RECRUITINGPhase 4INTERVENTIONAL

Study Evaluating the Efficacy and Safety of Chloroprocaine HCl Ophthalmic Gel 3% vs Proparacaine Ophthalmic Solution 0.5% Plus Subconjunctival Lidocaine in Patients Undergoing Intravitreal Injections

A Phase 4, Multisite, Randomized, Double-Masked, Well-Controlled Study Evaluating the Efficacy and Safety of Chloroprocaine HCl Ophthalmic Gel 3% vs Proparacaine Ophthalmic Solution 0.5% Plus Subconjunctival Lidocaine in Patients Undergoing Intravitreal Injections: The QUELL Study

About This Trial

This Phase 4, multicenter, randomized, double-masked clinical study evaluates the efficacy and safety of chloroprocaine hydrochloride ophthalmic gel 3% (IHEEZO) compared with routine anesthesia (topical proparacaine 0.5% combined with subconjunctival lidocaine 2%) for ocular surface anesthesia during intravitreal injection procedures. Adult participants scheduled to undergo unilateral intravitreal injection of an FDA-approved anti-vascular endothelial growth factor (anti-VEGF) agent for retinal conditions will be randomized in a 1:1 ratio to receive either IHEEZO with a sham subconjunctival procedure or routine anesthesia. The primary objective is to determine whether IHEEZO is non-inferior to routine anesthesia in achieving successful ocular surface anesthesia, defined as a participant-reported pain score of 0 or 1 (on a 0-5 ordinal pain scale) immediately before and immediately after intravitreal injection. Secondary outcomes include individual and cumulative pain scores, change from baseline in dry eye symptoms measured by the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire, and ocular safety assessments through Day 7 follow-up.

Who May Be Eligible (Plain English)

Who May Qualify: - Able to understand and voluntarily provide written willing to sign a consent form prior to initiation of any study-specific procedures - Male or female, age ≥ 18 years - Scheduled to undergo unilateral, uncomplicated intravitreal injection of an FDA-approved, non-biosimilar anti-VEGF agent in the study eye - Diagnosis requiring anti-vascular endothelial growth factor (anti-VEGF) treatment, including macular edema (cystoid or diabetic), retinal vein occlusion, diabetic retinopathy, or neovascular age-related macular degeneration - At least three prior intravitreal anti-VEGF injections in the study eye - Fewer than 13 intravitreal anti-VEGF injections in the study eye within the last 365 days - Willing and able to comply with study procedures and follow-up assessments Who Should NOT Join This Trial: - Scheduled to undergo simultaneous bilateral intravitreal injection - Pre-existing eye pain in the study eye - Fewer than three prior intravitreal anti-VEGF injections in the study eye within 365 days prior to enrollment - Mental disability or cognitive impairment that prevents reliable pain assessment - Prisoner - Pregnant or breastfeeding - Woman of childbearing potential not using an acceptable method of contraception - Inability to comply with study procedures or follow-up assessments - Known sensitivity or allergy to any study medications or related drug classes - History of resistance to local anesthetics - History of Ehlers-Danlos syndrome - Participation in another investigational drug or device study within 30 days prior to screening (unless previously randomized to a control group receiving Eylea, Eylea HD, Lucentis, or Vabysmo) - Use of pain medication, opioids, analgesics, or NSAIDs (any route) within 24 hours prior to Visit 1 - Clinically significant systemic disease or condition that, in the Investigator's judgment, may compromise safety or study integrity ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Able to understand and voluntarily provide written informed consent prior to initiation of any study-specific procedures * Male or female, age ≥ 18 years * Scheduled to undergo unilateral, uncomplicated intravitreal injection of an FDA-approved, non-biosimilar anti-VEGF agent in the study eye * Diagnosis requiring anti-vascular endothelial growth factor (anti-VEGF) treatment, including macular edema (cystoid or diabetic), retinal vein occlusion, diabetic retinopathy, or neovascular age-related macular degeneration * At least three prior intravitreal anti-VEGF injections in the study eye * Fewer than 13 intravitreal anti-VEGF injections in the study eye within the last 365 days * Willing and able to comply with study procedures and follow-up assessments Exclusion Criteria: * Scheduled to undergo simultaneous bilateral intravitreal injection * Pre-existing eye pain in the study eye * Fewer than three prior intravitreal anti-VEGF injections in the study eye within 365 days prior to enrollment * Mental disability or cognitive impairment that prevents reliable pain assessment * Prisoner * Pregnant or breastfeeding * Woman of childbearing potential not using an acceptable method of contraception * Inability to comply with study procedures or follow-up assessments * Known sensitivity or allergy to any study medications or related drug classes * History of resistance to local anesthetics * History of Ehlers-Danlos syndrome * Participation in another investigational drug or device study within 30 days prior to screening (unless previously randomized to a control group receiving Eylea, Eylea HD, Lucentis, or Vabysmo) * Use of pain medication, opioids, analgesics, or NSAIDs (any route) within 24 hours prior to Visit 1 * Clinically significant systemic disease or condition that, in the Investigator's judgment, may compromise safety or study integrity * Cataract extraction, intraocular surgery, or extraocular surgery within 60 days prior to enrollment that may affect ocular pain * History of autoimmune disease, graft-versus-host disease, fibromyalgia, uveitis, neurotrophic corneal disease, keratitis or corneal ulceration, uncontrolled glaucoma, or herpetic ocular disease * History of endophthalmitis or ocular trauma within 3 months prior to enrollment * Pre-existing subconjunctival hemorrhage or bulbar conjunctival hyperemia * Chronic ocular pain rated moderate to severe within 1 week prior to Visit 1 * Active bacterial or viral infection in either eye

Treatments Being Tested

DRUG

Chloroprocaine Ophthalmic Gel 3% (IHEEZO)

Preservative-free chloroprocaine hydrochloride ophthalmic gel 3% administered as 3 topical drops to the study eye prior to intravitreal injection.

PROCEDURE

Sham Subconjunctival Injection

Sham procedure performed using a syringe with a blunt-tipped cannula that does not contact the conjunctiva, performed to maintain masking prior to intravitreal injection.

DRUG

Proparacaine Hydrochloride Ophthalmic Solution 0.5%

Topical proparacaine hydrochloride ophthalmic solution 0.5% administered as 3 drops to the study eye prior to intravitreal injection.

DRUG

Lidocaine Hydrochloride Injection 2%

Subconjunctival injection of lidocaine hydrochloride 2% administered after topical proparacaine and prior to intravitreal injection.

Locations (1)

Tyler Retina Research Institute

Tyler, Texas, United States