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

Prior treatment

• Fewer than three prior intravitreal anti-VEGF injections in the study eye within 365 days prior to enrollment
• 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
• Cataract extraction, intraocular surgery, or extraocular surgery within 60 days prior to enrollment that may affect ocular pain
• History of endophthalmitis or ocular trauma within 3 months prior to enrollment
• Chronic ocular pain rated moderate to severe within 1 week prior to Visit 1

Other illness

• Mental disability or cognitive impairment that prevents reliable pain assessment
• Known sensitivity or allergy to any study medications or related drug classes
• History of resistance to local anesthetics
• History of Ehlers-Danlos syndrome
• Clinically significant systemic disease or condition that, in the Investigator's judgment, may compromise safety or study integrity
• History of autoimmune disease, graft-versus-host disease, fibromyalgia, uveitis, neurotrophic corneal disease, keratitis or corneal ulceration, uncontrolled glaucoma, or herpetic ocular disease
• Pre-existing subconjunctival hemorrhage or bulbar conjunctival hyperemia
• Active bacterial or viral infection in either eye

Other

• Scheduled to undergo simultaneous bilateral intravitreal injection
• Pre-existing eye pain in the study eye
• 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

• 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