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Monoclonal Antibodies

ABP 938 for Age-Related Macular Degeneration

Phase 3
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Central retinal thickness of > 270µm in the study eye as measured by the machine, calculated average thickness in the central 1 mm subfield (CST) by SD-OCT at screening
Subjects or their legally authorized representative must sign an Institutional Review Board/Independent Ethics Committee approved informed consent form before any study-specific procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and weeks 4, 8, 16, 24, 32, 40, 48, and 52
Awards & highlights

Study Summary

This trial will compare the effectiveness of two drugs in treating age-related macular degeneration.

Eligible Conditions
  • Age-Related Macular Degeneration (AMD)

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and weeks 4, 8, 16, 24, 32, 40, 48, and 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and weeks 4, 8, 16, 24, 32, 40, 48, and 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Change From Baseline in BCVA at Week 8
Secondary outcome measures
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 more

Side effects data

From 2023 Phase 3 trial • 576 Patients • NCT04270747
4%
Conjunctival haemorrhage
1%
COVID-19
1%
Neovascular age-related macular degeneration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Through Week 16: Aflibercept
Post Week 16: ABP 938 / ABP 938
Through Week 16: ABP 938
Post Week 16: Aflibercept / ABP 938
Post Week 16: Aflibercept / Aflibercept

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
301 Previous Clinical Trials
100,064 Total Patients Enrolled
AmgenLead Sponsor
1,355 Previous Clinical Trials
1,383,495 Total Patients Enrolled
MDStudy DirectorAmgen
899 Previous Clinical Trials
921,172 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what purpose is ABP 938 typically employed?

"ABP 938 is a medication commonly prescribed to patients with wet age-related macular degeneration (wamd). This drug can also be used to mitigate macular edema, diabetic macular edema (dme), and other forms of macular degeneration."

Answered by AI

What is the ABP 938 drug's official classification?

"ABP 938 has been given a safety rating of 3. This is due to it being a Phase 3 trial, where there is evidence of its efficacy as well as multiple rounds of data affirming its safety."

Answered by AI

Could you please describe other similar medical studies to ABP 938?

"M D Anderson Cancer Center conducted the first study on ABP 938 in 2014. As of now, there have been a total of 231 completed trials. At the moment, there are 49 active studies, a majority of which are taking place in San Antonio and New york."

Answered by AI

Are there different test sites for this clinical trial in the United States?

"So far, 53 different locations have been approved to operate for this study. These include Retina Associates of South Texas, P.A. in San Antonio, Ophthalmic Consultants of the Capital Region - Ophthalmology in Troy, and Colorado Retina Associates - Porter Hospital in Lakewood."

Answered by AI

If a patient wanted to enroll in this clinical trial, could they?

"This clinical trial is not recruiting at the moment, but was last edited on 11/1/2022. There are 169 other trials for glycogen storage disease type ii and 49 for ABP 938 that are actively recruiting patients if you are interested."

Answered by AI

How many people are you looking for to enroll in this trial?

"As of now, this clinical study is not admitting any new patients. The trial was first posted on June 22nd, 2020 and was last updated on November 1st, 2022. However, there are 169 other trials for glycogen storage disease type ii and 49 trials for ABP 938 that are currently looking for participants."

Answered by AI
~121 spots leftby Mar 2025