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Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OMASPECT)

A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Lampalizumab in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration Who Have Completed a Roche-Sponsored Study

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02745119
Enrollment
994
Registered
2016-04-20
Start date
2016-07-21
Completion date
2018-01-31
Last updated
2019-03-06

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

Conditions

Geographic Atrophy

Brief summary

This multicenter open-label extension study is designed to evaluate the safety and tolerability of lampalizumab intravitreal injections in participants with GA secondary to age-related macular degeneration (AMD) who completed 96 weeks of treatment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531). The extension will enroll participants from the parent studies who received investigational lampalizumab, as well as lampalizumab-naive participants exposed to sham comparator. All participants will receive open-label lampalizumab in the present study.

Interventions

DRUGLampalizumab

Lampalizumab 10 mg will be administered every 4 or 6 weeks according to the frequency given during participation in the parent study.

Sponsors

Hoffmann-La Roche
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Previous enrollment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531) with completion of treatment and the Week 96 visit * Agreement to remain abstinent or use a reliable form of contraception among all men and among women of child-bearing potential

Exclusion criteria

* Concurrent ocular conditions that contraindicate use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications * Concurrent disease, metabolic dysfunction, or physical or laboratory finding that contraindicates use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications * Increased risk of infection * Pregnancy or lactation

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants With Ocular Adverse Events (AEs) by SeverityUp to approximately one yearAn 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) AEs by SeverityUp to approximately one yearAn 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.
Percentage of Participants With Anti-Lampalizumab AntibodiesWeek 48The immunogenicity analysis included participants with at least one predose and one postdose anti-lampalizumab antibodies assessment. Predose was defined as prior to the first dose in the extension study for the prior sham participants, and prior to the first dose in the parent study for the prior lampalizumab participants.

Countries

Australia, Austria, Belgium, Canada, Denmark, France, Germany, Hungary, Italy, Netherlands, Peru, Poland, Portugal, Slovakia, Spain, Switzerland, Turkey (Türkiye), United Kingdom, United States

Participant flow

Recruitment details

994 participants enrolled in study . study terminated early by Sponsor due to lack of efficacy. 842 patients received at least one lampalizumab injection 152 patients enrolled in Study GX30191 did not receive study drug in the extension study and thus were excluded from the safety-evaluable population.

Pre-assignment details

Eligible participants were those who enrolled in Studies GX29176 (NCT02247479) and GX29185 (NCT02247531) and had completed the 96-week treatment period without early treatment discontinuation or study discontinuation.

Participants by arm

ArmCount
Lampalizumab Q4W - Treatment-Naive
Participants who received sham comparator every 4 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 milligrams (mg), by intravitreal (ITV) injection, administered every 4 weeks.
145
Lampalizumab Q4W - Previously Treated
Participants who received lampalizumab every 4 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 4 weeks.
274
Lampalizumab Q6W - Treatment-Naive
Participants who received sham comparator every 6 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 6 weeks.
146
Lampalizumab Q6W - Previously Treated
Participants who received lampalizumab every 6 weeks in one of the parent studies and completed the Week 96 visit received lampalizumab, 10 mg, by ITV injection, administered every 6 weeks.
277
Total842

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyAdverse Event1013
Overall StudyDeath3304
Overall StudyLost to Follow-up0001
Overall StudyPhysician Decision0222
Overall StudyProtocol Deviation0001
Overall StudyReason Not Specified0201
Overall StudyStudy Terminated by Sponsor134252135251
Overall StudyWithdrawal by Subject715814

