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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01397409 | Evaluation of AGN-150998 in Exudative Age-related Macular Degeneration (AMD) | PHASE2 | COMPLETED | 271 | — | — | Sep 1, 2011 | Apr 30, 2014 | Apr 16, 2019 | 8 | United States, Australia +6 |
Stage 1 evaluated the safety of a single intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.
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.
Recurrence of Active Disease was based on Best Corrected Visual Acuity (BCVA), Central Retinal Thickness (CRT) values as evaluated by the Central Reading Center (CRC) and the investigator assessments of haemorrhage.
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 in the number of letters read correctly means that vision has improved.
| Arm | Type | Description |
|---|---|---|
| Stage 1: AGN-150998 4.2 mg | EXPERIMENTAL | Stage 1: AGN-150998 4.2.mg given as a single intravitreal injection. |
| Stage 1: AGN-150998 3.0 mg | EXPERIMENTAL | Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection. |
| Stage 1: AGN-150998 2.0 mg | EXPERIMENTAL | Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection. |
| Stage 1: AGN-150998 1.0 mg | EXPERIMENTAL | Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection. |
| Stage 2: AGN-150998 4.2 mg | EXPERIMENTAL | Stage 2: AGN-150998 4,2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16. |
| Stage 2: AGN-150998 3.0 mg | EXPERIMENTAL | Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose) from Stage 1 given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16. |
| Stage 2: ranibizumab 0.5 mg | ACTIVE_COMPARATOR | Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16. |
| Stage 3: AGN-150998 2.0 mg | EXPERIMENTAL | Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16. |
| Stage 3: AGN-150998 1.0 mg | EXPERIMENTAL | Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16. |
| Stage 3: ranibizumab 0.5 mg | ACTIVE_COMPARATOR | Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks. |
| Name | Type | Description |
|---|---|---|
| AGN-150998 | DRUG | AGN-150998 Intravitreal injection. |
| ranibizumab | DRUG | Ranibizumab 0.5 mg given by intravitreal injection. |
| Sham Injection | OTHER | Stage 3: Sham injection at Weeks 12 and 16. |
Inclusion Criteria: * Exudative age-related macular degeneration * Best-corrected visual acuity between 20/32 and 20/320 in the study eye Exclusion Criteria: * Near-sightedness of 8 diopters or more * Uncontrolled glaucoma in the study eye * Cataract surgery or Lasik within the last 3 months * An...