Not yet recruitingPhase 2

VGFTe-(HD)-OD-2566: Adjunctive Aflibercept Ahmed Glaucoma Valve (AAA) Study

Adjunctive Aflibercept Ahmed Glaucoma Valve (AAA) Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether aflibercept shots in the eye help control eye pressure better than Ahmed tube surgery alone. Shots are given at the end of surgery and at one and two months after surgery. It is for adults with open-angle glaucoma whose eye pressure is not well controlled with medicines they can tolerate.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 85 years old.
  • You have open-angle glaucoma, a disease that damages the eye’s main nerve. Your eye pressure is 18 to 40 mm Hg despite using medicines you can tolerate.

Who can't join

  • You cannot agree to join, accept a treatment group chosen by chance, or return for study visits.
  • You cannot see light, or vision in your other eye is 20/200 or worse with glasses or contacts. You have no natural lens, or will not stop wearing contacts after surgery.
  • You have had a glaucoma drainage tube, a procedure to destroy tissue that makes eye fluid, a retinal support band, or anti-VEGF drugs in either eye. Anti-VEGF drugs block abnormal blood vessel growth. You need other eye surgery along with or after glaucoma surgery.
  • You have certain eye problems: diabetes-related eye damage, wet age-related macular degeneration, a blocked retinal vein, abnormal eye blood vessels, or past swelling in the center of the retina. The retina is the light-sensing layer at the back of the eye.
  • You have other listed eye problems, such as misplaced eye gel, abnormal tissue growth, severe eyelid inflammation, or scarring that blocks tube placement. You have ongoing or repeated inflammation inside the eye, had it within 90 days of surgery, or used steroid eye drops within 30 days of surgery.
  • Your blood pressure is above 165/95 or may be unstable. You had a stroke or heart attack within 180 days of surgery, receive blood-filtering dialysis, or have had a kidney transplant.
  • You are allergic to a study drug ingredient or have another condition that could make treatment unsafe or affect study results. You joined a drug or device treatment study within 30 days before screening, except one involving only vitamins or minerals.
  • You are pregnant or breastfeeding. If you or your partner could become pregnant, you are unwilling to use study-approved birth control before treatment, during the study, and for at least 3 months after the last dose.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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: 1. 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 2. intrauterine device (IUD); intrauterine hormone-releasing system (IUS) 3. bilateral tubal ligation 4. vasectomy 5. condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly 6. 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.

Study sites (1)

FL

  • Bascom Palmer Eye Institute · Miami, FL 33136Adam Rothman, MD · Principal investigatorMore trials in Miami