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A Study Assessing the Long-Term Safety and Tolerability of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Primary Purpose

Macular Degeneration, Age-Related, Geographic Atrophy

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Galegenimab
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration, Age-Related

Eligibility Criteria

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

Inclusion Criteria:

  • Completed the parent study (NCT03972709/GR40973) through the Week 76 visit without early treatment discontinuation
  • Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit acceptable fundus imaging.

Ocular Inclusion Criteria: Study Eye - If the study eye best corrected visual acuity (BCVA) letter score is ≥69 letters (Snellen equivalent of 20/40 or better), the non-study eye must have a BCVA letter score of ≥44 letters (Snellen equivalent of 20/125 or better) on visit Day 1 of the open label extension (OLE)/Week 76 of parent study.

Ocular Inclusion Criteria: Non-Study Eye

- The non-study eye must have a BCVA letter score of ≥44 letters (Snellen equivalent of 20/125 or better) if the study eye BCVA letter score is ≥69 letters (Snellen equivalent of 20/40 or better) on visit Day 1 OLE/Week 76 of parent study.

Exclusion Criteria:

Ocular Exclusion Criteria:

  • Active uveitis and/or vitritis (grade trace or above) in either eye
  • Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
  • Active or history of choroidal neovascularization (CNV) in study eye that requires anti-vascular endothelial growth factor (anti-VEGF) treatment
  • Active or recent history (i.e., since enrollment in parent study) of optic neuritis in either eye
  • Retinal pigment epithelium (RPE) tear that involves the macula in either eye
  • Moderate or severe non-proliferative diabetic retinopathy in either eye
  • Proliferative diabetic retinopathy in either eye
  • Central serous retinopathy in either eye
  • Recent history of recurrent infectious or inflammatory ocular disease in either eye
  • Recent history of idiopathic or autoimmune-associated uveitis in either eye
  • Any concurrent ocular or intraocular condition in the study eye that contraindicates the use of an investigational drug or may affect interpretation of the study results or may render the participant at high risk for treatment complications.

Sites / Locations

  • California Retina Consultants
  • The Retina Partners
  • Retina Consultants of Orange County
  • Northern California Retina Vitreous Associates
  • Retina Consultants, San Diego
  • Retinal Consultants Med Group
  • West Coast Retina
  • California Retina Consultants
  • California Retina Consultants - Santa Maria
  • Bay Area Retina Associates
  • Retina Consultants of Southern Colorado PC
  • Southwest Retina Consultants
  • Colorado Retina Associates, PC
  • Rand Eye
  • Florida Eye Associates - Melbourne 2nd Office
  • Retina Specialty Institute
  • Retina Vitreous Assoc of FL
  • Southern Vitreoretinal Associates
  • Southeast Retina Center
  • Georgia Retina PC
  • Illinois Eye and Ear Infirmary
  • Wolfe Eye Clinic
  • Vitreo Retinal Consultants
  • Johns Hopkins University
  • Vitreo-Retinal Associates
  • Associated Retinal Consultants PC
  • Midwest Vision Research Foundation
  • The Retina Institute
  • Sierra Eye Associates
  • NJ Retina Teaneck Clinic
  • NJ Retina-Toms River
  • Ophthalmic Consultants of Long Island
  • Western Carolina Retinal Associate PA
  • Charlotte Eye Ear Nose and Throat Associates PA
  • Cincinnati Eye Institute
  • Cleveland Clinic Foundation; Cole Eye Institute
  • Casey Eye Institute
  • Mid Atlantic Retina - Wills Eye Hospital
  • Palmetto Retina Center
  • Southeastern Retina Associates Chattanooga
  • Charles Retina Institute
  • Tennessee Retina PC
  • Austin Retina Associates
  • Austin Clinical Research LLC
  • Retina Foundation of the Southwest
  • Retina Consultants of Texas
  • Spokane Eye Clinical Research
  • University of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Galegenimab 20 mg Q4W

Galegenimab 20 mg Q8W

Galegenimab 10 mg Q4W

Galegenimab 10 mg Q8W

Arm Description

Participants will receive 20 milligrams (mg) galegenimab via ITV injection every 4 weeks (Q4W).

Participants will receive 20 mg galegenimab via ITV injection every 8 weeks (Q8W).

Participants will receive 10 mg galegenimab via ITV injection Q4W.

Participants will receive 10 mg galegenimab via ITV injection Q8W.

Outcomes

Primary Outcome Measures

Percentage of Participants With Ocular Adverse Events
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region.
Percentage of Participants With Systemic (Non-Ocular) Adverse Events
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test.

