Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| BAMBOO | Other Identifier | Allergan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| abicipar pegol 2 mg | Experimental | 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. |
|
| abicipar pegol 1 mg | Experimental | 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. |
|
| ranibizumab 0.5 mg | Active Comparator | Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| abicipar pegol | Drug | Abicipar pegol administered to the study eye by intravitreal injection at day 1, weeks 4 and 8. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nihon University Hospital | Chiyoda-ku,Tokyo | 101-8309 | Japan | |||
| 1 Fukushima Medical University |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Abicipar Pegol 1 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | Modified Intent-to-Treat: all randomized and treated patients with at least 1 follow-up visit | Posted | Mean | Standard Deviation | Letters | Baseline, Week 16 |
|
Not provided
The Safety Population included all enrolled patients and is used to assess adverse events and serious adverse events.
Not provided
| 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 at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iritis | Eye disorders | MedDRA 18.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
Not provided
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000630582 | abicipar pegol |
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ranibizumab | Drug | Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16. |
|
|
| sham procedure | Other | Sham procedure to the study eye at weeks 12 and 16. |
|
| Baseline, Week 20 |
| 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. | Baseline, 20 Weeks |
| 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. | Baseline, 20 Weeks |
| 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. | Baseline, Week 16, Week 20 |
| Fukushima |
| 960-1295 |
| Japan |
| Kyushu University Hospital | Kita-ku, Fukuoka-shi Fukuoka | 812-8582 | Japan |
| Okayama University Hospital | Kita-ku, Okayama-shi Okayama | 700-8558 | Japan |
| Shiga University | Ōtsu | 520-2192 | Japan |
| Tokyo Women's Medical University | Shinjuku-ku | 162-8666 | Japan |
| Nagoya University Hospital | Showa-ku, Nagoya-shi Aichi | 466-8560 | Japan |
| Takeuchi Eye Clinic | Taito Ku Tokyo | 111-0051 | Japan |
| Musashi Dream Clinic | Tennoji-ku Osaka | 543-0027 | Japan |
| Juntendo University Urayas | Urayasu-shi | 279-0021 | Japan |
| Otakeganka Tsukimino Clinic | Yamato Kanagawa | 242-0001 | Japan |
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.
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 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. |
| OG002 | 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. |
|
|
| 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. | Modified Intent-to-Treat: all randomized and treated patients with at least 1 follow-up visit | Posted | Mean | Standard Deviation | Letters | Baseline, Week 20 |
|
|
|
| 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. | Modified Intent-to-Treat: all randomized and treated patients with at least 1 follow-up visit | Posted | Number | Percentage of Patients | Baseline, 20 Weeks |
|
|
|
| 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. | Modified Intent-to-Treat: all randomized and treated patients with at least 1 follow-up visit | Posted | Number | Percentage of Patients | Baseline, 20 Weeks |
|
|
|
| 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. | Modified Intent-to-Treat: all randomized and treated patients with at least 1 follow-up visit | Posted | Mean | Standard Deviation | microns | Baseline, Week 16, Week 20 |
|
|
|
| 0 |
| 10 |
| 4 |
| 10 |
| EG001 | 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. | 0 | 10 | 8 | 10 |
| EG002 | 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. | 2 | 5 | 5 | 5 |
| Angle closure glaucoma | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Embolic stroke | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Vitreous opacities | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Foreign body sensation in eyes | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Anterior chamber inflammation | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Asthenopia | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Device breakage | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Eosinophil count increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Periodontitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Vitritis | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Retinal exudates | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
If the site intends to publish the Clinical Trial results and other information with an academic intention, or Allergan intends to utilize the related information for distribution activities of its own, the said party must obtain the consent from the other party in advance. However, except for the case based on the due reason including that the consent of trial subjects cannot be obtained though it is mandatory, the other party cannot refuse the consent.
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
|
|
| Change from Baseline at Week 20 |
|