Macular DegenerationPhase 4NCT07779356
Patient Comfort Following Intravitreal Injections Using Iheezo Versus Standard Anesthesia
A Phase 4 study testing Iheezo and Lidocaine pledget in people with Macular Degeneration and Diabetic Retinopathy, run by Retina Consultants of Delmarva at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Degeneration, Diabetic Retinopathy, Retinal Vein Occlusion (RVO)
- What is being tested?
- Iheezo and Lidocaine pledget
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2026to 11 Aug 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Anyone receiving bilateral same day intravitreal injections as standard care
Who cannot join
- Inability to complete post-injection survey
- History of receiving Iheezo
Trial locations and contacts
1 site in 1 country.
United States1 site
Retina Consultants of Delmarva
Easton, Maryland, 21601
About this study
Official title: Comparative Evaluation of Patient Comfort Following Intravitreal Injections Using Iheezo Versus Standard Anesthesia in a Private Retina Practice
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.
- Being tested
- Iheezo, Lidocaine pledget
- Medical subject headings
- Macular Degeneration, Diabetic Retinopathy, Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IheezoDrug
Iheezo applied prior to injection
Lidocaine pledgetDrug
Standard anesthesia in practice, as proparacaine drops plus lidocaine pledget
| Study group | Role | What they receive |
|---|---|---|
| Iheezo | Experimental | Standard anesthesia plus iheezo prior to injection Receives: Drug: Iheezo |
| No iheezo | Placebo comparator | Standard anesthesia alone Receives: Drug: Lidocaine pledget |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discomfort after injection
Rated 0-10 in each eye
Measured: 2 minutes to 24 hours after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start20 May 2026
- Primary completion7 Aug 2026
- Study completion11 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Retina Consultants of Delmarva
- Sponsor type
- University, hospital or other
- Collaborators
- Harrow Inc
- Responsible party
- Principal investigator, Travis Peck, Retina Consultants of Delmarva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779356
- Sponsor's protocol ID
- 20261835
- Status last verified
- May 2026
- First submitted
- 19 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Patient Comfort Following Intravitreal Injections Using Iheezo Versus Standard Anesthesia in a Private Retina Practice
- ClinicalTrials.gov ID
- NCT07779356
- Acronym / sponsor ID
- 20261835
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Retina Consultants of DelmarvaUniversity, hospital or other
- Collaborators
- Harrow Inc
- Study start
- 20 May 2026 (actual)
- Primary completion
- 7 Aug 2026 (actual)
- Study completion
- 11 Aug 2026 (actual)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iheezo | Experimental | Drug: IheezoStandard anesthesia plus iheezo prior to injection |
| No iheezo | Placebo comparator | Drug: Lidocaine pledgetStandard anesthesia alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Anyone receiving bilateral same day intravitreal injections as standard care
Key exclusion criteria (2 listed)
- Inability to complete post-injection survey
- History of receiving Iheezo
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IheezoIheezo applied prior to injection | Drug | Iheezo |
| Lidocaine pledgetStandard anesthesia in practice, as proparacaine drops plus lidocaine pledget | Drug | No iheezo |
Primary outcome
Discomfort after injection
Time frame: 2 minutes to 24 hours after injection
Rated 0-10 in each eye
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iheezo and Lidocaine pledget in people with Macular Degeneration and Diabetic Retinopathy, run by Retina Consultants of Delmarva at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discomfort after injection (time frame: 2 minutes to 24 hours after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.