Age-Related Macular DegenerationNCT05542381
The Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain
A study testing Loteprednol Etabonate Ophthalmic Gel [Lotemax] and Refresh Lubricant Eye Drops [Artificial Tears] in people with Age-Related Macular Degeneration, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial summary
Patients are already receiving an intravitreal injection as a standard of care, but they are consenting to receiving a loteprednol drop following the intravitreal injection. This clinical trial is studying the role of loteprednol (corticosteroid) in reducing pain following intravitreal injections for patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- Loteprednol Etabonate Ophthalmic Gel [Lotemax] and Refresh Lubricant Eye Drops [Artificial Tears]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2022to 1 May 2025
- Phase
- Interventional
- 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
- All patients must have age-related macular degeneration and be undergoing intravitreal injections for treatment as defined by a retina specialist.
Who cannot join
- Dementia
- Report baseline eye pain
- Use topical NSAIDs or steroids
- Patient under 18 years old
- History of corticosteroid responsive elevation in intraocular pressure
- Allergy to Loteprednol or Nepafenac
Show all 14Show fewer
- Pre-existing chronic pain disorders
- Advanced Glaucoma
- Herpes zoster
- Allergy to local anesthetic or penicillin
- Patients unable to consent on own behalf
- Patients unable to communicate pain
- Pregnancy
- Incarceration
Trial locations and contacts
1 site in 1 country.
About this study
Patients are already receiving an intravitreal injection as a standard of care, but they are consenting to receiving a loteprednol drop following the intravitreal injection. This clinical trial is studying the role of loteprednol (corticosteroid) in reducing pain following intravitreal injections for patients with age-related macular degeneration. As of now, there is no definitive pain management technique following intravitreal injections. Loteprednol is a corticosteroid widely used in ophthalmology to treat pain and inflammation, however, it has not been studied as a treatment for pain following intravitreal injections. Our overall goal is to manage pain to improve quality of care after intravitreal injections. Participants will be given either loteprednol, or artificial tears following one visit for an intravitreal injection to test how effective loteprednol is in pain reduction. Pain levels will be assessed by asking participants over the phone about their pain from a scale of 0 to 10 at three different times over a 1-week period. Artificial tear and medication usage will also be tracked over a 1-week period.
Read the detailed description
Patients are already receiving an intravitreal injection as a standard of care for age-related macular degeneration, but they are consenting to receiving a loteprednol drop following the intravitreal injection for the research study. Loteprednol is used as a part of regular medical care at the Vistar Eye Center following intravitreal injections but quantifying the magnitude of pain reduction has not been done yet. Additionally, as of now there is no definitive pain management technique following intravitreal injections. This clinical trial is studying the role of loteprednol (corticosteroid) in reducing pain following intravitreal injections for patients with age-related macular degeneration. Participants will be treated with either loteprednol, or artificial tears following one visit for an intravitreal injection at the Vistar Eye Center to test how effective loteprednol is in pain reduction. Pain levels will be assessed by asking participants over the phone about their pain from a scale of 0 to 10 at 2-hours, 1-day, and 1-week following the intravitreal injection. Intravitreal injections will be performed by the retina surgeon, and phone calls will be done with the research coordinator. Artificial tear and medication usage will also be tracked over a 1-week period.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- Loteprednol Etabonate Ophthalmic Gel [Lotemax], Refresh Lubricant Eye Drops [Artificial Tears]
- Keywords
- Loteprednol, Loteprednol Etabonate Ophthalmic Suspension, Immunosuppressive Agents, Glucocorticoids, Immunologic Factors, Molecular Mechanisms of Pharmacological Action, Eye Diseases, Retinal Diseases, Anti-Inflammatory Agents, vascular endothelial growth factor, Intravitreal Injection, Post-Intravitreal Injection Pain
- Medical subject headings
- Macular Degeneration, Eye Diseases, Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loteprednol Etabonate Ophthalmic Gel [Lotemax]Drug
Loteprednol (ophthalmic corticosteroid) will be stored in the clinic according to the instructions on the package. The vial will be stored upright between 15°-25°C (59°-77°F). In the clinic, the vial will be opened by the retina surgeon according to sterile procedure and administered (1 drop) by the surgeon immediately after the intravitreal injection.
