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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and weeks 4, 8, 16, 24, 32, 40, 48, and 52
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial compares two drugs, ABP 938 and Aflibercept, for treating patients with a serious eye condition called neovascular age-related macular degeneration. The drugs are injected into the eye to stop harmful blood vessel growth and protect vision. Aflibercept is designed to target specific growth factors involved in this condition.
Eligible Conditions
- Wet AMD
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and weeks 4, 8, 16, 24, 32, 40, 48, and 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and weeks 4, 8, 16, 24, 32, 40, 48, and 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean Change From Baseline in BCVA at Week 8
Secondary study objectives
Mean Change From Baseline in BCVA
Mean Change From Baseline in Central Subfield Thickness (CST)
Mean Change From Baseline in Choroidal Neovascularization (CNV) Area Size
+5 moreSide effects data
From 2023 Phase 3 trial • 576 Patients • NCT042707478%
Neovascular age-related macular degeneration
6%
Conjunctival haemorrhage
1%
Ankle fracture
1%
Visual acuity reduced
1%
Arthropod-borne disease
1%
Acute respiratory failure
1%
Retinal haemorrhage
1%
Haemarthrosis
1%
Visual impairment
1%
Small intestinal obstruction
1%
Cholangitis acute
1%
Atrial fibrillation
1%
Lung neoplasm malignant
100%
80%
60%
40%
20%
0%
Study treatment Arm
Post Week 16: Aflibercept / Aflibercept
Through Week 16: Aflibercept
Post Week 16: Aflibercept / ABP 938
Post Week 16: ABP 938 / ABP 938
Through Week 16: ABP 938
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: ABP 938-Treatment Group AExperimental Treatment1 Intervention
Subjects will receive 2 mg (0.05 mL) of ABP 938 by intravitreal (IVT) injection every 4 weeks for the first 3 doses (ie, baseline/day 1, week 4, and week 8) and every 8 weeks from week 16 until week 48.
Group II: ABP 938-Treatment group B2Active Control2 Interventions
Subjects will receive 2 mg (0.05 mL) of aflibercept (Treatment Group B) by IVT injection every 4 weeks for the first 3 doses (ie, baseline/day 1, week 4, and week 8). Subjects will be re-randomized to receive ABP 938 by IVT injection every 8 weeks from week 16 until week 48
Group III: Aflibercept-Treatment Group B1Active Control1 Intervention
Subjects will receive 2 mg (0.05 mL) of aflibercept (Treatment Group B) by IVT injection every 4 weeks for the first 3 doses (ie, baseline/day 1, week 4, and week 8). Subjects will be re-randomized to receive aflibercept by IVT injection every 8 weeks from week 16 until week 48.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABP 938
2023
Completed Phase 3
~630
Find a Location
Who is running the clinical trial?
ParexelIndustry Sponsor
311 Previous Clinical Trials
100,873 Total Patients Enrolled
AmgenLead Sponsor
1,431 Previous Clinical Trials
1,384,589 Total Patients Enrolled
MDStudy DirectorAmgen
970 Previous Clinical Trials
928,887 Total Patients Enrolled
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