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NCT06006585CompletedPhase 1

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

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)

Source: ClinicalTrials.gov · Last updated 18 Feb 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
20 (actual)
First submitted
17 Aug 2023
Start date
6 Oct 2023
Primary completion date
24 May 2024
Lead sponsor
Boehringer Ingelheim
NCT number
NCT06006585

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 20
  • From 6 Oct 2023 to the primary completion date, 24 May 2024
  • 9 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • Exclude prior vitrectomy surgery.

Other illness

  • 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)) .
  • 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 study eyes that have undergone glaucoma drainage implantation or trabeculectomy. History of microinvasive glaucoma surgery may be included.
    • Further exclusion criteria apply.

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Austin Clinical Research, LLC
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status
Erie Retina Research LLC
Coordinator of this site? Confirm its status
ErieUnited StatesUnknown status
Verum Research, LLC
Coordinator of this site? Confirm its status
EugeneUnited StatesUnknown status
Retina Consultants of Houston, PA-Houston-62050
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Florida Retina Institute
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesUnknown status
Florida Eye Associates
Coordinator of this site? Confirm its status
MelbourneUnited StatesUnknown status
Tennessee Retina
Coordinator of this site? Confirm its status
NashvilleUnited StatesUnknown status
Retina Consultants of Texas-The Woodlands-67575
Coordinator of this site? Confirm its status
The WoodlandsUnited StatesUnknown status
Bay Area Retina Associates - Walnut Creek
Coordinator of this site? Confirm its status
Walnut CreekUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.