Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration

Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration - Sequoia Study - Allergan

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43671

Enrollment

Registered

2015-06-22

Start date

2016-04-18

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related macular degeneration AMD

Interventions

Study Treatment Groups and Dosage/Dose Regimen: * Treatment group 2Q8: 2 mg abicipar administered at baseline (D1) and weeks 4 and 8, followed by doses at 8-week intervals through week 96 * Treatment

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - History of vitrectomy, macular surgery, or glaucoma surgery in the study eye - Cataract or refractive surgery in the study eye within the last 3 months

Design outcomes

Primary

Measure	Time frame
Percentage of Patients with Best Corrected Visual Acuity (BCVA) Change from Baseline *15 Letters in the Study Eye at Baseline and Week 52	—

Secondary

Measure	Time frame
* Change from Baseline in BCVA in the Study Eye at Week 52 * Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 52 * Percentage of Patients with a BCVA Gain of 15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale at Week 52 Change from Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score at Week 52	—

Measure

Time frame

* Change from Baseline in BCVA in the Study Eye at Week 52 * Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 52 * Percentage of Patients with a BCVA Gain of *15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale at Week 52 * Change from Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score at Week 52

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)