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Geographic AtrophyPhase 1NCT06006585

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

A Phase 1 study testing BI 771716 in people with Geographic Atrophy, run by Boehringer Ingelheim at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Geographic Atrophy
What is being tested?
BI 771716
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
9 sitesUnited States
Study dates
6 Oct 2023to 24 May 2024
Phase
Phase 1
Are there results?
None posted in the registry

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), 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.

Who cannot join

  • 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:
Show all 14Show fewer
  • 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.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Austin Clinical Research, LLC

    Austin, Texas, 78750

  • Erie Retina Research, LLC

    Erie, Pennsylvania, 16507

  • Verum Research, LLC

    Eugene, Oregon, 97401

  • Retina Consultants of Houston, PA-Houston-62050

    Houston, Texas, 77030

  • Florida Retina Institute

    Jacksonville, Florida, 32204

  • Florida Eye Associates

    Melbourne, Florida, 32901

  • Tennessee Retina

    Nashville, Tennessee, 37215

  • Retina Consultants of Texas-The Woodlands-67575

    The Woodlands, Texas, 77384

  • Bay Area Retina Associates - Walnut Creek

    Walnut Creek, California, 94598

Other trials in United States

About this study

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)

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.

Read more

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.

Being tested
BI 771716
Medical subject headings
Geographic Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BI 771716Drug

    BI 771716

Study groups in NCT06006585
Study groupRoleWhat they receive
BI 771716 low dose treatment group (Single rising dose (SRD part))ExperimentalNot described
Receives: Drug: BI 771716
BI 771716 treatment group (multiple dose (MD part))ExperimentalNot described
Receives: Drug: BI 771716
BI 771716 medium dose treatment group (SRD part)ExperimentalNot described
Receives: Drug: BI 771716
BI 771716 high dose treatment group (SRD part)ExperimentalNot described
Receives: Drug: BI 771716

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of ocular dose limiting events (DLEs) from drug administration until Day 8

    SRD part

    Measured: Up to 7 days

  2. Occurrence of drug-related adverse events (AEs) from drug administration until end of study (EOS)

    MD part

    Measured: Up to 112 days

Secondary outcomes (6)

  1. Occurrence of any ocular adverse events (AEs) in the study eye from drug administration until EOS

    SRD part

    Measured: Up to 112 days

  2. Maximum serum concentration of BI 771716 after a single intravitreal (IVT) dose (Cmax)

    SRD part

    Measured: Up to 84 days

  3. Area under the concentration-time curve of BI 771716 in serum over the time interval from 0 extrapolated to infinity (AUC0-∞)

    SRD part

    Measured: Up to 84 days

  4. Time from dosing to maximum serum concentration of BI 771716 (tmax)

    SRD part

    Measured: Up to 84 days

  5. Trough concentration of BI 771716 in serum

    MD part

    Measured: At Day 29

  6. BI 771716 serum concentration

    MD part

    Measured: At Day 57

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2023
  2. Study start6 Oct 2023
  3. Primary completion24 May 2024
  4. Study completion24 May 2024

Resources

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
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06006585
Sponsor's protocol ID
1497-0001
Status last verified
Feb 2025
First submitted
17 Aug 2023
Last updated
18 Feb 2025
Results posted
No
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. 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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 771716 in people with Geographic Atrophy, run by Boehringer Ingelheim at 9 sites in United States.

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 8 inclusion and 14 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: finished, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Occurrence of ocular dose limiting events (DLEs) from drug administration until Day 8 (time frame: Up to 7 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?

On the ClinicalTrials.gov record for NCT06006585.

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 18 Feb 2025.

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