Secondary Outcome Measures

Full Information

First Posted
October 22, 2020
Last Updated
October 12, 2023
Sponsor
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04607148
Brief Title
A Study Assessing the Long-Term Safety and Tolerability of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Official Title
A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intravitreal Injections of FHTR2163 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
The benefit to risk balance did not support further treatment with galegenimab (FHTR2163).
Study Start Date
November 16, 2020 (Actual)
Primary Completion Date
November 14, 2022 (Actual)
Study Completion Date
November 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to evaluate the long-term safety and tolerability of intravitreal (ITV) injections of galegenimab (FHTR2163) administered every 4 weeks (Q4W) or every 8 weeks (Q8W) in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) who completed the parent study (NCT03972709/GR40973).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration, Age-Related, Geographic Atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
The study will be masked until database lock of the parent study (NCT03972709/GR40973). After the masked period, the study will follow an open-label design. The Outcome Assessor is masked for BCVA assessments.
Allocation
Non-Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Galegenimab 20 mg Q4W
Arm Type
Experimental
Arm Description
Participants will receive 20 milligrams (mg) galegenimab via ITV injection every 4 weeks (Q4W).
Arm Title
Galegenimab 20 mg Q8W
Arm Type
Experimental
Arm Description
Participants will receive 20 mg galegenimab via ITV injection every 8 weeks (Q8W).
Arm Title
Galegenimab 10 mg Q4W
Arm Type
Experimental
Arm Description
Participants will receive 10 mg galegenimab via ITV injection Q4W.
Arm Title
Galegenimab 10 mg Q8W
Arm Type
Experimental
Arm Description
Participants will receive 10 mg galegenimab via ITV injection Q8W.
Intervention Type
Drug
Intervention Name(s)
Galegenimab
Other Intervention Name(s)
FHTR2163
Intervention Description
Intravitreal (ITV) injections of galegenimab
Primary Outcome Measure Information:
Title
Percentage of Participants With Ocular Adverse Events
Description
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region.
Time Frame
From baseline up to Week 104
Title
Percentage of Participants With Systemic (Non-Ocular) Adverse Events
Description
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test.
Time Frame
From Baseline up to Week 104

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Completed the parent study (NCT03972709/GR40973) through the Week 76 visit without early treatment discontinuation Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit acceptable fundus imaging. Ocular Inclusion Criteria: Study Eye - If the study eye best corrected visual acuity (BCVA) letter score is ≥69 letters (Snellen equivalent of 20/40 or better), the non-study eye must have a BCVA letter score of ≥44 letters (Snellen equivalent of 20/125 or better) on visit Day 1 of the open label extension (OLE)/Week 76 of parent study. Ocular Inclusion Criteria: Non-Study Eye - The non-study eye must have a BCVA letter score of ≥44 letters (Snellen equivalent of 20/125 or better) if the study eye BCVA letter score is ≥69 letters (Snellen equivalent of 20/40 or better) on visit Day 1 OLE/Week 76 of parent study. Exclusion Criteria: Ocular Exclusion Criteria: Active uveitis and/or vitritis (grade trace or above) in either eye Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye Active or history of choroidal neovascularization (CNV) in study eye that requires anti-vascular endothelial growth factor (anti-VEGF) treatment Active or recent history (i.e., since enrollment in parent study) of optic neuritis in either eye Retinal pigment epithelium (RPE) tear that involves the macula in either eye Moderate or severe non-proliferative diabetic retinopathy in either eye Proliferative diabetic retinopathy in either eye Central serous retinopathy in either eye Recent history of recurrent infectious or inflammatory ocular disease in either eye Recent history of idiopathic or autoimmune-associated uveitis in either eye Any concurrent ocular or intraocular condition in the study eye that contraindicates the use of an investigational drug or may affect interpretation of the study results or may render the participant at high risk for treatment complications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
California Retina Consultants
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
The Retina Partners
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Retina Consultants of Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835-3424
Country
United States
Facility Name
Northern California Retina Vitreous Associates
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Retina Consultants, San Diego
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Retinal Consultants Med Group
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
West Coast Retina
City
San Francisco
State/Province
California
ZIP/Postal Code
94109-5520
Country
United States
Facility Name
California Retina Consultants
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93103
Country
United States
Facility Name
California Retina Consultants - Santa Maria
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Bay Area Retina Associates
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Retina Consultants of Southern Colorado PC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Southwest Retina Consultants
City
Durango
State/Province
Colorado
ZIP/Postal Code
81303
Country
United States
Facility Name
Colorado Retina Associates, PC
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Rand Eye
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Florida Eye Associates - Melbourne 2nd Office
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Retina Specialty Institute
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Retina Vitreous Assoc of FL
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33711
Country
United States
Facility Name
Southern Vitreoretinal Associates
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Southeast Retina Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Georgia Retina PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060-1137
Country
United States
Facility Name
Illinois Eye and Ear Infirmary
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Wolfe Eye Clinic
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Vitreo Retinal Consultants
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Vitreo-Retinal Associates
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Associated Retinal Consultants PC
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Midwest Vision Research Foundation
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
The Retina Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
NJ Retina Teaneck Clinic
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
NJ Retina-Toms River
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Ophthalmic Consultants of Long Island
City
Oceanside
State/Province
New York
ZIP/Postal Code
11572
Country
United States
Facility Name
Western Carolina Retinal Associate PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Charlotte Eye Ear Nose and Throat Associates PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Cleveland Clinic Foundation; Cole Eye Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195-0001
Country
United States
Facility Name
Casey Eye Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Mid Atlantic Retina - Wills Eye Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Palmetto Retina Center
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
Facility Name
Southeastern Retina Associates Chattanooga
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Charles Retina Institute
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Tennessee Retina PC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Austin Retina Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705-1169
Country
United States
Facility Name
Austin Clinical Research LLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78750
Country
United States
Facility Name
Retina Foundation of the Southwest
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Retina Consultants of Texas
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384-4167
Country
United States
Facility Name
Spokane Eye Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Learn more about this trial

A Study Assessing the Long-Term Safety and Tolerability of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

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