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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

Primary Purpose

Geographic Atrophy

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BI 771716
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Geographic Atrophy

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 (minimum 2.5 mm^2) in size, and unlimited maximum size. This may include GA lesions contiguous to or continuous with peripapillary atrophy. Fellow eye is not required to have GA. Best corrected visual acuity (BCVA) in the non-study eye must have a better BCVA compared to the study eye. 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. Age at least 50 years. 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. 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. Not under any administrative or legal supervision or under institutionalization due to regulatory or juridical order. Exclusion Criteria: 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. 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 spectral domain optical coherence tomography (SD-OCT) and fluorescein angiography (FA)) . Previously received treatment in the study eye for GA secondary to AMD within 3 months prior to screening. 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. Previously received gene therapy or cell therapy. Additional eye disease in the study eye that could compromise trial participation: uncontrolled glaucoma or intraocular pressure >24 mmHg. clinically significant diabetic maculopathy. 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 Spectral domain optical coherence tomography (SD-OCT). exclude ocular conditions at discretion of the investigator that might interfere with outcome of the trial. Exclude prior vitrectomy surgery. Exclude study eyes that have undergone glaucoma drainage implantation or trabeculectomy. History of microinvasive glaucoma surgery may be included. Further exclusion criteria apply.

Sites / Locations

  • Bay Area Retina Associates - Walnut CreekRecruiting
  • Florida Retina InstituteRecruiting
  • Florida Eye AssociatesRecruiting
  • Retina Associates, LLCRecruiting
  • Verum Research, LLCRecruiting
  • Erie Retina Research, LLCRecruiting
  • Austin Clinical Research, LLCRecruiting
  • Retina Consultants of Houston, PARecruiting
  • Retina Consultants of TexasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

BI 771716 low dose treatment group (Single rising dose (SRD part))

BI 771716 treatment group (multiple dose (MD part))

BI 771716 medium dose treatment group (SRD part)

BI 771716 high dose treatment group (SRD part)

Arm Description

Outcomes

Primary Outcome Measures

Occurrence of ocular dose limiting events (DLEs) from drug administration until Day 8
SRD part
Occurrence of drug-related adverse events (AEs) from drug administration until end of study (EOS)
MD part

Secondary Outcome Measures

Occurrence of any ocular adverse events (AEs) in the study eye from drug administration until EOS
SRD part
Maximum serum concentration of BI 771716 after a single intravitreal (IVT) dose (Cmax)
SRD part
Area under the concentration-time curve of BI 771716 in serum over the time interval from 0 extrapolated to infinity (AUC0-∞)
SRD part
Time from dosing to maximum serum concentration of BI 771716 (tmax)
SRD part
Trough concentration of BI 771716 in serum
MD part
BI 771716 serum concentration
MD part

Full Information

First Posted
August 17, 2023
Last Updated
October 24, 2023
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT06006585
Brief Title
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
Official Title
Safety, Tolerability, and Pharmacokinetics of Intravitreal Single Rising Doses and Multiple Doses of BI 771716 in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration (Open Label, Non-randomized)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2023 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geographic Atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BI 771716 low dose treatment group (Single rising dose (SRD part))
Arm Type
Experimental
Arm Title
BI 771716 treatment group (multiple dose (MD part))
Arm Type
Experimental
Arm Title
BI 771716 medium dose treatment group (SRD part)
Arm Type
Experimental
Arm Title
BI 771716 high dose treatment group (SRD part)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BI 771716
Intervention Description
BI 771716
Primary Outcome Measure Information:
Title
Occurrence of ocular dose limiting events (DLEs) from drug administration until Day 8
Description
SRD part
Time Frame
Up to 7 days
Title
Occurrence of drug-related adverse events (AEs) from drug administration until end of study (EOS)
Description
MD part
Time Frame
Up to 112 days
Secondary Outcome Measure Information:
Title
Occurrence of any ocular adverse events (AEs) in the study eye from drug administration until EOS
Description
SRD part
Time Frame
Up to 112 days
Title
Maximum serum concentration of BI 771716 after a single intravitreal (IVT) dose (Cmax)
Description
SRD part
Time Frame
Up to 84 days
Title
Area under the concentration-time curve of BI 771716 in serum over the time interval from 0 extrapolated to infinity (AUC0-∞)
Description
SRD part
Time Frame
Up to 84 days
Title
Time from dosing to maximum serum concentration of BI 771716 (tmax)
Description
SRD part
Time Frame
Up to 84 days
Title
Trough concentration of BI 771716 in serum
Description
MD part
Time Frame
At Day 29
Title
BI 771716 serum concentration
Description
MD part
Time Frame
At Day 57

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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 (minimum 2.5 mm^2) in size, and unlimited maximum size. This may include GA lesions contiguous to or continuous with peripapillary atrophy. Fellow eye is not required to have GA. Best corrected visual acuity (BCVA) in the non-study eye must have a better BCVA compared to the study eye. 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. Age at least 50 years. 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. 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. Not under any administrative or legal supervision or under institutionalization due to regulatory or juridical order. Exclusion Criteria: 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. 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 spectral domain optical coherence tomography (SD-OCT) and fluorescein angiography (FA)) . Previously received treatment in the study eye for GA secondary to AMD within 3 months prior to screening. 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. Previously received gene therapy or cell therapy. Additional eye disease in the study eye that could compromise trial participation: uncontrolled glaucoma or intraocular pressure >24 mmHg. clinically significant diabetic maculopathy. 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 Spectral domain optical coherence tomography (SD-OCT). exclude ocular conditions at discretion of the investigator that might interfere with outcome of the trial. Exclude prior vitrectomy surgery. Exclude study eyes that have undergone glaucoma drainage implantation or trabeculectomy. History of microinvasive glaucoma surgery may be included. Further exclusion criteria apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Boehringer Ingelheim
Phone
1-800-243-0127
Email
clintriage.rdg@boehringer-ingelheim.com
Facility Information:
Facility Name
Bay Area Retina Associates - Walnut Creek
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Florida Retina Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Florida Eye Associates
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Retina Associates, LLC
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Verum Research, LLC
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Erie Retina Research, LLC
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Austin Clinical Research, LLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78750
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Retina Consultants of Houston, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Retina Consultants of Texas
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Links:
URL
http://www.mystudywindow.com
Description
Related Info

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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

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