New gel could make eye injections Pain-Free
NCT ID NCT07456826
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares a new numbing gel (chloroprocaine HCl 3%) to standard eye drops plus a shot for pain relief during eye injections. About 236 adults with conditions like diabetic macular edema or age-related macular degeneration will take part. The goal is to see if the gel works as well as the usual method to keep patients comfortable.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 236 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tyler Retina Research Institute
Tyler, Texas, 75703, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can fewer eye injections dry the retina in wet AMD?
- The 20-Minute squeeze: how eye injections push pressure up
- High-Dose eye injection tested against stubborn diabetic swelling
- Could years of eye injections weigh down the upper eyelid?
- One eye injection, four targets: GenSci148 tested against retinal swelling
- Can one shot in the eye treat diabetic macular edema?