Baseline characteristics

CharacteristicLampalizumab Q4W - Treatment-NaiveTotalLampalizumab Q4W - Previously TreatedLampalizumab Q6W - Treatment-NaiveLampalizumab Q6W - Previously Treated
Age, Continuous79.0 years
STANDARD_DEVIATION 8.2
79.3 years
STANDARD_DEVIATION 8
78.7 years
STANDARD_DEVIATION 7.8
79.2 years
STANDARD_DEVIATION 8.6
80.2 years
STANDARD_DEVIATION 7.9
Race/Ethnicity, Customized
American Indian or Alaska Native
0 Participants2 Participants1 Participants1 Participants0 Participants
Race/Ethnicity, Customized
Asian
0 Participants1 Participants0 Participants1 Participants0 Participants
Race/Ethnicity, Customized
Black or African American
0 Participants1 Participants1 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Hispanic or Latino
2 Participants21 Participants3 Participants4 Participants12 Participants
Race/Ethnicity, Customized
Multiple
0 Participants4 Participants0 Participants2 Participants2 Participants
Race/Ethnicity, Customized
Not Hispanic or Latino
140 Participants810 Participants267 Participants140 Participants263 Participants
Race/Ethnicity, Customized
Not Reported
0 Participants4 Participants2 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Unknown
0 Participants7 Participants3 Participants1 Participants1 Participants
Race/Ethnicity, Customized
White
145 Participants827 Participants269 Participants141 Participants272 Participants
Sex: Female, Male
Female
82 Participants492 Participants167 Participants79 Participants164 Participants
Sex: Female, Male
Male
63 Participants350 Participants107 Participants67 Participants113 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
3 / 1453 / 2740 / 1469 / 27715 / 842
other
Total, other adverse events
41 / 14563 / 27426 / 14656 / 277186 / 842
serious
Total, serious adverse events
31 / 14558 / 27414 / 14650 / 277153 / 842

Outcome results

Primary

Percentage of Participants With Anti-Lampalizumab Antibodies

The immunogenicity analysis included participants with at least one predose and one postdose anti-lampalizumab antibodies assessment. Predose was defined as prior to the first dose in the extension study for the prior sham participants, and prior to the first dose in the parent study for the prior lampalizumab participants.

Time frame: Week 48

Population: The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study. Data is reported for evaluable participants.

ArmMeasureValue (NUMBER)
Lampalizumab Q4W - Treatment-NaivePercentage of Participants With Anti-Lampalizumab Antibodies0.0 percentage of participants
Lampalizumab Q4W - Previously TreatedPercentage of Participants With Anti-Lampalizumab Antibodies0.0 percentage of participants
Lampalizumab Q6W - Treatment-NaivePercentage of Participants With Anti-Lampalizumab Antibodies0.0 percentage of participants
Lampalizumab Q6W - Previously TreatedPercentage of Participants With Anti-Lampalizumab Antibodies0.0 percentage of participants
All ParticipantsPercentage of Participants With Anti-Lampalizumab Antibodies0.0 percentage of participants
Primary

Percentage of Participants With Ocular Adverse Events (AEs) by Severity

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: Up to approximately one year

Population: The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.

ArmMeasureGroupValue (NUMBER)
Lampalizumab Q4W - Treatment-NaivePercentage of Participants With Ocular Adverse Events (AEs) by SeverityAny severity37.2 percentage of participants
Lampalizumab Q4W - Treatment-NaivePercentage of Participants With Ocular Adverse Events (AEs) by SeverityMild25.5 percentage of participants
Lampalizumab Q4W - Treatment-NaivePercentage of Participants With Ocular Adverse Events (AEs) by SeverityModerate9.7 percentage of participants
Lampalizumab Q4W - Treatment-NaivePercentage of Participants With Ocular Adverse Events (AEs) by SeveritySevere2.1 percentage of participants
Lampalizumab Q4W - Previously TreatedPercentage of Participants With Ocular Adverse Events (AEs) by SeverityAny severity40.1 percentage of participants
Lampalizumab Q4W - Previously TreatedPercentage of Participants With Ocular Adverse Events (AEs) by SeveritySevere2.2 percentage of participants
Lampalizumab Q4W - Previously TreatedPercentage of Participants With Ocular Adverse Events (AEs) by SeverityMild26.6 percentage of participants
Lampalizumab Q4W - Previously TreatedPercentage of Participants With Ocular Adverse Events (AEs) by SeverityModerate11.3 percentage of participants
Lampalizumab Q6W - Treatment-NaivePercentage of Participants With Ocular Adverse Events (AEs) by SeveritySevere0 percentage of participants
Lampalizumab Q6W - Treatment-NaivePercentage of Participants With Ocular Adverse Events (AEs) by SeverityMild16.4 percentage of participants
Lampalizumab Q6W - Treatment-NaivePercentage of Participants With Ocular Adverse Events (AEs) by SeverityModerate8.2 percentage of participants
Lampalizumab Q6W - Treatment-NaivePercentage of Participants With Ocular Adverse Events (AEs) by SeverityAny severity24.7 percentage of participants
Lampalizumab Q6W - Previously TreatedPercentage of Participants With Ocular Adverse Events (AEs) by SeverityAny severity33.2 percentage of participants
Lampalizumab Q6W - Previously TreatedPercentage of Participants With Ocular Adverse Events (AEs) by SeverityMild21.7 percentage of participants
Lampalizumab Q6W - Previously TreatedPercentage of Participants With Ocular Adverse Events (AEs) by SeveritySevere1.4 percentage of participants
Lampalizumab Q6W - Previously TreatedPercentage of Participants With Ocular Adverse Events (AEs) by SeverityModerate10.1 percentage of participants
All ParticipantsPercentage of Participants With Ocular Adverse Events (AEs) by SeveritySevere1.5 percentage of participants
All ParticipantsPercentage of Participants With Ocular Adverse Events (AEs) by SeverityModerate10.1 percentage of participants
All ParticipantsPercentage of Participants With Ocular Adverse Events (AEs) by SeverityMild23.0 percentage of participants
All ParticipantsPercentage of Participants With Ocular Adverse Events (AEs) by SeverityAny severity34.7 percentage of participants
Primary

