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The objective of this study is to evaluate abicipar pegol for safety and treatment effects in participants with neovascular age-related macular degeneration (AMD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abicipar pegol 2 mg | Experimental | Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abicipar pegol | Drug | Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 1) to Week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne Li, MD | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnet Dulaney Perkins Eye Center | Phoenix | Arizona | 85016 | United States | ||
| Retina Associates Southwest, PC |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 16, 2018 | Jul 17, 2020 |
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| Baseline (Day 1) to Week 28 |
| 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. | Baseline (Day 1) to Week 28 |
| 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. | Baseline (Day 1) to Week 28 |
| 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. | Baseline (Day 1), Week 28 |
| 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 |
| Tucson |
| Arizona |
| 85710 |
| United States |
| Win Retina | Arcadia | California | 91006 | United States |
| Retina Consultants of Orange County | Fullerton | California | 92835 | United States |
| Mark B. Kislinger, MD, Inc. | Glendora | California | 91741 | United States |
| Atlantis Retina Institute (Atlantis Eyecare) | Huntington Beach | California | 92647 | United States |
| N. California Retina Vitreous Associates Medical Group, INC. | Mountain View | California | 94040 | United States |
| California Eye Specialists Medical Group, Inc | Pasadena | California | 91107 | United States |
| Retinal Consultants Medical Group, Inc. | Sacramento | California | 95819 | United States |
| Colorado Retina Associates | Golden | Colorado | 80401 | United States |
| Retina Specialty Institute | Pensacola | Florida | 32503 | United States |
| Retina Vitreous Associates of Florida | St. Petersburg | Florida | 33711 | United States |
| Center for Retina and Macular Disease | Winter Haven | Florida | 33880 | United States |
| Georgia Retina, P.C. | Marietta | Georgia | 30060 | United States |
| Marietta Eye Clinic | Marietta | Georgia | 30060 | United States |
| Gailey Eye Clinic | Bloomington | Illinois | 61704 | United States |
| Raj K. Maturi, MD, PC | Indianapolis | Indiana | 46290 | United States |
| Sabates Eye Center | Leawood | Kansas | 66211 | United States |
| Sierra Eye Associates | Reno | Nevada | 89502 | United States |
| Capital Region Retina, PLLC | Albany | New York | 12206 | United States |
| Ophthalmic Consultants of Long Island | Lynbrook | New York | 11580 | United States |
| Retina Associates of Western New York | Rochester | New York | 14620 | United States |
| Retina Vitreous Surgeons of Central NY, P.C. | Syracuse | New York | 13224 | United States |
| Cincinnati Eye Institute | Cincinnati | Ohio | 45242 | United States |
| Pennsylvania Retina Specialists, P.C. | Camp Hill | Pennsylvania | 17011 | United States |
| Charleston Neuroscience Institute | Ladson | South Carolina | 29456 | United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | United States |
| Retina Research Institute of Texas | Abilene | Texas | 79606 | United States |
| Texas Retina Associates | Arlington | Texas | 76012 | United States |
| Austin Retina Associates | Austin | Texas | 78705 | United States |
| Texan Eye | Austin | Texas | 78731 | United States |
| Retinal Consultants of Houston | Houston | Texas | 77030 | United States |
| Premiere Retina Specialists | Midland | Texas | 79706 | United States |
| Retinal Consultants of San Antonio | San Antonio | Texas | 78240 | United States |
| Retina Consultants of Houston | The Woodlands | Texas | 77384 | United States |
| Strategic Clinical Research Group, LLC | Willow Park | Texas | 76087 | United States |
| Retina Institute of Virginia | Richmond | Virginia | 23235 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Safety Population included all participants who received at least 1 administration of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Best Corrected Visual Acuity (BCVA) | BCVA was measured using an eye chart and reported as number of letters read correctly using Early Treatment of Diabetic Retinopathy Study (ETDRS) Scale (ranging from 0 to 100 letters) in study eye. Lower number of letters read correctly on eye chart, worse the vision (or visual acuity). Study eye: eye that meets entry criteria. If both eyes met entry criteria, eye with worse BCVA at baseline (Day 1) was selected as study eye. If both eyes had same BCVA values at baseline (Day 1), then participant had to select their non-dominant eye for treatment, or else right eye was selected. | Number analyzed is the number of participants with BCVA data available at baseline. | Mean | Standard Deviation | letters |
| |||||||||||||||
| Central Retinal Thickness (CRT) | 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. 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. | Number analyzed is the number of participants with CRT data available at Baseline. | Mean | Standard Deviation | microns |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety Population included all participants who received at least 1 administration of study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (Day 1) to Week 28 |
|
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| |||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | microns | Baseline (Day 1) to Week 28 |
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| ||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | percentage of participants | Baseline (Day 1) to Week 28 |
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| 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. | 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. | Posted | Mean | Standard Deviation | letters | Baseline (Day 1) to Week 28 |
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| 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. | Safety Population included all participants who received at least 1 administration of study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (Day 1), Week 28 |
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| 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] | Not Posted | Baseline to Week 28 | Participants | ||||||||||||||||||||||||||||||||
| Other Pre-specified | Changes From Baseline in General Physical Condition as Measured Through General Physical Exam | Not Posted | Baseline to Week 28 | Participants | ||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Changes From Baseline in Vital Signs (Blood Pressure, Pulse Rate, ECG) | Not Posted | Baseline to Week 28 | Participants | ||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Change From Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis) | Not Posted | Baseline to Week 28 | Participants | ||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Anti-abicipar Antibodies Measured in Serum | Not Posted | Baseline to Week 28 | Participants |
From first dose up to 28 weeks
Safety Population included all participants who received at least 1 administration of study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 2 | 123 | 16 | 123 | 0 | 123 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
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| Tachyarrhythmia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
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| Iritis | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Retinal haemorrhage | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Vitreous haemorrhage | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Vitritis | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
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| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
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| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
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| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
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| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Dysarthria | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
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A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan | 714-246-4500 | IR-CTRegistration@allergan.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 25, 2018 | Jul 17, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C000630582 | abicipar pegol |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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