Trial · NCT02462928
A Safety and Efficacy Study of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration
NCT02462928, Phase 3, Completed, Allergan; results first posted 2020-07-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Safety and Efficacy Study of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration. Trials, record NCT02462928. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02462928
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Efficacy Study of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration
- NCT number
- NCT02462928
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 939 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Macular Degeneration
- Interventions
- Abicipar Pegol, Ranibizumab, Sham Procedure
- First posted
- 2015-06-04
- Last updated
- 2020-07-28
- Other registries' IDs
- eudract:2014-004579-22
- Results first posted
- 2020-07-28
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Stable Vision at Week 52 | Baseline to Week 52 | Stable vision was defined as a loss of fewer than 15 letters in BCVA compared to baseline. BCVA was measured using an eye chart and reported as the number of letters read correctly using the Early Treatment of Diabetic Retinopathy Study (ETDRS) Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of participants with a BCVA loss of fewer than 15 letters are reported. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye. |
| Secondary | Mean Change From Baseline in BCVA in the Study Eye at Week 52 | Baseline to Week 52 | BCVA was measured using an eye chart and was reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their nondominant eye for treatment, or else the right eye was selected as the study eye. Mixed model for repeated measures (MMRM) analysis was used. |
| Secondary | Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 52 | Baseline to Week 52 | CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye. MMRM analysis was used. |
| Secondary | Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in Study Eye at Week 52 | Baseline to Week 52 | BCVA was measured using an eye chart and reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye. |
| Secondary | Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score in Study Eye at Week 52 | Baseline to Week 52 | NEI-VFQ-25 consists of 25 vision-targeted questions that represent 11 vision-related quality of life subscales and one general health item. Responses of individual participants were recorded as scores that ranged between 0 (worst) to 100 (best vision related function) with higher scale indicating better vision related function. The overall composite score is then calculated by averaging over all 11 vision-targeted subscale scores, excluding the general health score. Overall composite score was calculated based on mean of non-missing subscales. Study eye was defined as eye that meets entry criteria. If both eyes met all of entry criteria, eye with worse BCVA at baseline (day 1) was selected. If BCVA values for both eyes were identical then participant had to select non-dominant eye, or else right eye was selected as study eye. A positive change from baseline indicates improvement. MMRM analysis was used. |
Source ClinicalTrials.gov
Outcomes5
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 Stable Vision at Week 52 | Baseline to Week 52 | The per-protocol (PP) population included all randomized and treated participants without any protocol deviations that impacted the primary efficacy variable and with treatment compliance to represent the intended regimen adequately. | percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline in BCVA in the Study Eye at Week 52 | Baseline to Week 52 | The PP population included all randomized and treated participants without any protocol deviations that impacted the primary efficacy variable and with treatment compliance to represent the intended regimen adequately. Number of participants analyzed was based on observed data; missing data were not imputed. | letters | MEAN |
| SECONDARY | Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 52 | Baseline to Week 52 | ITT population included all randomized participants. Number of participants analyzed was based on observed data; missing data were not imputed. | microns | MEAN |