Refresh Lubricant Eye Drops [Artificial Tears]Other
Also called Refresh
REFRESH® Brand Lubricant Eye Drops are artificial tears. In the clinic, the vial will be opened by the retina surgeon according to sterile procedure and administered (1 drop) by the surgeon immediately after the intravitreal injection.
| Study group | Role | What they receive |
|---|---|---|
| Loteprednol | Experimental | 1 drop of Loteprednol is administered immediately after the intravitreal injection in this treatment arm. Receives: Drug: Loteprednol Etabonate Ophthalmic Gel [Lotemax] |
| Artificial tears | Placebo comparator | 1 drop of artificial tears is administered immediately after the intravitreal injection in this treatment arm. This arm acts as a negative control. Receives: Other: Refresh Lubricant Eye Drops [Artificial Tears] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Intravitreal Injection Pain
11-point Numerical Rating Scale (0-10, 0 being the lowest level of pain and 10 being highest level of pain)
Measured: 2-hour Post-Intravitreal Injection
Post-Intravitreal Injection Pain
11-point Numerical Rating Scale (0-10, 0 being the lowest level of pain and 10 being highest level of pain)
Measured: 1-day Post-Intravitreal Injection
Post-Intravitreal Injection Pain
11-point Numerical Rating Scale (0-10, 0 being the lowest level of pain and 10 being highest level of pain)
Measured: 1-week Post-Intravitreal Injection
Secondary outcomes (6)
Analgesic Medication Use
Pill count
Measured: 2-hour Post-Intravitreal Injection
Analgesic Medication Use
Pill count
Measured: 1-day Post-Intravitreal Injection
Analgesic Medication Use
Pill count
Measured: 1-week Post-Intravitreal Injection
Artificial Tear Use
Artificial Tear Drop Count
Measured: 2-hour Post-Intravitreal Injection
Artificial Tear Use
Artificial Tear Drop Count
Measured: 1-day Post-Intravitreal Injection
Artificial Tear Use
Artificial Tear Drop Count
Measured: 1-week Post-Intravitreal Injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start22 Dec 2022
- Primary completion1 May 2024
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Age-Related 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded placebo-controlled design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Collaborators
- Vistar Eye Center
- Responsible party
- Principal investigator, Vishak John, Virginia Polytechnic Institute and State University
- Investigators
- Vishak John, MD, Principal investigator, Vistar Eye CenterRomulo Albuquerque, M.D., Ph.D., Principal investigator, Vistar Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542381
- Sponsor's protocol ID
- 22-514
- Status last verified
- Jan 2025
- First submitted
- 1 Sep 2022
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ambati J, Fowler BJ. Mechanisms of age-related macular degeneration. Neuron. 2012 Jul 12;75(1):26-39. doi: 10.1016/j.neuron.2012.06.018.
PubMed 22794258Amon M, Busin M. Loteprednol etabonate ophthalmic suspension 0.5 %: efficacy and safety for postoperative anti-inflammatory use. Int Ophthalmol. 2012 Oct;32(5):507-17. doi: 10.1007/s10792-012-9589-2. Epub 2012 Jun 16.
PubMed 22707339Chou R, McDonagh MS, Nakamoto E, Griffin J. Analgesics for Osteoarthritis: An Update of the 2006 Comparative Effectiveness Review [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2011 Oct. Report No.: 11(12)-EHC076-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK65646/
PubMed 22091473DeCroos FC, Afshari NA. Perioperative antibiotics and anti-inflammatory agents in cataract surgery. Curr Opin Ophthalmol. 2008 Jan;19(1):22-6. doi: 10.1097/ICU.0b013e3282f30577.
PubMed 18090893El-Harazi SM, Feldman RM. Control of intra-ocular inflammation associated with cataract surgery. Curr Opin Ophthalmol. 2001 Feb;12(1):4-8. doi: 10.1097/00055735-200102000-00002.
PubMed 11150074Fong R, Cavet ME, DeCory HH, Vittitow JL. Loteprednol etabonate (submicron) ophthalmic gel 0.38% dosed three times daily following cataract surgery: integrated analysis of two Phase III clinical studies. Clin Ophthalmol. 2019 Aug 1;13:1427-1438. doi: 10.2147/OPTH.S210597. eCollection 2019.
