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
Not provided
Not provided
Not provided
Not provided
This study will evaluate the safety and characterize the systemic pharmacokinetics (PK) of free and vascular endothelial growth factor (VEGF)-bound abicipar following single and multiple intravitreal injections of abicipar pegol in treatment-naïve patients with neovascular age-related macular degeneration (AMD).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abicipar Pegol_Repeat Dose | Experimental | Treatment Group 1: Abicipar pegol 2 mg administered to the study eye by intravitreal injection, 3 injections 4 weeks apart. [Day 1, Weeks 4 and 8] |
|
| Abicipar Pegol_Single Dose | Experimental | Treatment Group 2: Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1. |
|
| 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 | Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12 | |
| Serum Concentration Immediately before Next Dose (Ctrough) for Free and VEGF-Bound Abicipar | Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12 | |
| Time to Cmax (Tmax) for Free and VEGF-Bound Abicipar | Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12 | |
| Terminal Elimination Half-Life (t1/2) for Free and VEGF-Bound Abicipar | Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12 | |
| 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 | Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12 | |
| Area Under the Serum Concentration-Time Curve from Zero to Infinity (AUC0-inf) for Free and VEGF-Bound Abicipar | Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Levels of Anti-abicipar Antibodies | Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12 | |
| Percentage of Participants with Treatment Emergent Adverse Events | Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12 |
Not provided
Inclusion Criteria:
-Presence of active subfoveal and/or juxtafoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Cathy Sutherland | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Consultants of Arizona | Gilbert | Arizona | 85296 | United States | ||
| Win Retina |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Best Corrected Visual Acuity using an Eye Chart | Treatment Group 1: Baseline to Week 20 and Treatment Group 2: Baseline to Week 12 |
| Percentage of Participants with Change from Baseline in Full Ophthalmic Exam Findings [i.e. Slit Lamp Exam, Intraocular Pressure (IOP) Measurements, Funduscopic Exam] | Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12 |
| Changes from Baseline in General Physical Condition as Measured through General Physical Exam | Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12 |
| Percentage of Participants with Changes from Baseline in Vital Signs (Blood Pressure, Pulse Rate) | Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12 |
| Percentage of Participants with Change from Baseline in Clinically Relevant Laboratory Values (Serum Chemistry, Hematology, Urinalysis) | Treatment Group 1: Baseline, Week 20 and Treatment Group 2: Baseline, Week 12 |
| Arcadia |
| California |
| 91006 |
| United States |
| Retina Vitreous Associates Medical Group | Beverly Hills | California | 90211 | United States |
| Atlantis Retina Institute (Atlantis Eyecare) | Huntington Beach | California | 92647 | United States |
| Jacobs Retina Center, Shiley Eye Institute, UCSD | La Jolla | California | 92093 | United States |
| California Eye Specialists Medical Group, Inc-Private Clinic | Pasadena | California | 91107 | United States |
| University of Miami | Coral Gables | Florida | 33146 | United States |
| The Eye Institute of West Florida | Largo | Florida | 33770 | United States |
| Retina Specialty Institute | Pensacola | Florida | 32503 | United States |
| East Florida Eye Insititute | Stuart | Florida | 34994 | United States |
| Center for Retina and Macular Disease | Winter Haven | Florida | 33880 | United States |
| Raj K. Maturi, MD | Indianapolis | Indiana | 46290 | United States |
| Massachusetts Eye & Ear | Boston | Massachusetts | 02114 | United States |
| Eyesight Ophthalmic Services, PA | Portsmouth | New Hampshire | 03801 | United States |
| Caroline Eye Associates | Southern Pines | North Carolina | 28387 | United States |
| Cole Eye Institute, Cleveland Clinic | Cleveland | Ohio | 44122 | United States |
| Rocky Mountain Retina Consultants | Salt Lake City | Utah | 84107 | United States |
| Davis Duehr Dean | Madison | Wisconsin | 53715 | United States |
| 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 |
Not provided
Not provided
Not provided