Macular Degeneration
Conditions
Brief summary
This is a safety and efficacy study of abicipar pegol in patients with neovascular age-related macular degeneration to establish comparability between Japanese and non-Japanese.
Interventions
DRUGabicipar pegol
Abicipar pegol administered to the study eye by intravitreal injection at day 1, weeks 4 and 8.
DRUGranibizumab
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
OTHERsham procedure
Sham procedure to the study eye at weeks 12 and 16.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ethnically Japanese * Diagnosis of wet age-related macular degeneration in at least 1 eye * Best corrected visual acuity of 20/32 to 20/320 in the study eye and 20/200 or better in the fellow eye
Exclusion criteria
* Hypersensitivity, allergy, or anaphylactic reaction to iodine or shellfish * Cataract or refractive surgery within the last 3 months * History of vitrectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline, Week 16 | BCVA is measured using an eye chart and is reported as the number of letters read correctly (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 (positive number change from baseline) in the number of letters read correctly means that vision has improved and a decrease (negative number change from baseline) in the number of letters read correctly means that vision has worsened. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in BCVA in the Study Eye | Baseline, Week 20 | BCVA is measured using an eye chart and is reported as the number of letters read correctly (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 (positive number change from baseline) in the number of letters read correctly means that vision has improved and a decrease (negative number change from baseline) in the number of letters read correctly means that vision has worsened. |
| Percentage of Patients With a BCVA Gain of ≥15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale | Baseline, 20 Weeks | BCVA is measured using an eye chart and is 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 percentage of patients with a BCVA gain of ≥15 letters are noted. |
| Percentage of Patients With a BCVA Gain of ≥10 Letters in the Study Eye on the ETDRS Scale | Baseline, 20 Weeks | BCVA is measured using an eye chart and is 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 percentage of patients with a BCVA gain of ≥10 letters are noted. |
| Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye | Baseline, Week 16, Week 20 | CRT is assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system that provides high-resolution imaging sections of the retina. SD-OCT is performed in the study eye after pupil dilation. A negative change from Baseline indicates improvement and a positive change from baseline indicates worsening. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Abicipar Pegol 2 mg Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16. | 10 |
| Abicipar Pegol 1 mg Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16. | 10 |
| Ranibizumab 0.5 mg Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16. | 5 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Abicipar Pegol 2 mg | Abicipar Pegol 1 mg | Ranibizumab 0.5 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 71.8 Years STANDARD_DEVIATION 5.75 | 75.6 Years STANDARD_DEVIATION 7.18 | 76.6 Years STANDARD_DEVIATION 9.24 | 74.3 Years STANDARD_DEVIATION 7.1 |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 8 Participants | 9 Participants | 4 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 10 | 8 / 10 | 5 / 5 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 2 / 5 |
Outcome results
Primary
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
BCVA is measured using an eye chart and is reported as the number of letters read correctly (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 (positive number change from baseline) in the number of letters read correctly means that vision has improved and a decrease (negative number change from baseline) in the number of letters read correctly means that vision has worsened.
Time frame: Baseline, Week 16
Population: Modified Intent-to-Treat: all randomized and treated patients with at least 1 follow-up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abicipar Pegol 2 mg | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline | 58.5 Letters | Standard Deviation 17.3 |
| Abicipar Pegol 2 mg | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Change from Baseline at Week 16 | 8.9 Letters | Standard Deviation 9.16 |
| Abicipar Pegol 1 mg | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline | 54.3 Letters | Standard Deviation 15.58 |
| Abicipar Pegol 1 mg | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Change from Baseline at Week 16 | 7.8 Letters | Standard Deviation 8.51 |
| Ranibizumab 0.5 mg | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Baseline | 55.8 Letters | Standard Deviation 9.68 |
| Ranibizumab 0.5 mg | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye | Change from Baseline at Week 16 | 17.4 Letters | Standard Deviation 8.08 |
Secondary
Change From Baseline in BCVA in the Study Eye
BCVA is measured using an eye chart and is reported as the number of letters read correctly (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 (positive number change from baseline) in the number of letters read correctly means that vision has improved and a decrease (negative number change from baseline) in the number of letters read correctly means that vision has worsened.
