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Monoclonal Antibodies

Customized treatment interval for Age-Related Macular Degeneration (XPAND Trial)

Phase 4
Waitlist Available
Research Sponsored by Bayer
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 at week 36 and week 52
Awards & highlights

XPAND Trial Summary

This trialwill study whether extending treatment intervals faster than standard T&E can maintain eye health and improve vision in patients with wet AMD.

Eligible Conditions
  • Age-Related Macular Degeneration (AMD)

XPAND Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 36 and week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 36 and week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in best-corrected visual acuity (BCVA)
Number of IVT aflibercept injections per patient
Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
+1 more

Side effects data

From 2020 Phase 4 trial • 26 Patients • NCT03022292
4%
Retinal detachment
4%
Myelodysplastic syndrome
4%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
IAI Treatment

XPAND Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Customized treatment intervalExperimental Treatment1 Intervention
After the initial study injection at baseline, participants will receive their next study injection at Week 16. Participants in this study arm will also be issued a home monitoring device, which will allow for regular OCT monitoring (at least 5 times a week) at home.
Group II: Treat and extend (T&E) 2 week adjustmentActive Control1 Intervention
Participants will receive treatment in intervals maintained (8 weeks) or adjusted in 2 weeks increments each time (up to a maximum of 16 weeks and minimum of 4 weeks), as long as all extension/shortening criteria are met.

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsIndustry Sponsor
616 Previous Clinical Trials
379,842 Total Patients Enrolled
BayerLead Sponsor
2,237 Previous Clinical Trials
25,326,975 Total Patients Enrolled

Frequently Asked Questions

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

Are individuals with qualifying conditions still able to partake in this research?

"This particular clinical trial is not actively recruiting, as the latest edit on its listing was made on November 2nd 2022. Nonetheless, there are still 159 other research trials that require volunteers."

Answered by AI

How numerous are the sites where this research can be accessed?

"There are 6 sites to choose from, such as Sunnybrook Health Sciences Center Ophthalmology in Toronto, St Joseph's Health Care London - Ivey Eye Institute in London and GOGiunta ophtalmologie in Sherbrooke. There are also 3 other medical centres participating."

Answered by AI

Has the FDA sanctioned a specific period of treatment for Customized therapy?

"Due to the fact that Customized treatment interval is a Phase 4 trial, it has been assigned a safety score of 3 on our organization's scale. This suggests that this therapy has already gained approval from regulatory bodies."

Answered by AI

Who else is applying?

What state do they live in?
Ontario
What site did they apply to?
Sunnybrook Health Sciences Center Ophthalmology
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

How long will screening take? What are my chances of getting selected?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

To take preventative measures to ensure that either my AMD gets treated or progression delayed, to enable me to live an independent life.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Learn How Well Aflibercept Injected Into the Eye Works and How Safe it is When Given in Customized Treatment Intervals in Patients With an Eye Disease Called Neovascular Age-related Macular Degeneration After Start of Treatment
2023. "A Study to Learn How Well Aflibercept Injected Into the Eye Works and How Safe it is When Given in Customized Treatment Intervals in Patients With an Eye Disease Called Neovascular Age-related Macular Degeneration After Start of Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05473715.
~1 spots leftby Apr 2025
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