NCT07891182

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
18mo left

Started Dec 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 23, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

October 23, 2026

Status Verified

October 1, 2026

Enrollment Period

1.5 years

First QC Date

October 14, 2026

Last Update Submit

October 14, 2026

Conditions

Glaucoma

Keywords

glaucomaglaucoma drainage implantglaucoma tube shuntAhmed glaucoma valveintravitreal injectionaflibercept

Outcome Measures

Primary Outcomes (1)

  • Intraocular pressure

    Intraocular pressure (IOP) measured by Goldmann applanation tonometry and reported in millimeters of mercury (mmHg). IOP represents the pressure within the eye and is assessed at each scheduled postoperative follow-up visit.

    Postoperative day 1, week 1, month 1, month 2, and month 3

Secondary Outcomes (4)

  • Surgical failure

    up to 6 months

  • Medication Burden

    Postoperative day 1, week 1, month 1, month 2, month 3, and month 6

  • Hypertensive phase

    Up to 3 months

  • Treatment adverse events and serious treatment adverse events

    Up to 6 months

Study Arms (2)

Ahmed Tube Surgery with Aflibercept Intravitreal Injection Group

EXPERIMENTAL

Participants will undergo standard of care Ahmed tube surgery and will receive one 8 mg injection of intravitreal aflibercept at three timepoints in the study: at the conclusion of surgery, Postoperative Month 1, Postoperative Month 2. Total duration of participation in this arm is 6 months

Drug: Aflibercept InjectionProcedure: Ahmed Tube Surgery

Ahmed Tube Surgery without Perioperative Aflibercept (Control Group)

ACTIVE COMPARATOR

Participants will undergo standard of care Ahmed tube surgery without any injections of intravitreal aflibercept. Total duration of participation in this arm is 6 months.

Procedure: Ahmed Tube Surgery

Interventions

Aflibercept InjectionDRUG

Aflibercept 8 mg will be administered intravitreally at three time points: immediately after Ahmed tube surgery, at postoperative month 1, and at postoperative month 2.

Also known as: Eylea
Ahmed Tube Surgery with Aflibercept Intravitreal Injection Group
Ahmed Tube SurgeryPROCEDURE

Participants will receive standard of care Ahmed tube surgery.

Ahmed Tube Surgery with Aflibercept Intravitreal Injection GroupAhmed Tube Surgery without Perioperative Aflibercept (Control Group)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 85 years, inclusive.
  • Open-angle glaucoma (primary or secondary such as pseudoexfoliative, pigmentary, steroid response) that is inadequately controlled on tolerated medical therapy with intraocular pressure greater than or equal to 18 mm Hg and less than or equal to 40 mm Hg.

You may not qualify if:

  • Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits.
  • No light perception vision.
  • Prior aqueous shunt or cyclodestructive procedure.
  • Prior exposure to anti-VEGF in either eye.
  • Diabetic retinopathy.
  • Wet age-related macular degeneration.
  • Retinal vein occlusion.
  • Choroidal neovascular membrane.
  • History of cystoid macular edema.
  • Vitreous prolapse.
  • Previous or active ocular neovascularization.
  • Iridocorneal endothelial syndrome.
  • Epithelial or fibrous downgrowth.
  • Chronic or recurrent uveitis, or acute uveitis within 90 days of surgery.
  • Use of topical steroids within 30 days of surgery.
  • +26 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Glaucoma

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Adam Rothman, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam Rothman, MD

CONTACT

954-465-2700alr235@med.miami.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical Ophthalmology

Study Record Dates

First Submitted

October 14, 2026

First Posted

October 23, 2026

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

October 23, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)