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AGN-150998 · 1 trial · 1 indication
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...
AGN-150998 is an investigational small molecule being developed for the treatment of age-related macular degeneration (AMD), a condition that affects the central part of the retina and can lead to vision loss. It is currently in Phase 2 clinical development.
AGN-150998 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The drug is in Phase 2 clinical development for age-related macular degeneration.
AGN-150998 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in patients with age-related macular degeneration.
AGN-150998 has one completed Phase 2 clinical trial, identified as NCT01397409, which evaluated the drug in exudative age-related macular degeneration. The trial enrolled 271 participants across multiple countries, including the United States, Australia, and several European nations.
No alternative names for AGN-150998 have been reported. It is identified by its code name AGN-150998 in clinical trials and is being developed by AbbVie Inc. for age-related macular degeneration.