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Abicipar pegol · 8 trials · 2 indications
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 2 mg (group A) | EXPERIMENTAL | Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, and 20, followed by a sham procedure at weeks 12, 16, and 24. |
| abicipar pegol 2 mg (group B) | EXPERIMENTAL | Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, 16, and 24, followed by a sham procedure at weeks 12 and 20. |
| ranibizumab | ACTIVE_COMPARATOR | Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24. |
| 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...
Abicipar pegol is an investigational small molecule being developed for the treatment of macular degeneration and macular edema. It is currently in Phase 3 clinical development for these ophthalmologic conditions. The drug is administered via intravitreal injection and has been studied in patients with neovascular age-related macular degeneration and diabetic macular edema.
Abicipar pegol is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for the treatment of macular degeneration and macular edema.
Abicipar pegol is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The drug has completed seven clinical trials, including Phase 1 and Phase 2 studies, and is currently being evaluated in later-stage trials for the treatment of macular degeneration and macular edema.
Abicipar pegol has been studied in seven completed clinical trials. Notable trials include NCT02186119, a Phase 2 study in patients with diabetic macular edema; NCT02859766, a Phase 1 study in patients with neovascular AMD; NCT03335852, a Phase 1 study in Japanese patients with neovascular AMD; and NCT03539549, a Phase 2 study in patients with neovascular age-related macular degeneration.
Abicipar pegol is administered via intravitreal injection, meaning it is injected directly into the vitreous humor of the eye. This route of administration is commonly used for ophthalmologic drugs targeting retinal conditions. The drug has been evaluated in clinical trials with patients aged 19 years and older, depending on the specific study protocol.
Abicipar pegol is a distinct investigational drug and is not known to be the same as any other approved medication. It is a small molecule being developed specifically for the treatment of macular degeneration and macular edema. Its unique mechanism and formulation differentiate it from other therapies in the ophthalmology space.