Trial · NCT02745119
Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OMASPECT)
NCT02745119, Phase 3, Terminated, Hoffmann-La Roche; results first posted 2019-02-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OMASPECT). Trials, record NCT02745119. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02745119
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OMASPECT)
- NCT number
- NCT02745119
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 994 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Geographic Atrophy
- Interventions
- Lampalizumab
- First posted
- 2016-04-20
- Last updated
- 2019-03-06
- Other registries' IDs
- eudract:2016-000423-13
- Results first posted
- 2019-02-15
- Limitations and caveats
- This study was terminated early by the Sponsor because the compound had demonstrated lack of efficacy. Thus, no participant in this study completed the full duration of treatment.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Ocular Adverse Events (AEs) by Severity | Up to approximately one year | 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. |
| Primary | Percentage of Participants With Systemic (Non-Ocular) AEs by Severity | Up to approximately one year | 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. |
| Primary | Percentage of Participants With Anti-Lampalizumab Antibodies | Week 48 | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Ocular Adverse Events (AEs) by Severity | Up to approximately one year | The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Systemic (Non-Ocular) AEs by Severity | Up to approximately one year | The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Anti-Lampalizumab Antibodies | Week 48 | 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. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Ocular Adverse Events (AEs) by Severity | Lampalizumab Q4W - Treatment-Naive | Any severity | 37.2 | percentage of participants | |
| Percentage of Participants With Ocular Adverse Events (AEs) by Severity | Lampalizumab Q4W - Previously Treated | Any severity | 40.1 | percentage of participants | |
| Percentage of Participants With Ocular Adverse Events (AEs) by Severity | Lampalizumab Q6W - Treatment-Naive | Any severity | 24.7 | percentage of participants | |
| Percentage of Participants With Ocular Adverse Events (AEs) by Severity | Lampalizumab Q6W - Previously Treated | Any severity | 33.2 | percentage of participants | |
| Percentage of Participants With Ocular Adverse Events (AEs) by Severity | All Participants | Any severity | 34.7 | percentage of participants | |
| Percentage of Participants With Ocular Adverse Events (AEs) by Severity | Lampalizumab Q4W - Treatment-Naive | Mild | 25.5 | percentage of participants | |
| Percentage of Participants With Ocular Adverse Events (AEs) by Severity | Lampalizumab Q4W - Previously Treated | Mild | 26.6 | percentage of participants | |
| Percentage of Participants With Ocular Adverse Events (AEs) by Severity | Lampalizumab Q6W - Treatment-Naive | Mild | 16.4 | percentage of participants | |
| Percentage of Participants With Ocular Adverse Events (AEs) by Severity | Lampalizumab Q6W - Previously Treated | Mild | 21.7 | percentage of participants | |
| Percentage of Participants With Ocular Adverse Events (AEs) by Severity | All Participants | Mild | 23.0 | percentage of participants |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lampalizumab Q4W - Treatment-Naive | 145 | |
| Overall Study | STARTED | Lampalizumab Q4W - Previously Treated | 274 | |
| Overall Study | STARTED | Lampalizumab Q6W - Treatment-Naive | 146 | |
| Overall Study | STARTED | Lampalizumab Q6W - Previously Treated | 277 | |
| Overall Study | COMPLETED | Lampalizumab Q4W - Treatment-Naive | 0 | |
| Overall Study | COMPLETED | Lampalizumab Q4W - Previously Treated | 0 | |
| Overall Study | COMPLETED | Lampalizumab Q6W - Treatment-Naive | 0 | |
| Overall Study | COMPLETED | Lampalizumab Q6W - Previously Treated | 0 | |
| Overall Study | NOT COMPLETED | Lampalizumab Q4W - Treatment-Naive | 145 | |
| Overall Study | NOT COMPLETED | Lampalizumab Q4W - Previously Treated | 274 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events695
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Conjunctival haemorrhage | Eye disorders | Lampalizumab Q4W - Treatment-Naive | 17 | 145 | |
| other | Conjunctival haemorrhage | Eye disorders | Lampalizumab Q4W - Previously Treated | 17 | 274 | |
| other | Conjunctival haemorrhage | Eye disorders | Lampalizumab Q6W - Treatment-Naive | 12 | 146 | |
| other | Conjunctival haemorrhage | Eye disorders | Lampalizumab Q6W - Previously Treated | 20 | 277 | |
| other | Conjunctival haemorrhage | Eye disorders | All Participants | 66 | 842 | |
| other | Eye pain | Eye disorders | Lampalizumab Q4W - Treatment-Naive | 8 | 145 | |
| other | Eye pain | Eye disorders | Lampalizumab Q4W - Previously Treated | 8 | 274 | |
| other | Eye pain | Eye disorders | Lampalizumab Q6W - Treatment-Naive | 5 | 146 | |
| other | Eye pain | Eye disorders | Lampalizumab Q6W - Previously Treated | 11 | 277 | |
| other | Eye pain | Eye disorders | All Participants | 32 | 842 |
1 to 10 of 695Source ClinicalTrials.gov
See all 695 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lampalizumab Q4W - Treatment-Naive | 3 | 145 |
| Total, all-cause mortality | Lampalizumab Q4W - Previously Treated | 3 | 274 |
| Total, all-cause mortality | Lampalizumab Q6W - Treatment-Naive | 0 | 146 |
| Total, all-cause mortality | Lampalizumab Q6W - Previously Treated | 9 | 277 |
| Total, all-cause mortality | All Participants | 15 | 842 |
| Total, other adverse events | Lampalizumab Q4W - Treatment-Naive | 41 | 145 |
| Total, other adverse events | Lampalizumab Q4W - Previously Treated | 63 | 274 |
| Total, other adverse events | Lampalizumab Q6W - Treatment-Naive | 26 | 146 |
| Total, other adverse events | Lampalizumab Q6W - Previously Treated | 56 | 277 |
| Total, other adverse events | All Participants | 186 | 842 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02745119
GET https://conductscience.org/api/trials/v1/NCT02745119/results?page=2