GlaucomaPhase 2NCT07891182
VGFTe-(HD)-OD-2566: Adjunctive Aflibercept Ahmed Glaucoma Valve (AAA) Study
A Phase 2 study testing Aflibercept Injection and Ahmed Tube Surgery in people with Glaucoma, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Aflibercept Injection and Ahmed Tube Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Jun 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Conjunctival scarring sufficient to preclude Ahmed implantation in preferred quadrant.
- Scleral buckle.
- Severe posterior blepharitis.
- Aphakia.
- Unwilling to discontinue contact lens use after surgery.
- Need for glaucoma surgery combined with other ocular procedures (i.e. cataract surgery, penetrating keratoplasty, or retinal surgery) or anticipated need for additional ocular surgery.
- Best corrected visual acuity 20/200 or worse in fellow eye.
- Uncontrolled blood pressure (systolic blood pressure >165 mmHg or diastolic blood pressure >95 mmHg) or the investigator is concerned would have unstable blood pressure during the course of the study, such as due to compliance issues.
- History of cerebrovascular accident or myocardial infarction within 180 days of surgery.
- Hemodialysis and/or history of renal transplant
- Known history of sensitivity to any compounds of the study formulation
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of aflibercept 8 mg or that might affect interpretation of the results of the study or render the patient at high risk for treatment complications
- Participation in an investigational study within 30 days prior to screening visit that involved treatment with any drug (excluding vitamins and minerals) or device
- Pregnant or nursing women.
- Men or women of childbearing potential (WOCBP)* who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 3 months after the last dose.
- Highly effective contraceptive measures include:
- stable use of combined (estrogen and progestogen-containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening
- intrauterine device (IUD); intrauterine hormone-releasing system (IUS)
- bilateral tubal ligation
- vasectomy
- condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly
- and/or sexual abstinence
- Postmenopausal women must be amenorrhoeic for at least 12 months without an alternative medical cause in order not to be considered of childbearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
- Vasectomized partner or vasectomized study participant must have received medical assessment of the surgical success.
- Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.
- Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method (LAM) are not acceptable methods of contraception. Female condom and male condom should not be used together.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Bascom Palmer Eye Institute
Miami, Florida, 33136
Adam Rothman, MD
About this study
Official title: Adjunctive Aflibercept Ahmed Glaucoma Valve (AAA) Study
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.
- Conditions
- Glaucoma
- Being tested
- Aflibercept Injection, Ahmed Tube Surgery
- Keywords
- glaucoma, glaucoma drainage implant, glaucoma tube shunt, Ahmed glaucoma valve, intravitreal injection, aflibercept
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept InjectionDrug
Also called Eylea
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.
Ahmed Tube SurgeryProcedure or surgery
Participants will receive standard of care Ahmed tube surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Aflibercept Injection; Procedure: 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. Receives: Procedure: Ahmed Tube Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative day 1, week 1, month 1, month 2, and month 3
Secondary outcomes (4)
Surgical failure
Percentage of participants who meet any predefined surgical failure criterion, including: (1) intraocular pressure (IOP) >21 mmHg and <20% reduction from baseline on two consecutive visits after Month 3; (2) IOP <5 mmHg on two consecutive visits after Month 3; (3) requirement for additional glaucoma surgery; or (4) loss of light perception vision.
Measured: up to 6 months
Medication Burden
Medication burden assessed as the number of intraocular pressure (IOP) lowering medications used by participants daily.
Measured: Postoperative day 1, week 1, month 1, month 2, month 3, and month 6
Hypertensive phase
Percentage of participants who experience a hypertensive phase, defined as intraocular pressure (IOP) greater than 21 mmHg, with or without glaucoma medications, during the first 3 months after surgery following a reduction of IOP to less than 22 mmHg during the first postoperative week. Hypertensive phase is a known risk factor for surgical failure.
Measured: Up to 3 months
Treatment adverse events and serious treatment adverse events
Percentage of participants experiencing at least one treatment-related adverse event (AE) or serious adverse event (SAE).
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Principal investigator, Adam Rothman, University of Miami
- Investigators
- Adam Rothman, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891182
- Sponsor's protocol ID
- 20250108
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No