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
* 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 * 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 at Week 16 Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale | Baseline, Week 16 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in BCVA in the Study Eye at Week 20 Using the ETDRS Scale | Baseline, Week 20 | 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. |
| Percentage of Patients With a BCVA Gain of 15 or More Letters in the Study Eye Using the ETDRS Scale | Baseline, Week 20 | 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. |
| Percentage of Patients With a BCVA Gain of 10 or More Letters in the Study Eye Using the ETDRS Scale | Baseline, Week 20 | 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. |
| Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye | Baseline, Week 16, Week 20 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| 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 |
| 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 |
Baseline characteristics
| Characteristic | Abicipar Pegol 1 mg | Abicipar Pegol 2 mg | Ranibizumab 0.5 mg | Total |
|---|---|---|---|---|
| Age, Customized ≤ 65 years | 0 participants | 0 participants | 0 participants | 0 participants |
| Age, Customized > 65 years | 10 participants | 10 participants | 5 participants | 25 participants |
| Sex: Female, Male Female | 9 Participants | 7 Participants | 4 Participants | 20 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 1 Participants | 5 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 | 5 / 10 | 6 / 10 | 2 / 5 |
| serious Total, serious adverse events | 1 / 10 | 1 / 10 | 0 / 5 |
Outcome results
Primary
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 16 Using 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.
Time frame: Baseline, Week 16
Population: Modified Intent-to-Treat (mITT) population included all randomized and treated participants with at least 1 follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abicipar Pegol 1 mg | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 16 Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale | Baseline | 55.2 letters | Standard Deviation 12.97 |
| Abicipar Pegol 1 mg | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 16 Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale | Change from Baseline at Week 16 | 4.4 letters | Standard Deviation 8.96 |
| Abicipar Pegol 2 mg | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 16 Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale | Baseline | 59.0 letters | Standard Deviation 10.36 |
| Abicipar Pegol 2 mg | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 16 Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale | Change from Baseline at Week 16 | 10.1 letters | Standard Deviation 10.5 |
| Ranibizumab 0.5 mg | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 16 Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale | Baseline | 57.6 letters | Standard Deviation 17.04 |
| Ranibizumab 0.5 mg | Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 16 Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale | Change from Baseline at Week 16 | 15.2 letters | Standard Deviation 6.72 |
Secondary
Change From Baseline in BCVA in the Study Eye at Week 20 Using 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.
Time frame: Baseline, Week 20
Population: mITT population included all randomized and treated participants with at least 1 follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abicipar Pegol 1 mg | Change From Baseline in BCVA in the Study Eye at Week 20 Using the ETDRS Scale | Baseline | 55.2 letters | Standard Deviation 12.97 |
| Abicipar Pegol 1 mg | Change From Baseline in BCVA in the Study Eye at Week 20 Using the ETDRS Scale | Change from Baseline at Week 20 | 5.6 letters | Standard Deviation 12.12 |
| Abicipar Pegol 2 mg | Change From Baseline in BCVA in the Study Eye at Week 20 Using the ETDRS Scale | Baseline | 59.0 letters | Standard Deviation 10.36 |
| Abicipar Pegol 2 mg | Change From Baseline in BCVA in the Study Eye at Week 20 Using the ETDRS Scale | Change from Baseline at Week 20 | 6.7 letters | Standard Deviation 15.98 |
| Ranibizumab 0.5 mg | Change From Baseline in BCVA in the Study Eye at Week 20 Using the ETDRS Scale | Baseline | 57.6 letters | Standard Deviation 17.04 |
| Ranibizumab 0.5 mg | Change From Baseline in BCVA in the Study Eye at Week 20 Using the ETDRS Scale | Change from Baseline at Week 20 | 14.4 letters | Standard Deviation 7.89 |
Secondary
Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
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.
Time frame: Baseline, Week 16, Week 20
Population: mITT population included all randomized and treated participants with at least 1 follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Abicipar Pegol 1 mg | Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye | Change from Baseline at Week 16 | -106.5 microns | Standard Deviation 128.5 |
| Abicipar Pegol 1 mg | Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye | Baseline | 443.8 microns | Standard Deviation 107.32 |
| Abicipar Pegol 1 mg | Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye | Change from Baseline at Week 20 | -78.2 microns | Standard Deviation 104.73 |
| Abicipar Pegol 2 mg | Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye | Change from Baseline at Week 16 | -112.8 microns | Standard Deviation 169.75 |
| Abicipar Pegol 2 mg | Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye | Baseline | 383.8 microns | Standard Deviation 146.9 |
| Abicipar Pegol 2 mg | Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye | Change from Baseline at Week 20 | -90.3 microns | Standard Deviation 178.22 |
| Ranibizumab 0.5 mg | Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye | Baseline | 348.8 microns | Standard Deviation 33.26 |
| Ranibizumab 0.5 mg | Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye | Change from Baseline at Week 20 | -110.4 microns | Standard Deviation 45.87 |
| Ranibizumab 0.5 mg | Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye | Change from Baseline at Week 16 | -124.4 microns | Standard Deviation 49.51 |
Secondary
Percentage of Patients With a BCVA Gain of 10 or More Letters in the Study Eye Using 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.
Time frame: Baseline, Week 20
Population: mITT population included all randomized and treated participants with at least 1 follow-up visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abicipar Pegol 1 mg | Percentage of Patients With a BCVA Gain of 10 or More Letters in the Study Eye Using the ETDRS Scale | 40.0 percentage of participants |
| Abicipar Pegol 2 mg | Percentage of Patients With a BCVA Gain of 10 or More Letters in the Study Eye Using the ETDRS Scale | 40.0 percentage of participants |
| Ranibizumab 0.5 mg | Percentage of Patients With a BCVA Gain of 10 or More Letters in the Study Eye Using the ETDRS Scale | 60.0 percentage of participants |
Secondary
Percentage of Patients With a BCVA Gain of 15 or More Letters in the Study Eye Using 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.
Time frame: Baseline, Week 20
Population: mITT population included all randomized and treated participants with at least 1 follow-up visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abicipar Pegol 1 mg | Percentage of Patients With a BCVA Gain of 15 or More Letters in the Study Eye Using the ETDRS Scale | 30.0 percentage of participants |
| Abicipar Pegol 2 mg | Percentage of Patients With a BCVA Gain of 15 or More Letters in the Study Eye Using the ETDRS Scale | 30.0 percentage of participants |
| Ranibizumab 0.5 mg | Percentage of Patients With a BCVA Gain of 15 or More Letters in the Study Eye Using the ETDRS Scale | 60.0 percentage of participants |