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Monoclonal Antibodies

ABP 938 for Chorioretinal Vascular Disease

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
Men or women ≥18 years old.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 35 days
Awards & highlights

Study Summary

This trial studies the accuracy of eye injections with a new drug, ABP 938, compared to an existing drug, aflibercept.

Eligible Conditions
  • Chorioretinal Vascular Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are 18 years old or older, regardless of gender.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 35 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 35 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Successful IVT Injections Utilizing aflibercept
Proportion of Successful IVT Injections Utilizing ABP 938
Secondary outcome measures
Number of Non-ocular SAEs
Number of Ocular Adverse Events (AEs)
Number of Serious Adverse Events (SAEs) in the Study Eye

Trial Design

2Treatment groups
Experimental Treatment
Group I: AfliberceptExperimental Treatment1 Intervention
Participants will be randomized in a ratio of 2:1 to receive either a single IVT injection of ABP 938 in a PFS or a single injection of aflibercept in a PFS.
Group II: ABP 938Experimental Treatment1 Intervention
Participants will be randomized in a ratio of 2:1 to receive either a single IVT injection of ABP 938 in a PFS or a single injection of aflibercept in a PFS.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABP 938
2023
Completed Phase 3
~630
Aflibercept
2016
Completed Phase 4
~2540

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,355 Previous Clinical Trials
1,384,022 Total Patients Enrolled
MDStudy DirectorAmgen
899 Previous Clinical Trials
921,699 Total Patients Enrolled

Frequently Asked Questions

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

Is there an upper age limit for potential participants in this research?

"As per the eligibility requirements for this trial, the age range accepted is 18 to 99."

Answered by AI

What safety precautions are necessary when administering ABP 938 to patients?

"We rate ABP 938's safety at a 3 on the scale of 1-3 due to its Phase 3 status and evidence both for efficacy and multiple rounds of data proving its security."

Answered by AI

Are there currently any vacancies in this experiment for volunteers?

"Per clinicaltrials.gov, the trial that was initially posted on 1/23/2023 is currently recruiting participants. This information has been recently updated as of 2/10/2023."

Answered by AI

What is the current tally of facilities conducting this clinical trial?

"There are 4 clinical trial sites that have begun recruiting patients, such as the Bellaire Retina Center in Texas, San Antonio's Retina Centre and The Woodlands' Retinal Consultants of Texas."

Answered by AI

How many participants are currently enrolled in this research initiative?

"Affirmative. According to the clinicaltrials.gov portal, this medical trial is searching for 48 participants across 4 sites and was initially posted on January 23rd 2023 with a later update occurring on February 10th of that same year."

Answered by AI

What are the eligibility requirements for participation in this trial?

"The study requires 48 individuals who have chorioretinal vascular disease and are between 18-99 years of age. The key criteria for applicants include signing an approved informed consent form, being male or female over the age of eighteen, and having neovascular age-related macular degeneration, diabetic macular edema, macular edema due to retinal vein occlusion or diabetic retinopathy in one eye (with treatment not necessary)."

Answered by AI
~23 spots leftby Mar 2025