PubMed 31447544Grzybowski A, Told R, Sacu S, Bandello F, Moisseiev E, Loewenstein A, Schmidt-Erfurth U; Euretina Board. 2018 Update on Intravitreal Injections: Euretina Expert Consensus Recommendations. Ophthalmologica. 2018;239(4):181-193. doi: 10.1159/000486145. Epub 2018 Feb 1.
PubMed 29393226Gundogan FC, Yolcu U, Akay F, Ilhan A, Ozge G, Uzun S. Diabetic Macular Edema. Pak J Med Sci. 2016 Mar-Apr;32(2):505-10. doi: 10.12669/pjms.322.8496.
PubMed 27182271Kaplan RI, Drinkwater OJ, Lee RH, Chod RB, Barash A, Giovinazzo JV, Gologorsky D, Jansen ME, Rosen RB, Gentile RC. Pain Control after Intravitreal Injection Using Topical Nepafenac 0.3% or Pressure Patching: A Randomized, Placebo-Controlled Trial. Ophthalmol Retina. 2019 Oct;3(10):860-866. doi: 10.1016/j.oret.2019.04.022. Epub 2019 Apr 26.
PubMed 31221565Kaplan RI, Rosen RB, Gentile RC. Optimizing the Patient Experience and Satisfaction: The Role of Topical NSAIDs with Intravitreal Injections. Ophthalmol Retina. 2020 May;4(5):459-460. doi: 10.1016/j.oret.2020.03.004. No abstract available.
PubMed 32381252Karia N. Retinal vein occlusion: pathophysiology and treatment options. Clin Ophthalmol. 2010 Jul 30;4:809-16. doi: 10.2147/opth.s7631.
PubMed 20689798Oztas Z, Akkin C, Afrashi F, Nalcaci S. The short-needle intravitreal injection technique. Int J Ophthalmol. 2016 Jun 18;9(6):929-30. doi: 10.18240/ijo.2016.06.24. eCollection 2016. No abstract available.
PubMed 27366700Popovic MM, Muni RH, Nichani P, Kertes PJ. Topical Nonsteroidal Anti-inflammatory Drugs for Pain Resulting from Intravitreal Injections: A Meta-Analysis. Ophthalmol Retina. 2020 May;4(5):461-470. doi: 10.1016/j.oret.2020.01.024. Epub 2020 Feb 13.
PubMed 32199867Rifkin L, Schaal S. Shortening ocular pain duration following intravitreal injections. Eur J Ophthalmol. 2012 Nov-Dec;22(6):1008-12. doi: 10.5301/ejo.5000147. Epub 2012 Apr 24.
PubMed 22562296Shin SH, Park SP, Kim YK. Factors Associated with Pain Following Intravitreal Injections. Korean J Ophthalmol. 2018 Jun;32(3):196-203. doi: 10.3341/kjo.2017.0081. Epub 2018 May 15.
PubMed 29770638
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain
- ClinicalTrials.gov ID
- NCT05542381
- Acronym / sponsor ID
- 22-514
- Conditions
- Age-Related Macular Degeneration
- Keywords
- Loteprednol, Loteprednol Etabonate Ophthalmic Suspension, Immunosuppressive Agents, Glucocorticoids, Immunologic Factors, Molecular Mechanisms of Pharmacological Action, Eye Diseases, Retinal Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- Vistar Eye Center
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 15 Sep 2022 (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.
Patients are already receiving an intravitreal injection as a standard of care, but they are consenting to receiving a loteprednol drop following the intravitreal injection. This clinical trial is studying the role of loteprednol (corticosteroid) in reducing pain following intravitreal injections for patients with age-related macular degeneration. As of now, there is no definitive pain management technique following intravitreal injections. Loteprednol is a corticosteroid widely used in ophthalmology to treat pain and inflammation, however, it has not been studied as a treatment for pain following intravitreal injections. Our overall goal is to manage pain to improve quality of care after intravitreal injections. Participants will be given either loteprednol, or artificial tears following one visit for an intravitreal injection to test how effective loteprednol is in pain reduction. Pain levels will be assessed by asking participants over the phone about their pain from a scale of 0 to 10 at three different times over a 1-week period. Artificial tear and medication usage will also be tracked over a 1-week period.
