Patient Preferences on Same-day Bilateral Intravitreal Dexamethasone Injections

NCT06894017 | Recruiting FDA Drug

• 1 other identifier: p-2024-16883
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Intravitreal injections with dexamethasone implant (Ozurdex®) provide a reasonable and long-lasting treatment option in the cases of diabetic macular edema, as well as macular edema resulting from retinal vein occlusion and noninfectious posterior uveitis. During the course of these diseases, both eyes may be affected and may need therapy. The treatment burden associated with frequent medical visits associated with treatments in both eyes and follow-ups can be significant for patients and caregivers alike. Same-session bilateral ophthalmic procedures have proven safe and cost-effective, with patients consistently expressing a strong preference for this approach, particularly in the cases of cataract surgery and anti-VEGF injections when given the choice. The safety profile of same-day bilateral dexamethasone injections aligns with those of unilateral injections. This patient preference study will focus on addressing the practical aspects of same-day bilateral dexamethasone injections from the patients' perspective and aims to explore the impact of personal and socio-economic variables, and the overall perspective of patients on choosing same-day bilateral dexamethasone injections. Understanding and mitigating the challenges patients face can lead to a more patient-friendly and resource-saving approach. Based on the outcomes of this study, considerations may be made to introduce bilateral injections at our department, potentially optimizing patient experience and clinical resources. The aim of the study is to establish patient preferences regarding the administration of intravitreal dexamethasone implant injections in both eyes on the same day, in the same session and to identify key motivating and limiting factors from the patients' perspective.

Conditions

Informed Consent; Preference, Patient

Keywords

Intravitreal; dexamethasone; injections; implant; questionnaire; patient preference; bilateral

Outcome Measures

Primary Outcomes (1)

• Preference to bilateral injections

  Proportion of patients preferring and not preferring same-day bilateral dexamethasone implant injections

  Through study completion, an average of 9 months

Secondary Outcomes (3)

• Reasons

  Through study completion, an average of 9 months

• Differences in patient characteristics

  Through study completion, an average of 9 months

• Differences in socio-economic variables between preference groups

  Through study completion, an average of 9 months

Interventions

Ozurdex (dexamethasone) DRUG

Intravitreal dexamethasone implant (Ozurdex) given according to the recommendations by the manufacturer.

Also known as: Intravitreal dexamethasone implant

Eligibility Criteria

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

Study Population

Patients of the Capital Region of Denmark who are treated at Rigshospitalet.

You may qualify if:

• Having received at least one intravitreal dexamethasone implant in either eye
• \>18 years of age
• Capacity to comprehend and answer questions in Danish language
• Signed informed consent

You may not qualify if:

• No intravitreal dexamethasone implant received within the last 12 months

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Ophthalmology, Rigshospitalet

Glostrup Municipality, 2600, Denmark

RECRUITING

Related Publications (9)

• Bridges JFP, de Bekker-Grob EW, Hauber B, Heidenreich S, Janssen E, Bast A, Hanmer J, Danyliv A, Low E, Bouvy JC, Marshall DA. A Roadmap for Increasing the Usefulness and Impact of Patient-Preference Studies in Decision Making in Health: A Good Practices Report of an ISPOR Task Force. Value Health. 2023 Feb;26(2):153-162. doi: 10.1016/j.jval.2022.12.004.

  PMID: 36754539 BACKGROUND

• Lin TC, Tseng PC, Hsu TK, Huang HW, Huang YM, Lo WJ, Chao CY, Chung YC. Same-Day Bilateral Intravitreal Dexamethasone Implants for the Treatment of Diabetic Macular Edema. Ophthalmologica. 2023;246(3-4):238-244. doi: 10.1159/000532056. Epub 2023 Aug 8.

  PMID: 37552956 BACKGROUND

• Kapoor KG, Colchao JB. SAFETY OF CONSECUTIVE SAME-DAY BILATERAL INTRAVITREAL DEXAMETHASONE IMPLANT (OZURDEX). Retin Cases Brief Rep. 2020 Spring;14(2):200-202. doi: 10.1097/ICB.0000000000000653.

  PMID: 29155696 BACKGROUND

• Dinh RH, Moushmoush O, Kolyvas P, Jacobsen BA, Mathai M, Sanghavi K, Levinson JD, Do BK. Describing Adverse Events Associated with Bilateral Same-Day Intravitreal Dexamethasone Implants. Ophthalmic Surg Lasers Imaging Retina. 2022 Nov;53(11):612-618. doi: 10.3928/23258160-20221018-04. Epub 2022 Nov 1.

  PMID: 36378615 BACKGROUND

• Malcolm J, Leak C, Day AC, Baker H, Buchan JC. Immediate sequential bilateral cataract surgery: patient perceptions and preferences. Eye (Lond). 2023 May;37(7):1509-1514. doi: 10.1038/s41433-022-02171-7. Epub 2022 Jul 20.

  PMID: 35859120 BACKGROUND

• Mahajan VB, Elkins KA, Russell SR, Boldt HC, Gehrs KM, Weingeist TA, Stone EM, Abramoff MD, Liu D, Folk JC. Bilateral intravitreal injection of antivascular endothelial growth factor therapy. Retina. 2011 Jan;31(1):31-5. doi: 10.1097/IAE.0b013e3181ed8c80.

  PMID: 21187731 BACKGROUND

• Dickman MM, Spekreijse LS, Winkens B, Schouten JS, Simons RW, Dirksen CD, Nuijts RM. Immediate sequential bilateral surgery versus delayed sequential bilateral surgery for cataracts. Cochrane Database Syst Rev. 2022 Apr 25;4(4):CD013270. doi: 10.1002/14651858.CD013270.pub2.

  PMID: 35467755 BACKGROUND

• Sav A, King MA, Whitty JA, Kendall E, McMillan SS, Kelly F, Hunter B, Wheeler AJ. Burden of treatment for chronic illness: a concept analysis and review of the literature. Health Expect. 2015 Jun;18(3):312-24. doi: 10.1111/hex.12046. Epub 2013 Jan 31.

  PMID: 23363080 BACKGROUND

• European Medicines Agency. Ozurdex. Accessed 21/11/2023, https://www.ema.europa.eu/en/medicines/human/EPAR/ozurdex

  BACKGROUND

MeSH Terms

Conditions

Patient Preference

Interventions

Calcium Dobesilate; Dexamethasone

Condition Hierarchy (Ancestors)

Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Miklos Schneider, MD, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lena Michelle Mørup Andersen, MScN

CONTACT

+4538634700; lena.michelle.moerup.andersen@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 25, 2025
• Study Start: January 13, 2025
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)