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Monoclonal Antibodies

Aflibercept for Age-Related Macular Degeneration

Phase 3

Waitlist Available

Research Sponsored by Michel Giunta

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 from baseline to week 52 (month 12)

Awards & highlights

Study Summary

This trial is comparing two ways of giving the drug aflibercept to people with wet age-related macular degeneration, to see if one is better than the other at preserving patients' vision.

Eligible Conditions

Wet Age-related Macular Degeneration

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to week 52 (month 12)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to week 52 (month 12)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 52 (month 12) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Best Corrected Visual Acuity

Injections

Secondary outcome measures

Gain of letters

Loss of letters

Therapeutic procedure

Side effects data

From 2015 Phase 4 trial • 26 Patients • NCT01617148

Cataract progression

100%

80%

60%

40%

20%

Study treatment Arm

Single Group

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treat and ExtendExperimental Treatment1 Intervention

2 ml (40 mg/ml) of Eylea solution : loading dose of 3 intravitreal injections every 4 weeks for the first 3 months followed and, until the end of the study, retreatment interval based on disease stability

Group II: StandardActive Control1 Intervention

2 ml (40 mg/ml) of Eylea solution : loading dose of 3 intravitreal injections every 4 weeks for the first 3 months followed by an injection every 8 weeks until the end of the study

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aflibercept

2016

Completed Phase 4

~2540

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Michel GiuntaLead Sponsor

BayerIndustry Sponsor

2,239 Previous Clinical Trials

25,332,688 Total Patients Enrolled

Frequently Asked Questions

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

When will this clinical trial reach its full-scale potential?

"This study is not actively recruiting patients. The listing was first posted on July 24th, 2019 and has had its most recent update on June 13th, 2022. There are presently 168 clinical trials actively searching for participants with age related macular degeneration and 51 studies for Aflibercept actively searching for participants."

Answered by AI

What is Aflibercept used to manage?

"Aflibercept is a medication used to treat wet age-related macular degeneration (WAMD), as well as other retinal conditions such as macular edema, diabetic macular edema (DME), and generalised macular degeneration."

Answered by AI

Has Aflibercept gone through the FDA's regulatory process?

"Our team at Power has estimated that Aflibercept is safe to use, scoring it a 3 on a scale of 1 to 3. This is because there is some data supporting its efficacy and multiple rounds of data supporting its safety."

Answered by AI

Are we enrolling patients in this clinical trial right now?

"This particular clinical trial has already closed recruitment. The study was first posted on July 24th, 2019 and its last update was June 13th, 2022. However, if the reader is interested in other trials, there are currently 168 studies enrolling patients with age related macular degeneration and 51 trials for Aflibercept that are still open."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treat and Extend Analysis Trial With Aflibercept in Wet-AMD

Michel Giunta 2019. "Treat and Extend Analysis Trial With Aflibercept in Wet-AMD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04113538.