Detailed description
Patients are already receiving an intravitreal injection as a standard of care for age-related macular degeneration, but they are consenting to receiving a loteprednol drop following the intravitreal injection for the research study. Loteprednol is used as a part of regular medical care at the Vistar Eye Center following intravitreal injections but quantifying the magnitude of pain reduction has not been done yet. Additionally, as of now there is no definitive pain management technique following intravitreal injections. This clinical trial is studying the role of loteprednol (corticosteroid) in reducing pain following intravitreal injections for patients with age-related macular degeneration. Participants will be treated with either loteprednol, or artificial tears following one visit for an intravitreal injection at the Vistar Eye Center to test how effective loteprednol is in pain reduction. Pain levels will be assessed by asking participants over the phone about their pain from a scale of 0 to 10 at 2-hours, 1-day, and 1-week following the intravitreal injection. Intravitreal injections will be performed by the retina surgeon, and phone calls will be done with the research coordinator. Artificial tear and medication usage will also be tracked over a 1-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded placebo-controlled design
| Arm | Type | Receives |
|---|---|---|
| Loteprednol | Experimental | Drug: Loteprednol Etabonate Ophthalmic Gel [Lotemax]1 drop of Loteprednol is administered immediately after the intravitreal injection in this treatment arm. |
| Artificial tears | Placebo comparator | Other: Refresh Lubricant Eye Drops [Artificial Tears]1 drop of artificial tears is administered immediately after the intravitreal injection in this treatment arm. This arm acts as a negative control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients must have age-related macular degeneration and be undergoing intravitreal injections for treatment as defined by a retina specialist.
Key exclusion criteria (14 listed)
- Dementia
- Report baseline eye pain
- Use topical NSAIDs or steroids
- Patient under 18 years old
- History of corticosteroid responsive elevation in intraocular pressure
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 |
|---|---|---|
| Loteprednol Etabonate Ophthalmic Gel [Lotemax]Loteprednol (ophthalmic corticosteroid) will be stored in the clinic according to the instructions on the package. The vial will be stored upright between 15°-25°C (59°-77°F). In the clinic, the vial will be opened by the retina surgeon according to sterile procedure and administered (1 drop) by the surgeon immediately after the intravitreal injection. | Drug | Loteprednol |
| Refresh Lubricant Eye Drops [Artificial Tears]Also: RefreshREFRESH® Brand Lubricant Eye Drops are artificial tears. In the clinic, the vial will be opened by the retina surgeon according to sterile procedure and administered (1 drop) by the surgeon immediately after the intravitreal injection. | Other | Artificial tears |
Primary outcome
Post-Intravitreal Injection Pain
Time frame: 2-hour Post-Intravitreal Injection
11-point Numerical Rating Scale (0-10, 0 being the lowest level of pain and 10 being highest level of pain)
Post-Intravitreal Injection Pain
Time frame: 1-day Post-Intravitreal Injection
11-point Numerical Rating Scale (0-10, 0 being the lowest level of pain and 10 being highest level of pain)
Post-Intravitreal Injection Pain
Time frame: 1-week Post-Intravitreal Injection
11-point Numerical Rating Scale (0-10, 0 being the lowest level of pain and 10 being highest level of pain)
6 secondary outcomes
Analgesic Medication Use
Time frame: 2-hour Post-Intravitreal Injection
Analgesic Medication Use
Time frame: 1-day Post-Intravitreal Injection
Analgesic Medication Use
Time frame: 1-week Post-Intravitreal Injection
Artificial Tear Use
Time frame: 2-hour Post-Intravitreal Injection
Artificial Tear Use
Time frame: 1-day Post-Intravitreal Injection
Artificial Tear Use
Time frame: 1-week Post-Intravitreal Injection
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 19 Sep 2025.
- Background: PubMed 22794258Ambati J, Fowler BJ. Mechanisms of age-related macular degeneration. Neuron. 2012 Jul 12;75(1):26-39. doi: 10.1016/j.neuron.2012.06.018.
