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This study will evaluate the safety and to characterize the systemic pharmacokinetics of free and vascular endothelial growth factor (VEGF)-bound abicipar following multiple monthly intravitreal injections of abicipar in Japanese patients with neovascular age-related macular degeneration (AMD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abicipar pegol | Experimental | Abicipar pegol 2 mg administered to the study eye by intravitreal injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abicipar pegol | Drug | Abicipar pegol 2 mg administered to the study eye by intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Serum Concentration (CMax) for Free and VEGF-Bound Abicipar | Baseline to Week 20 | |
| Serum Concentration Immediately before Next Dose (Ctrough) for Free and VEGF-Bound Abicipar | Baseline to Week 20 | |
| Time to Cmax (Tmax) for Free and VEGF-Bound Abicipar | Baseline to Week 20 | |
| Terminal Elimination Half-Life (t1/2) for Free and VEGF-Bound Abicipar | Baseline to Week 20 | |
| Area Under the Serum Concentration-Time Curve from Zero to the End of the Dosing Interval "tau" (AUC0-tau) for Free and VEGF-Bound Abicipar | Baseline to Week 20 | |
| Area Under the Serum Concentration-Time Curve from Zero to Infinity (AUC0-inf) for Free and VEGF-Bound Abicipar | Baseline to Week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Levels of Anti-abicipar Antibodies | Baseline to Week 20 | |
| Percentage of Participants with Treatment Emergent Adverse Events | Baseline to Week 20 | |
| Best Corrected Visual Acuity using an Eye Chart |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cathy Sutherland | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kimura Eye and Internal Medicine Hospital | Kure | Hiroshima | 737-0029 | Japan | ||
| Musashi Dream Clinic |
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| Label | URL |
|---|---|
| Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance. | View source |
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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 |
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| Baseline to Week 20 |
| 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 20 |
| Changes from Baseline in General Physical Condition as Measured through General Physical Exam | Baseline to Week 20 |
| Percentage of Participants with Changes from Baseline in Vital Signs (Blood Pressure, Pulse Rate, ECG) | Baseline to Week 20 |
| Percentage of Participants with Change from Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis) | Baseline to Week 20 |
| Tennouji-ku |
| Osaka |
| 543-0027 |
| Japan |
| Takeuchi Eye Clinic | Taito-ku | Tokyo | 111-0051 | Japan |
| Souseikai Hakata Clinic | Fukuoka | 812-0025 | Japan |
| Fukushima Medical University Hospital | Fukushima | 960-1295 | Japan |