The Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain

Age-Related Macular Degeneration Clinical Trial

Official title:

The Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05542381
• Other study ID #: 22-514
• Status: Recruiting
• Phase: N/A
• Start date: December 22, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2024
• Source: Virginia Polytechnic Institute and State University
• Contact: Paul K Varghese
• Phone: 7033999886
• Email: paulv[@]vt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients must have age-related macular degeneration and be undergoing intravitreal injections for treatment as defined by a retina specialist.

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• 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.

Other:
• Refresh Lubricant Eye Drops [Artificial Tears]
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.

Locations

Country	Name	City	State
United States	Vistar Eye Center	Roanoke	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University	Vistar Eye Center

Country where clinical trial is conducted

United States, 

References & Publications (19)

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. — View Citation

Amon 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. — View Citation

Chou 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/ — View Citation

DeCroos 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. — View Citation

El-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. — View Citation

Fong 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. — View Citation

Grzybowski 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. — View Citation

Gundogan 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. — View Citation

Kaplan 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. — View Citation

Kaplan 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. — View Citation

Karia N. Retinal vein occlusion: pathophysiology and treatment options. Clin Ophthalmol. 2010 Jul 30;4:809-16. doi: 10.2147/opth.s7631. — View Citation

Oztas 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. — View Citation

Popovic 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. — View Citation

Rifkin 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. — View Citation

Shin 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. — View Citation

Tan HY, Agarwal A, Lee CS, Chhablani J, Gupta V, Khatri M, Nirmal J, Pavesio C, Agrawal R. Management of noninfectious posterior uveitis with intravitreal drug therapy. Clin Ophthalmol. 2016 Oct 13;10:1983-2020. doi: 10.2147/OPTH.S89341. eCollection 2016. — View Citation

Toslak D, Thapa D, Chen Y, Erol MK, Paul Chan RV, Yao X. Wide-field fundus imaging with trans-palpebral illumination. Proc SPIE Int Soc Opt Eng. 2017 Jan 28;10045:100451X. doi: 10.1117/12.2252491. Epub 2017 Feb 8. — View Citation

Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x. — View Citation

Yahalomi T, Hecht I, Lagstein O, Nemet A, Pe'er L, Hadad F, Keren-Yaar A, Kassem R, Burgansky-Eliash Z, Bar A, Achiron A. REDUCTION OF POSTINTRAVITREAL INJECTION PAIN USING ICE: An Open-Label Interventional Randomized Controlled Trial. Retina. 2020 Jul;40(7):1434-1438. doi: 10.1097/IAE.0000000000002608. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	2-hour Post-Intravitreal Injection
Primary	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)	1-day Post-Intravitreal Injection
Primary	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)	1-week Post-Intravitreal Injection
Secondary	Analgesic Medication Use	Pill count	2-hour Post-Intravitreal Injection
Secondary	Analgesic Medication Use	Pill count	1-day Post-Intravitreal Injection
Secondary	Analgesic Medication Use	Pill count	1-week Post-Intravitreal Injection
Secondary	Artificial Tear Use	Artificial Tear Drop Count	2-hour Post-Intravitreal Injection
Secondary	Artificial Tear Use	Artificial Tear Drop Count	1-day Post-Intravitreal Injection
Secondary	Artificial Tear Use	Artificial Tear Drop Count	1-week Post-Intravitreal Injection

External Links

•   Lotemax Information