- Background: PubMed 22707339Amon M, Busin M. Loteprednol etabonate ophthalmic suspension 0.5 %: efficacy and safety for postoperative anti-inflammatory use. Int Ophthalmol. 2012 Oct;32(5):507-17. doi: 10.1007/s10792-012-9589-2. Epub 2012 Jun 16.
- Background: PubMed 22091473Chou R, McDonagh MS, Nakamoto E, Griffin J. Analgesics for Osteoarthritis: An Update of the 2006 Comparative Effectiveness Review [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2011 Oct. Report No.: 11(12)-EHC076-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK65646/
- Background: PubMed 18090893DeCroos FC, Afshari NA. Perioperative antibiotics and anti-inflammatory agents in cataract surgery. Curr Opin Ophthalmol. 2008 Jan;19(1):22-6. doi: 10.1097/ICU.0b013e3282f30577.
- Background: PubMed 11150074El-Harazi SM, Feldman RM. Control of intra-ocular inflammation associated with cataract surgery. Curr Opin Ophthalmol. 2001 Feb;12(1):4-8. doi: 10.1097/00055735-200102000-00002.
- Background: PubMed 31447544Fong R, Cavet ME, DeCory HH, Vittitow JL. Loteprednol etabonate (submicron) ophthalmic gel 0.38% dosed three times daily following cataract surgery: integrated analysis of two Phase III clinical studies. Clin Ophthalmol. 2019 Aug 1;13:1427-1438. doi: 10.2147/OPTH.S210597. eCollection 2019.
- Background: PubMed 29393226Grzybowski A, Told R, Sacu S, Bandello F, Moisseiev E, Loewenstein A, Schmidt-Erfurth U; Euretina Board. 2018 Update on Intravitreal Injections: Euretina Expert Consensus Recommendations. Ophthalmologica. 2018;239(4):181-193. doi: 10.1159/000486145. Epub 2018 Feb 1.
- Background: PubMed 27182271Gundogan FC, Yolcu U, Akay F, Ilhan A, Ozge G, Uzun S. Diabetic Macular Edema. Pak J Med Sci. 2016 Mar-Apr;32(2):505-10. doi: 10.12669/pjms.322.8496.
- Background: PubMed 31221565Kaplan RI, Drinkwater OJ, Lee RH, Chod RB, Barash A, Giovinazzo JV, Gologorsky D, Jansen ME, Rosen RB, Gentile RC. Pain Control after Intravitreal Injection Using Topical Nepafenac 0.3% or Pressure Patching: A Randomized, Placebo-Controlled Trial. Ophthalmol Retina. 2019 Oct;3(10):860-866. doi: 10.1016/j.oret.2019.04.022. Epub 2019 Apr 26.
- Background: PubMed 32381252Kaplan RI, Rosen RB, Gentile RC. Optimizing the Patient Experience and Satisfaction: The Role of Topical NSAIDs with Intravitreal Injections. Ophthalmol Retina. 2020 May;4(5):459-460. doi: 10.1016/j.oret.2020.03.004. No abstract available.
- Background: PubMed 20689798Karia N. Retinal vein occlusion: pathophysiology and treatment options. Clin Ophthalmol. 2010 Jul 30;4:809-16. doi: 10.2147/opth.s7631.
- Background: PubMed 27366700Oztas Z, Akkin C, Afrashi F, Nalcaci S. The short-needle intravitreal injection technique. Int J Ophthalmol. 2016 Jun 18;9(6):929-30. doi: 10.18240/ijo.2016.06.24. eCollection 2016. No abstract available.
- Lotemax InformationLink provided by the sponsor.
- 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.
Vishak John, MD principal investigator
Vistar Eye Center
Romulo Albuquerque, M.D., Ph.D. principal investigator
Vistar Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Loteprednol Etabonate Ophthalmic Gel [Lotemax] and Refresh Lubricant Eye Drops [Artificial Tears] in people with Age-Related Macular Degeneration, run by Virginia Polytechnic Institute and State University 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 14 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 19 Sep 2025. 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.
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?
Post-Intravitreal Injection Pain (time frame: 2-hour Post-Intravitreal Injection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05542381, which also lists 19 linked publications.
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 19 Sep 2025.