Patient Comfort Following Intravitreal Injections Using Iheezo Versus Standard Anesthesia

NCT07779356 | Completed Phase 4 FDA Drug

• 1 other identifier: 20261835
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Macular Degeneration; Diabetic Retinopathy; Retinal Vein Occlusion (RVO)

Outcome Measures

Primary Outcomes (1)

• Discomfort after injection

  Rated 0-10 in each eye

  2 minutes to 24 hours after injection

Study Arms (2)

Iheezo

EXPERIMENTAL

Standard anesthesia plus iheezo prior to injection

Drug: Iheezo

No iheezo

PLACEBO COMPARATOR

Standard anesthesia alone

Drug: Lidocaine pledget

Interventions

Iheezo DRUG

Iheezo applied prior to injection

Iheezo

Lidocaine pledget DRUG

Standard anesthesia in practice, as proparacaine drops plus lidocaine pledget

No iheezo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Anyone receiving bilateral same day intravitreal injections as standard care

You may not qualify if:

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

Sponsors & Collaborators

• Retina Consultants of Delmarva: lead
• Harrow Inc: collaborator

Study Sites (1)

Retina Consultants of Delmarva

Easton, Maryland, 21601, United States

Location

MeSH Terms

Conditions

Macular Degeneration; Diabetic Retinopathy; Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, physician

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 21, 2026
• Study Start: May 20, 2026
• Primary Completion: August 7, 2026
• Study Completion: August 11, 2026
• Last Updated: August 21, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)