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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06006585
Recruitment Status : Active, not recruiting
First Posted : August 23, 2023
Last Update Posted : April 30, 2024
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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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
Geographic Atrophy Drug: BI 771716 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : September 12, 2023
Estimated Primary Completion Date : May 24, 2024
Estimated Study Completion Date : May 24, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Occurrence of ocular dose limiting events (DLEs) from drug administration until Day 8 [ Time Frame: Up to 7 days ]
    SRD part

  2. Occurrence of drug-related adverse events (AEs) from drug administration until end of study (EOS) [ Time Frame: Up to 112 days ]
    MD part


Secondary Outcome Measures :
  1. Occurrence of any ocular adverse events (AEs) in the study eye from drug administration until EOS [ Time Frame: Up to 112 days ]
    SRD part

  2. Maximum serum concentration of BI 771716 after a single intravitreal (IVT) dose (Cmax) [ Time Frame: Up to 84 days ]
    SRD part

  3. Area under the concentration-time curve of BI 771716 in serum over the time interval from 0 extrapolated to infinity (AUC0-∞) [ Time Frame: Up to 84 days ]
    SRD part

  4. Time from dosing to maximum serum concentration of BI 771716 (tmax) [ Time Frame: Up to 84 days ]
    SRD part

  5. Trough concentration of BI 771716 in serum [ Time Frame: At Day 29 ]
    MD part

  6. BI 771716 serum concentration [ Time Frame: At Day 57 ]
    MD part


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Fellow eye is not required to have GA.
  3. Best corrected visual acuity (BCVA) in the non-study eye must have a better BCVA compared to the study eye.
  4. 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.
  5. Age at least 50 years.
  6. 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.
  7. 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.
  8. Not under any administrative or legal supervision or under institutionalization due to regulatory or juridical order.

Exclusion Criteria:

  1. 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.
  2. 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)) .
  3. Previously received treatment in the study eye for GA secondary to AMD within 3 months prior to screening.
  4. 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.
  5. Previously received gene therapy or cell therapy.

  6. Additional eye disease in the study eye that could compromise trial participation:

    1. uncontrolled glaucoma or intraocular pressure >24 mmHg.
    2. clinically significant diabetic maculopathy.
    3. history of high myopia >8 diopters in the study eye.
    4. anterior segment and vitreous abnormalities in the study eye that would preclude adequate observation with Spectral domain optical coherence tomography (SD-OCT).
    5. exclude ocular conditions at discretion of the investigator that might interfere with outcome of the trial.
  7. Exclude prior vitrectomy surgery.
  8. 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06006585


Locations
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United States, California
Bay Area Retina Associates - Walnut Creek
Walnut Creek, California, United States, 94598
United States, Florida
Florida Retina Institute
Jacksonville, Florida, United States, 32204
Florida Eye Associates
Melbourne, Florida, United States, 32901
United States, Oregon
Verum Research, LLC
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Erie Retina Research, LLC
Erie, Pennsylvania, United States, 16507
United States, Tennessee
Tennessee Retina
Nashville, Tennessee, United States, 37215
United States, Texas
Austin Clinical Research, LLC
Austin, Texas, United States, 78750
Retina Consultants of Houston, PA
Houston, Texas, United States, 77030
Retina Consultants of Texas
The Woodlands, Texas, United States, 77384
Sponsors and Collaborators
Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT06006585    
Other Study ID Numbers: 1497-0001
First Posted: August 23, 2023    Key Record Dates
Last Update Posted: April 30, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Degeneration
Geographic Atrophy
Atrophy
Retinal Degeneration
 Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical