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Informed ConsentNCT06894017

Patient Preferences on Same-day Bilateral Intravitreal Dexamethasone Injections

An observational study of Informed Consent and Preference, Patient, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Informed Consent, Preference, Patient
What is being tested?
Ozurdex (dexamethasone)
How many people
200 participants
Where
1 siteDenmark
Study dates
13 Jan 2025to Jan 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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

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

Who may be able to join

  • 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

Who cannot join

  • No intravitreal dexamethasone implant received within the last 12 months

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lena Michelle Mørup Andersen, MScN contact

+4538634700

lena.michelle.moerup.andersen@regionh.dk

Denmark1 site, 1 recruiting

  • Department of Ophthalmology, Rigshospitalet

    Glostrup Municipality, 2600

    Lena Michelle Mørup Andersen, MScN, +4538634700, lena.michelle.moerup.andersen@regionh.dk

    Recruiting

Other trials in Denmark

About this study

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.

Being tested
Ozurdex (dexamethasone)
Keywords
Intravitreal, dexamethasone, injections, implant, questionnaire, patient preference, bilateral
Medical subject headings
Patient Preference

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ozurdex (dexamethasone)Drug

    Also called Intravitreal dexamethasone implant

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Preference to bilateral injections

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

    Measured: Through study completion, an average of 9 months

Secondary outcomes (3)

  1. Reasons

    For preferring or not preferring same-day bilateral injections from the patient's perspective

    Measured: Through study completion, an average of 9 months

  2. Differences in patient characteristics

    Between preference groups in: Age, Sex, Previous injection count, Indication for intravitreal treatment (medical diagnosis), Complications of previous treatments, Ocular comorbidity (e.g. glaucoma, cataract, previous retinal detachment etc.), Systemic comorbidity

    Measured: Through study completion, an average of 9 months

  3. Differences in socio-economic variables between preference groups

    As in: Need for caregivers, Means of transportation, Transport distance, Active vs retired, Highest education level

    Measured: Through study completion, an average of 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2025
  2. Study start13 Jan 2025
  3. Primary completionDec 2025 (estimated)
  4. Study completionJan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06894017
Sponsor's protocol ID
p-2024-16883
Status last verified
Jul 2025
First submitted
17 Mar 2025
Last updated
24 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36754539

  • 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.

    PubMed 37552956

  • 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.

    PubMed 29155696

  • 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.

    PubMed 36378615

  • 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.

    PubMed 35859120

  • 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.

    PubMed 21187731

  • 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.

    PubMed 35467755

  • 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.

    PubMed 23363080

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

Questions about this trial

What is this clinical trial studying?

An observational study of Informed Consent and Preference, Patient, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 24 Jul 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 Denmark. 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. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lena Michelle Mørup Andersen, MScN (+4538634700, lena.michelle.moerup.andersen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preference to bilateral injections (time frame: Through study completion, an average of 9 months). 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 NCT06894017, which also lists 9 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 24 Jul 2025.

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