Aflibercept + Ahmed Tube Surgery for Glaucoma

AR
Overseen ByAdam Rothman, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Miami
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to determine if injections of aflibercept into the eye given at the end of the Ahmed tube surgery as well as at postoperative months one and two would improve eye pressure control compared to standard surgery with no aflibercept.

Who Is on the Research Team?

AR

Adam Rothman, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for people with glaucoma who are scheduled to have Ahmed tube surgery. Participants should not have conditions or factors that would prevent them from safely receiving eye injections or undergoing this type of eye surgery.

Inclusion Criteria

I am between 18 and 85 years old.
I have open-angle glaucoma that is not well controlled with my current medications.

Exclusion Criteria

I have eye scarring that prevents Ahmed implant surgery in the preferred area.
I have no vision and cannot perceive any light.
I have used topical steroids in the last 30 days before surgery.
See 33 more

What Are the Treatments Tested in This Trial?

Interventions

  • Aflibercept Injection
  • Ahmed Tube Surgery

Trial Overview

The study compares standard Ahmed tube surgery alone versus the same surgery plus aflibercept injections into the eye, given during and after the operation, to see if it better controls eye pressure.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Ahmed Tube Surgery with Aflibercept Intravitreal Injection GroupExperimental Treatment2 Interventions
Group II: Ahmed Tube Surgery without Perioperative Aflibercept (Control Group)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

Regeneron Pharmaceuticals

Industry Sponsor

Trials
690
Recruited
948,000+
Founded
1988
Headquarters
Tarrytown, USA
Known For
Precision medicine
Top Products
Dupixent, EYLEA, Libtayo, Praluent
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Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

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George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School