Percentage of Participants With Systemic (Non-Ocular) AEs by Severity

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: Up to approximately one year

Population: The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.

ArmMeasureGroupValue (NUMBER)
Lampalizumab Q4W - Treatment-NaivePercentage of Participants With Systemic (Non-Ocular) AEs by SeverityAny severity55.2 percentage of participants
Lampalizumab Q4W - Treatment-NaivePercentage of Participants With Systemic (Non-Ocular) AEs by SeverityMild18.6 percentage of participants
Lampalizumab Q4W - Treatment-NaivePercentage of Participants With Systemic (Non-Ocular) AEs by SeverityModerate28.3 percentage of participants
Lampalizumab Q4W - Treatment-NaivePercentage of Participants With Systemic (Non-Ocular) AEs by SeveritySevere8.3 percentage of participants
Lampalizumab Q4W - Previously TreatedPercentage of Participants With Systemic (Non-Ocular) AEs by SeverityAny severity54.0 percentage of participants
Lampalizumab Q4W - Previously TreatedPercentage of Participants With Systemic (Non-Ocular) AEs by SeveritySevere13.5 percentage of participants
Lampalizumab Q4W - Previously TreatedPercentage of Participants With Systemic (Non-Ocular) AEs by SeverityMild20.1 percentage of participants
Lampalizumab Q4W - Previously TreatedPercentage of Participants With Systemic (Non-Ocular) AEs by SeverityModerate20.4 percentage of participants
Lampalizumab Q6W - Treatment-NaivePercentage of Participants With Systemic (Non-Ocular) AEs by SeveritySevere5.5 percentage of participants
Lampalizumab Q6W - Treatment-NaivePercentage of Participants With Systemic (Non-Ocular) AEs by SeverityMild17.8 percentage of participants
Lampalizumab Q6W - Treatment-NaivePercentage of Participants With Systemic (Non-Ocular) AEs by SeverityModerate18.5 percentage of participants
Lampalizumab Q6W - Treatment-NaivePercentage of Participants With Systemic (Non-Ocular) AEs by SeverityAny severity41.8 percentage of participants
Lampalizumab Q6W - Previously TreatedPercentage of Participants With Systemic (Non-Ocular) AEs by SeverityAny severity51.3 percentage of participants
Lampalizumab Q6W - Previously TreatedPercentage of Participants With Systemic (Non-Ocular) AEs by SeverityMild20.9 percentage of participants
Lampalizumab Q6W - Previously TreatedPercentage of Participants With Systemic (Non-Ocular) AEs by SeveritySevere10.1 percentage of participants
Lampalizumab Q6W - Previously TreatedPercentage of Participants With Systemic (Non-Ocular) AEs by SeverityModerate20.2 percentage of participants
All ParticipantsPercentage of Participants With Systemic (Non-Ocular) AEs by SeveritySevere10.1 percentage of participants
All ParticipantsPercentage of Participants With Systemic (Non-Ocular) AEs by SeverityModerate21.4 percentage of participants
All ParticipantsPercentage of Participants With Systemic (Non-Ocular) AEs by SeverityMild19.7 percentage of participants
All ParticipantsPercentage of Participants With Systemic (Non-Ocular) AEs by SeverityAny severity51.2 percentage of participants

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