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CompletedNCT07779356Updated Aug 21, 2026

Patient Comfort Following Intravitreal Injections Using Iheezo Versus Standard Anesthesia

A Phase 4 interventional study of Iheezo and Lidocaine pledget in Macular Degeneration, Diabetic Retinopathy and Retinal Vein Occlusion (RVO), sponsored by Retina Consultants of Delmarva. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Retina Consultants of Delmarva · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Prospective comparative clinical study.

One hundred eyes of 50 patients were included. All patients received bilateral same-day intravitreal injections, with Iheezo administered to only one randomly selected eye and standard topical anesthesia administered to the contralateral control eye. Ocular discomfort was assessed using a 0-10 numeric rating scale at 2 minutes, 1 hour, 6-12 hours, and 24 hours following injection. The primary longitudinal analysis used a linear mixed-effects model incorporating treatment group, assessment time, and treatment-by-time interaction as fixed effects and patient as a random effect. Between-group differences at individual time points were evaluated using Welch two-sample comparisons with Holm adjustment for multiple comparisons. Patient-level mean discomfort across the four assessments was also compared between groups.

02

Conditions studied

  • Macular Degeneration
  • Diabetic Retinopathy
  • Retinal Vein Occlusion (RVO)
03

In context

Macular Degeneration

1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.

This study's enrollment of 50 is below the median of 56 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Retina Consultants of Delmarva is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Anyone receiving bilateral same day intravitreal injections as standard care

Exclusion criteria

Exclusion Criteria:

  • Inability to complete post-injection survey
  • History of receiving Iheezo
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Iheezo

    Standard anesthesia plus iheezo prior to injection

    Drug: Iheezo

  • Placebo comparator
    No iheezo

    Standard anesthesia alone

    Drug: Lidocaine pledget

Interventions

  • DrugIheezo

    Iheezo applied prior to injection

  • DrugLidocaine pledget

    Standard anesthesia in practice, as proparacaine drops plus lidocaine pledget

06

What researchers measure

Primary outcomes

  1. Discomfort after injection

    Rated 0-10 in each eye

    Time frame: 2 minutes to 24 hours after injection

07

Study locations

1 site
  • Retina Consultants of Delmarva
    Easton, Maryland 21601, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2026 to primary completion in Aug 2026, 2 months.

Of 45 phase 4 interventional studies under Macular Degeneration, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 39. This study's 2 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 19, 2026
First posted
Aug 21, 2026
StartActual
May 20, 2026
Primary completionActual
Aug 7, 2026
CompletionActual
Aug 11, 2026
Last update
Aug 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07779356
Lead sponsor
Retina Consultants of Delmarva
Collaborators
Harrow Inc
Responsible party
Travis Peck (Principal Investigator, physician, Retina Consultants of Delmarva) — Principal investigator
First posted
Aug 21, 2026
Start date
May 20, 2026
Primary completion
Aug 7, 2026
Completion
Aug 11, 2026
Last update
Aug 21, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Chloroprocaine

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