Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02462486 | Safety and Efficacy of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration | PHASE3 | COMPLETED | 949 | — | — | Jun 25, 2015 | Jun 6, 2019 | Jul 30, 2020 | 187 | United States, Australia +14 |
| NCT02462928 | A Safety and Efficacy Study of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration | PHASE3 | COMPLETED | 939 | — | — | Jun 25, 2015 | Jun 19, 2019 | Jul 28, 2020 | 151 | United States, Argentina +15 |
| NCT03539549 | A Study to Evaluate Abicipar Pegol for Safety and Treatment Effect in Participants With Neovascular Age-related Macular Degeneration (AMD) | PHASE2 | COMPLETED | 124 | — | — | May 25, 2018 | Feb 27, 2019 | Aug 3, 2020 | 37 | United States |
| NCT02181504 | A Study of Abicipar Pegol in Japanese Patients With Neovascular Age-related Macular Degeneration | PHASE2 | COMPLETED | 25 | — | — | Sep 1, 2014 | Dec 1, 2015 | Apr 25, 2017 | 11 | Japan |
| NCT02181517 | A Study of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration | PHASE2 | COMPLETED | 25 | — | — | Jul 1, 2014 | Mar 1, 2015 | May 17, 2016 | 1 | United States |
| NCT03335852 | Safety and Pharmacokinetics of Abicipar Pegol Intravitreal Injections in Japanese Patients With Neovascular AMD | PHASE1 | COMPLETED | 11 | — | — | Nov 28, 2017 | Oct 8, 2018 | Nov 1, 2018 | 5 | Japan |
| NCT02859766 | Safety and Pharmacokinetics of Abicipar Pegol Intravitreal Injections in Patients With Neovascular AMD | PHASE1 | COMPLETED | 30 | — | — | Dec 7, 2016 | Oct 20, 2017 | Feb 8, 2018 | 18 | United States |
Stable vision was defined as vision loss of fewer than 15 letters in Best-corrected Visual Acuity (BCVA) from baseline. 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 participants with a BCVA loss of fewer than 15 letters are reported. Study eye was defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Abicipar Pegol 2 mg (2Q8) | EXPERIMENTAL | Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 8, followed by injections every 8 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered. |
| Abicipar Pegol 2 mg (2Q12) | EXPERIMENTAL | Abicipar pegol 2 mg was administered to the study eye by intravitreal injection on Day 1, Week 4, and Week 12, followed by injections every 12 weeks through Week 96. Scheduled visits occurred every 4 weeks. To maintain masking, sham was administered to the study eye at scheduled visits where abicipar was not administered. |
| Ranibizumab (rQ4) | ACTIVE_COMPARATOR | Ranibizumab (Lucentis®) was administered to the study eye by intravitreal injection every 4 weeks from Day 1 through Week 96. |
| Ranibizumab 0.5 mg (rQ4) | ACTIVE_COMPARATOR | Ranibizumab (Lucentis®) 0.5 mg was administered to the study eye by intravitreal injection every 4 weeks (rQ4) from Day 1 through Week 96. |
| 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. |
| 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. |
| Abicipar pegol | EXPERIMENTAL | Abicipar pegol 2 mg administered to the study eye by intravitreal injection |
| 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 |
|---|---|---|
| Abicipar Pegol | DRUG | Abicipar pegol intravitreal injection. |
| Ranibizumab | DRUG | Ranibizumab intravitreal injection. |
| Sham Procedure | OTHER | Sham injection. |
Inclusion Criteria: * Diagnosis of age-related macular degeneration in at least 1 eye * Best corrected visual acuity of 20/40 to 20/320 in the study eye * Best corrected visual acuity of 20/200 or better in the non-study eye Exclusion Criteria: * History of vitrectomy, macular surgery, or glaucom...