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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

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04607148
Enrollment
144
Registered
2020-10-29
Start date
2020-11-16
Completion date
2022-11-14
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Geographic Atrophy, Macular Degeneration, Age-Related

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).

Interventions

DRUGGalegenimab

Intravitreal (ITV) injections of galegenimab

Sponsors

Genentech, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes 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.

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants With Ocular Adverse EventsFrom baseline up to Week 104An 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 EventsFrom Baseline up to Week 104An 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Galegenimab 10MG Q4W
Participants will receive 10 milligrams (mg) galegenimab via intravitreal (ITV) injection every 4 weeks (Q4W).
14
Galegenimab 20MG Q4W
Participants will receive 20 mg galegenimab via ITV injection Q4W.
70
Galegenimab 10MG Q8W
Participants will receive 10 mg galegenimab via ITV injection Q8W.
12
Galegenimab 20MG Q8W
Participants will receive 20 mg galegenimab via ITV injection Q8W.
48
Total144

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyAdverse Event0100
Overall StudyDeath0301
Overall StudyLost to Follow-up0200
Overall StudyNon-Compliance With Study Drug0100
Overall StudySponsor Decision0010
Overall StudyStudy Terminated by Sponsor1459939
Overall StudyWithdrawal by Subject0428

Baseline characteristics

CharacteristicGalegenimab 10MG Q4WGalegenimab 20MG Q4WGalegenimab 10MG Q8WGalegenimab 20MG Q8WTotal
Age, Continuous77.3 Years
STANDARD_DEVIATION 5.4
80.2 Years
STANDARD_DEVIATION 7.2
78.1 Years
STANDARD_DEVIATION 6.9
78.8 Years
STANDARD_DEVIATION 8.5
79.3 Years
STANDARD_DEVIATION 7.5
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants3 Participants0 Participants1 Participants4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
14 Participants67 Participants12 Participants47 Participants140 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
14 Participants69 Participants12 Participants48 Participants143 Participants
Sex: Female, Male
Female
9 Participants41 Participants6 Participants30 Participants86 Participants
Sex: Female, Male
Male
5 Participants29 Participants6 Participants18 Participants58 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 143 / 700 / 121 / 48
other
Total, other adverse events
13 / 1426 / 706 / 1214 / 48
serious
Total, serious adverse events
1 / 1413 / 702 / 1210 / 48

Outcome results

Primary

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.

Time frame: From baseline up to Week 104

Population: Safety analysis population included all randomized participants who received at least one dose of study drug.

ArmMeasureValue (NUMBER)
Galegenimab 10MG Q4WPercentage of Participants With Ocular Adverse Events50 Percentage of Participants
Galegenimab 20MG Q4WPercentage of Participants With Ocular Adverse Events42.9 Percentage of Participants
Galegenimab 10MG Q8WPercentage of Participants With Ocular Adverse Events25 Percentage of Participants
Galegenimab 20MG Q8WPercentage of Participants With Ocular Adverse Events27.1 Percentage of Participants
Primary

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.

Time frame: From Baseline up to Week 104

Population: Safety analysis population included all randomized participants who received at least one dose of study drug.

ArmMeasureValue (NUMBER)
Galegenimab 10MG Q4WPercentage of Participants With Systemic (Non-Ocular) Adverse Events71.4 Percentage of Participants
Galegenimab 20MG Q4WPercentage of Participants With Systemic (Non-Ocular) Adverse Events70 Percentage of Participants
Galegenimab 10MG Q8WPercentage of Participants With Systemic (Non-Ocular) Adverse Events33.3 Percentage of Participants
Galegenimab 20MG Q8WPercentage of Participants With Systemic (Non-Ocular) Adverse Events47.9 Percentage of Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026