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| ID | Type | Description | Link |
|---|---|---|---|
| CYPRESS | Other Identifier | Allergan |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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 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. | Baseline, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| 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 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Abicipar Pegol 2 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 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. | Modified Intent-to-Treat (mITT) population included all randomized and treated participants with at least 1 follow-up visit. | Posted | Mean | Standard Deviation | letters | Baseline, Week 16 |
|
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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 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | MedDRA 17.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Registry Team | Allergan, Inc | 1-800-347-4500 | IR-CTRegistration@allergan.com |
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| 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 |
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 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 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. | Baseline, Week 20 |
| 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. | Baseline, Week 20 |
| 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. | Baseline, Week 16, Week 20 |
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.
| 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 |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 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. |
| 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 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. | mITT population included all randomized and treated participants 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 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. | mITT population included all randomized and treated participants with at least 1 follow-up visit. | Posted | Number | percentage of participants | Baseline, Week 20 |
|
|
|
| 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. | mITT population included all randomized and treated participants with at least 1 follow-up visit. | Posted | Number | percentage of participants | Baseline, Week 20 |
|
|
|
| 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. | mITT population included all randomized and treated participants with at least 1 follow-up visit. | Posted | Mean | Standard Deviation | microns | Baseline, Week 16, Week 20 |
|
|
|
| 1 |
| 10 |
| 5 |
| 10 |
| EG001 | 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. | 1 | 10 | 6 | 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. | 0 | 5 | 2 | 5 |
| Escherichia bacteremia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Drug hypersensitivity | Immune system disorders | MedDRA 17.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Retinal vein occlusion | Eye disorders | MedDRA 17.1 | Systematic Assessment |
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| Uveitis | Eye disorders | MedDRA 17.1 | Systematic Assessment |
|
| Vitritis | Eye disorders | MedDRA 17.1 | Systematic Assessment |
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| Iridocyclitis | Eye disorders | MedDRA 17.1 | Systematic Assessment |
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| Punctate keratitis | Eye disorders | MedDRA 17.1 | Systematic Assessment |
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| Retinal haemorrhage | Eye disorders | MedDRA 17.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Visual acuity reduced | Eye disorders | MedDRA 17.1 | Systematic Assessment |
|
| Aortic stenosis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
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| Conjunctival haemorrhage | Eye disorders | MedDRA 17.1 | Systematic Assessment |
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| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Tricuspid valve incompetence | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
|
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.
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
|
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| Change from Baseline at Week 20 |
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