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

NCT06006585 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 1497-0001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 9

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.

Conditions

Geographic Atrophy

Outcome Measures

Primary Outcomes (2)

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

  SRD part

  Up to 7 days

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

  MD part

  Up to 112 days

Secondary Outcomes (6)

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

  Up to 112 days

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

  Up to 84 days

• 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

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

  Up to 84 days

• Trough concentration of BI 771716 in serum

  At Day 29

Study Arms (4)

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

EXPERIMENTAL

Drug: BI 771716

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

EXPERIMENTAL

Drug: BI 771716

BI 771716 medium dose treatment group (SRD part)

EXPERIMENTAL

Drug: BI 771716

BI 771716 high dose treatment group (SRD part)

EXPERIMENTAL

Drug: BI 771716

Interventions

BI 771716 DRUG

BI 771716

BI 771716 high dose treatment group (SRD part); BI 771716 low dose treatment group (Single rising dose (SRD part)); BI 771716 medium dose treatment group (SRD part); BI 771716 treatment group (multiple dose (MD part))

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (9)

Bay Area Retina Associates - Walnut Creek

Walnut Creek, California, 94598, United States

Location

Florida Retina Institute

Jacksonville, Florida, 32204, United States

Location

Florida Eye Associates

Melbourne, Florida, 32901, United States

Location

Verum Research, LLC

Eugene, Oregon, 97401, United States

Location

Erie Retina Research, LLC

Erie, Pennsylvania, 16507, United States

Location

Tennessee Retina

Nashville, Tennessee, 37215, United States

Location

Austin Clinical Research, LLC

Austin, Texas, 78750, United States

Location

Retina Consultants of Houston, PA-Houston-62050

Houston, Texas, 77030, United States

Location

Retina Consultants of Texas-The Woodlands-67575

The Woodlands, Texas, 77384, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Geographic Atrophy

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 23, 2023
• Study Start: October 6, 2023
• Primary Completion: May 24, 2024
• Study Completion: May 24, 2024
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)