomography angiography (OCT-A) or Indocyanine green angiography (ICG-A)).
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Previously received treatment in the study eye for GA secondary to AMD within 3 months prior to screening.
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Previous trial participation receiving trial medication for GA in the study eye secondary to AMD within 6 months prior to screening. Use of any investigational drug within 90 days or 5 half-lives prior to screening, whichever is longer.
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Previously received gene therapy or cell therapy.
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Additional eye disease in the study eye that could compromise trial participation:
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uncontrolled glaucoma or intraocular pressure >24 mmHg.
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clinically significant diabetic maculopathy.
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history of high myopia >8 diopters in the study eye.
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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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exclude ocular conditions at discretion of BI that might interfere with outcome of the trial.
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Exclude prior vitrectomy surgery.
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Exclude study eyes that have undergone glaucoma drainage implantation or trabeculectomy. History of microinvasive glaucoma surgery may be included.
Further exclusion criteria apply.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 1497-0001