Macular Degeneration
Conditions
Brief summary
The objective of this study is to evaluate abicipar pegol for safety and treatment effects in participants with neovascular age-related macular degeneration (AMD).
Interventions
DRUGAbicipar pegol
Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female participants, 50 years of age or older at the time of informed consent * Best Corrected Visual Acuity (BCVA) ≤ 78 and ≥ 24 letters (20/32 to 20/320 Snellen equivalents, respectively) at Screening and at Baseline (Day 1, prior to treatment) visits in the study eye * BCVA of 34 letters (Snellen equivalent 20/200) or better at Baseline (Day 1, prior to treatment) in the non-study eye
Exclusion criteria
* Active periocular, ocular, or intraocular infection at baseline (Day 1) (either eye) * Previous or concurrent macular laser treatment (study eye) * Cataract or refractive surgery within 3 months prior to baseline (study eye)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Stable Vision | Baseline (Day 1) to Week 28 | Stable vision was defined as a loss of fewer than 15 letters in Best Corrected Visual Acuity (BCVA) compared to baseline. BCVA was measured using an eye chart and is 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 study eye was 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye | Baseline (Day 1) to Week 28 | 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. |
| Percentage of Participants With Loss of 15 or Less EDTRS Letters in BCVA From Baseline in the Study Eye | Baseline (Day 1) to Week 28 | BCVA was 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 study eye was 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. |
| Change Form Baseline in BCVA in the Study Eye | Baseline (Day 1) to Week 28 | BCVA was 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 study eye was 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. |
| Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in the Study Eye | Baseline (Day 1), Week 28 | BCVA was 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 study eye was 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. |
Other
| Measure | Time frame |
|---|---|
| Percentage of Participants With Change From Baseline in Full Ophthalmic Exam Findings [i.e. Slit Lamp Exam, Intraocular Pressure (IOP) Measurements, Funduscopic Exam] | Baseline to Week 28 |
| Changes From Baseline in General Physical Condition as Measured Through General Physical Exam | Baseline to Week 28 |
| Percentage of Participants With Changes From Baseline in Vital Signs (Blood Pressure, Pulse Rate, ECG) | Baseline to Week 28 |
| Percentage of Participants With Change From Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis) | Baseline to Week 28 |
| Percentage of Participants With Anti-abicipar Antibodies Measured in Serum | Baseline to Week 28 |
Countries
United States
Participant flow
Pre-assignment details
A total of 124 participants were enrolled in the study. Out of 124, one participant was not treated with study drug and was subsequently discontinued from the study. The participant was not included in the Safety Population or analyses.
Participants by arm
| Arm | Count |
|---|---|
| Abicipar Pegol 2 mg Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24. | 123 |
| Total | 123 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 12 |
| Overall Study | Death | 2 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Progressive Disease | 1 |
| Overall Study | Reason not Specified | 1 |
Baseline characteristics
| Characteristic | Abicipar Pegol 2 mg |
|---|---|
| Age, Continuous | 78.3 years STANDARD_DEVIATION 8.21 |
| Best Corrected Visual Acuity (BCVA) | 62.0 letters STANDARD_DEVIATION 12.19 |
| Central Retinal Thickness (CRT) | 353.1 microns STANDARD_DEVIATION 94.05 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 119 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 119 Participants |
| Sex: Female, Male Female | 71 Participants |
| Sex: Female, Male Male | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 123 |
| other Total, other adverse events | 0 / 123 |
| serious Total, serious adverse events | 16 / 123 |
Outcome results
Primary
Percentage of Participants With Stable Vision
Stable vision was defined as a loss of fewer than 15 letters in Best Corrected Visual Acuity (BCVA) compared to baseline. BCVA was measured using an eye chart and is 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 study eye was 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.
Time frame: Baseline (Day 1) to Week 28
Population: Safety Population included all participants who received at least 1 administration of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abicipar Pegol 2 mg | Percentage of Participants With Stable Vision | 97.6 percentage of participants |
Secondary
Change Form Baseline in BCVA in the Study Eye
BCVA was 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 study eye was 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.
Time frame: Baseline (Day 1) to Week 28
Population: Safety Population included all participants who received at least 1 administration of study treatment. Overall number of participants analyzed are the participants with data available for analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abicipar Pegol 2 mg | Change Form Baseline in BCVA in the Study Eye | 3.6 letters | Standard Deviation 7.19 |
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. 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.
Time frame: Baseline (Day 1) to Week 28
Population: Safety Population included all participants who received at least 1 administration of study treatment. Number analyzed is the number of participants with data available at the given time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abicipar Pegol 2 mg | Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye | -82.5 microns | Standard Deviation 102.13 |
Secondary
Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in the Study Eye
BCVA was 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 study eye was 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.
Time frame: Baseline (Day 1), Week 28
Population: Safety Population included all participants who received at least 1 administration of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abicipar Pegol 2 mg | Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in the Study Eye | 9.8 percentage of participants |
Secondary
Percentage of Participants With Loss of 15 or Less EDTRS Letters in BCVA From Baseline in the Study Eye
BCVA was 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 study eye was 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.
Time frame: Baseline (Day 1) to Week 28
Population: Safety Population included all participants who received at least 1 administration of study treatment. Overall number of participants analyzed are the participants with data available for analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abicipar Pegol 2 mg | Percentage of Participants With Loss of 15 or Less EDTRS Letters in BCVA From Baseline in the Study Eye | 0.9 percentage of participants |
Other Pre-specified
Changes From Baseline in General Physical Condition as Measured Through General Physical Exam
Time frame: Baseline to Week 28
Other Pre-specified
Percentage of Participants With Anti-abicipar Antibodies Measured in Serum
Time frame: Baseline to Week 28
Other Pre-specified
Percentage of Participants With Change From Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis)
Time frame: Baseline to Week 28
Other Pre-specified
Percentage of Participants With Change From Baseline in Full Ophthalmic Exam Findings [i.e. Slit Lamp Exam, Intraocular Pressure (IOP) Measurements, Funduscopic Exam]
Time frame: Baseline to Week 28
Other Pre-specified
Percentage of Participants With Changes From Baseline in Vital Signs (Blood Pressure, Pulse Rate, ECG)
Time frame: Baseline to Week 28