| SECONDARY | Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in Study Eye at Week 52 | Baseline to Week 52 | ITT population included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score in Study Eye at Week 52 | Baseline to Week 52 | ITT population included all randomized participants. Number of participants analyzed was based on observed data; missing data were not imputed. | score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group15
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 Stable Vision at Week 52 | Abicipar Pegol 2 mg (2Q8) | 91.7 | percentage of participants | ||
| Percentage of Participants With Stable Vision at Week 52 | Abicipar Pegol 2 mg (2Q12) | 91.2 | percentage of participants | ||
| Percentage of Participants With Stable Vision at Week 52 | Ranibizumab 0.5 mg (rQ4) | 95.5 | percentage of participants | ||
| Mean Change From Baseline in BCVA in the Study Eye at Week 52 | Abicipar Pegol 2 mg (2Q8) | 6.7 | Standard Deviation 12.9 | letters | |
| Mean Change From Baseline in BCVA in the Study Eye at Week 52 | Abicipar Pegol 2 mg (2Q12) | 5.6 | Standard Deviation 13.3 | letters | |
| Mean Change From Baseline in BCVA in the Study Eye at Week 52 | Ranibizumab 0.5 mg (rQ4) | 8.5 | Standard Deviation 13.6 | letters | |
| Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 52 | Abicipar Pegol 2 mg (2Q8) | -141.5 | Standard Deviation 136.4 | microns | |
| Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 52 | Abicipar Pegol 2 mg (2Q12) | -150.1 | Standard Deviation 127.4 | microns | |
| Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 52 | Ranibizumab 0.5 mg (rQ4) | -141.3 | Standard Deviation 122.0 | microns | |
| Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in Study Eye at Week 52 | Abicipar Pegol 2 mg (2Q8) | 22.6 | percentage of participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Abicipar Pegol 2 mg (2Q8) | 314 | |
| Overall Study | STARTED | Abicipar Pegol 2 mg (2Q12) | 313 | |
| Overall Study | STARTED | Ranibizumab 0.5 mg (rQ4) | 312 | |
| Overall Study | COMPLETED | Abicipar Pegol 2 mg (2Q8) | 224 | |
| Overall Study | COMPLETED | Abicipar Pegol 2 mg (2Q12) | 221 | |
| Overall Study | COMPLETED | Ranibizumab 0.5 mg (rQ4) | 255 | |
| Overall Study | NOT COMPLETED | Abicipar Pegol 2 mg (2Q8) | 90 | |
| Overall Study | NOT COMPLETED | Abicipar Pegol 2 mg (2Q12) | 92 | |
| Overall Study | NOT COMPLETED | Ranibizumab 0.5 mg (rQ4) | 57 |
Source ClinicalTrials.gov
Adverse events924
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 | Abicipar Pegol 2 mg (2Q8) | 27 | 312 | |
| other | Conjunctival haemorrhage | Eye disorders | Abicipar Pegol 2 mg (2Q12) | 32 | 312 | |
| other | Conjunctival haemorrhage | Eye disorders | Ranibizumab 0.5 mg (rQ4) | 46 | 310 | |
| other | Neovascular age-related macular degeneration | Eye disorders | Abicipar Pegol 2 mg (2Q8) | 26 | 312 | |
| other | Neovascular age-related macular degeneration | Eye disorders | Abicipar Pegol 2 mg (2Q12) | 28 | 312 | |
| other | Neovascular age-related macular degeneration | Eye disorders | Ranibizumab 0.5 mg (rQ4) | 39 | 310 | |
| other | Eye pain | Eye disorders | Abicipar Pegol 2 mg (2Q8) | 26 | 312 | |
| other | Eye pain | Eye disorders | Abicipar Pegol 2 mg (2Q12) | 26 | 312 | |
| other | Eye pain | Eye disorders | Ranibizumab 0.5 mg (rQ4) | 22 | 310 | |
| other | Cataract | Eye disorders | Abicipar Pegol 2 mg (2Q8) | 29 | 312 |
1 to 10 of 924Source ClinicalTrials.gov
See all 924 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Abicipar Pegol 2 mg (2Q8) | 8 | 312 |
| Total, all-cause mortality | Abicipar Pegol 2 mg (2Q12) | 7 | 312 |
| Total, all-cause mortality | Ranibizumab 0.5 mg (rQ4) | 11 | 310 |
| Total, other adverse events | Abicipar Pegol 2 mg (2Q8) | 202 | 312 |
| Total, other adverse events | Abicipar Pegol 2 mg (2Q12) | 217 | 312 |
| Total, other adverse events | Ranibizumab 0.5 mg (rQ4) | 196 | 310 |
| Total, serious adverse events | Abicipar Pegol 2 mg (2Q8) | 92 | 312 |
| Total, serious adverse events | Abicipar Pegol 2 mg (2Q12) | 102 | 312 |
| Total, serious adverse events | Ranibizumab 0.5 mg (rQ4) | 95 | 310 |
Source ClinicalTrials.gov
Papers0
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/NCT02462928
GET https://conductscience.org/api/trials/v1/NCT02462928/events?page=2