Time frame: Baseline, Week 20
Population: Modified Intent-to-Treat: all randomized and treated patients with at least 1 follow-up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abicipar Pegol 2 mg | Change From Baseline in BCVA in the Study Eye | Baseline | 58.5 Letters | Standard Deviation 17.3 |
| Abicipar Pegol 2 mg | Change From Baseline in BCVA in the Study Eye | Change from Baseline at Week 20 | 9.6 Letters | Standard Deviation 6.75 |
| Abicipar Pegol 1 mg | Change From Baseline in BCVA in the Study Eye | Baseline | 54.3 Letters | Standard Deviation 15.58 |
| Abicipar Pegol 1 mg | Change From Baseline in BCVA in the Study Eye | Change from Baseline at Week 20 | 8.7 Letters | Standard Deviation 7.33 |
| Ranibizumab 0.5 mg | Change From Baseline in BCVA in the Study Eye | Baseline | 55.8 Letters | Standard Deviation 9.68 |
| Ranibizumab 0.5 mg | Change From Baseline in BCVA in the Study Eye | Change from Baseline at Week 20 | 17.2 Letters | Standard Deviation 7.73 |
Secondary
Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
CRT is assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system that provides high-resolution imaging sections of the retina. SD-OCT is performed in the study eye after pupil dilation. A negative change from Baseline indicates improvement and a positive change from baseline indicates worsening.
Time frame: Baseline, Week 16, Week 20
Population: Modified Intent-to-Treat: all randomized and treated patients with at least 1 follow-up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abicipar Pegol 2 mg | Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye | Change from Baseline at Week 16 | -196.5 microns | Standard Deviation 124.2 |
| Abicipar Pegol 2 mg | Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye | Baseline | 438.7 microns | Standard Deviation 107.32 |
| Abicipar Pegol 2 mg | Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye | Change from Baseline at Week 20 | -194.9 microns | Standard Deviation 109.37 |
| Abicipar Pegol 1 mg | Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye | Change from Baseline at Week 16 | -187.3 microns | Standard Deviation 145.63 |
| Abicipar Pegol 1 mg | Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye | Baseline | 475.1 microns | Standard Deviation 192.76 |
| Abicipar Pegol 1 mg | Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye | Change from Baseline at Week 20 | -139.4 microns | Standard Deviation 110.66 |
| Ranibizumab 0.5 mg | Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye | Baseline | 470.0 microns | Standard Deviation 67.75 |
| Ranibizumab 0.5 mg | Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye | Change from Baseline at Week 20 | -250.6 microns | Standard Deviation 50.69 |
| Ranibizumab 0.5 mg | Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye | Change from Baseline at Week 16 | -230.4 microns | Standard Deviation 59.28 |
Secondary
Percentage of Patients With a BCVA Gain of ≥10 Letters in the Study Eye on the ETDRS Scale
BCVA is measured using an eye chart and is 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 percentage of patients with a BCVA gain of ≥10 letters are noted.
Time frame: Baseline, 20 Weeks
Population: Modified Intent-to-Treat: all randomized and treated patients with at least 1 follow-up visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abicipar Pegol 2 mg | Percentage of Patients With a BCVA Gain of ≥10 Letters in the Study Eye on the ETDRS Scale | 50.0 Percentage of Patients |
| Abicipar Pegol 1 mg | Percentage of Patients With a BCVA Gain of ≥10 Letters in the Study Eye on the ETDRS Scale | 50.0 Percentage of Patients |
| Ranibizumab 0.5 mg | Percentage of Patients With a BCVA Gain of ≥10 Letters in the Study Eye on the ETDRS Scale | 80.0 Percentage of Patients |
Secondary
Percentage of Patients With a BCVA Gain of ≥15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale
BCVA is measured using an eye chart and is 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 percentage of patients with a BCVA gain of ≥15 letters are noted.
Time frame: Baseline, 20 Weeks
Population: Modified Intent-to-Treat: all randomized and treated patients with at least 1 follow-up visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abicipar Pegol 2 mg | Percentage of Patients With a BCVA Gain of ≥15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale | 20.0 Percentage of Patients |
| Abicipar Pegol 1 mg | Percentage of Patients With a BCVA Gain of ≥15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale | 30.0 Percentage of Patients |
| Ranibizumab 0.5 mg | Percentage of Patients With a BCVA Gain of ≥15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale | 60.0 Percentage of Patients |