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Diabetic Macular EdemaPhase 4EYEberiaNCT03953807

A Study to Evaluate the Effectiveness and Safety of OZURDEX® in Patients With Diabetic Macular Edema But Never Treated

A Phase 4 study testing Dexamethasone Intravitreal Implant in people with Diabetic Macular Edema, run by Allergan at 26 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate the efficacy and safety of OZURDEX in patients with Diabetic Macular Edema when used in a real world setting in Spain and Portugal. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Macular Edema
What is being tested?
Dexamethasone Intravitreal Implant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
26 sitesin 2 countries
Study dates
5 Sep 2019to 4 Jul 2022
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

  • Prior diagnosis of diabetes mellitus (type 1 or type 2)
  • Media clarity, pupillary dilation, and patient cooperation sufficient for all study procedures
  • Written informed consent obtained in accordance with all local privacy requirements

Who cannot join

  • Uncontrolled systemic disease
  • History of disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease condition that contraindicates the use of the investigational drug, might affect the interpretation of study results, or render the patient at high risk from treatment complications
  • Patients who have been previously treated for DME (two focal laser allowed)
  • Untreated diabetes or anticipated change (increase) of antidiabetic medications during the study
  • Elevated IOP or glaucoma diagnosis
  • Any active ocular infection or inflammation
Show all 11Show fewer
  • Aphakia
  • A substantial cataract is present that is likely to be decreasing visual acuity by three lines or more (i.e., cataract would be reducing visual acuity to 20/40 or worse if the eye was otherwise normal)
  • Anticipated need for ocular surgery during the study
  • History of vitrectomy or incisional glaucoma surgery - Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception
  • Known allergy, hypersensitivity or contraindication to the study medication, its components, or povidone iodine

Trial locations and contacts

26 sites in 2 countries.

26 sites in 2 countries

Spain20 sites

  • Centro de Oftalmología Barraquer /ID# 233591

    Barcelona, 08021

  • ICOF Hospital Clinic De Barcelona /ID# 233675

    Barcelona, 08028

  • Instituto de Microcirugía Ocular /ID# 233689

    Barcelona, 08035

  • Hospital Universitario de Cruces /ID# 233673

    Bilbao, 48903

  • Hospital Universitario Insular de Gran Canaria /ID# 233658

    Les Palma, 35016

  • Oftalvist Moncloa /ID# 233647

    Madrid, 28008

  • Vissum Madrid /ID# 233646

    Madrid, 28035

  • Hospital Clinico Universitario San Carlos /ID# 233578

    Madrid, 28040

  • Hospital Universitario La Paz /ID# 233619

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro, Majadahonda /ID# 233597

    Majadahonda, Madrid, 28222

  • Hospital Universitari Son Espases /ID# 233601

    Palma de Mallorca, Balearic Islands, 07120

  • CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 233618

    Pamplona, Navarre, 31008

  • Instituto Oftalmológico Gómez-Ulla /ID# 233590

    Santiago de Compostela, A Coruna, 15706

  • Hospital Universitario Virgen del Rocio /ID# 233609

    Seville, 41013

  • Hospital General Universitario de Valencia /ID# 233600

    Valencia, 46014

  • Hospital Universitario Arnau Vilanova /ID# 233594

    Valencia, 46015

  • Hospital Universitario y Politecnico La Fe /ID# 233613

    Valencia, 46026

  • Hospital Universitario de Araba /ID# 233693

    Vitoria-Gasteiz, 01004

  • Hospital Clinico Universitario Lozano Blesa /ID# 233685

    Zaragoza, 50009

  • Miguel Servet University Hospital /ID# 233629

    Zaragoza, 50009

Other trials in Spain

Portugal6 sites

  • Chuc /Id# 233643

    Coimbra, 3004-561

  • Hospital de Santo Andre /ID# 233670

    Leiria, 2410-197

  • IRL - Instituto de Retina e Diabetes Ocular de Lisboa /ID# 233667

    Lisbon, 1150-085

  • Centro Hospitalar de Lisboa Norte /ID# 233684

    Lisbon, 1649 028

  • Ulsam /Id# 233635

    Viana do Castelo, 4904-495

  • Hospital de Vila Franca de Xira /ID# 233682

    Vila Franca de Xira, 2600-009

Other trials in Portugal

About this study

Official title: A 12-month, Prospective, Open-label, Phase 4 Study to Evaluate the Efficacy and Safety of OZURDEX® (Dexamethasone Intravitreal Implant) in Treatment Naïve Patients (According to Standard Clinical Practice) With Diabetic Macular Edema

This study will evaluate the efficacy and safety of OZURDEX in patients with Diabetic Macular Edema when used in a real world setting in Spain and Portugal.

Being tested
Dexamethasone Intravitreal Implant

What participants receive

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

  • Dexamethasone Intravitreal ImplantDrug

    Implant 700 μg

Study groups in NCT03953807
Study groupRoleWhat they receive
OzurdexExperimentalOZURDEX implant 700 μg
Receives: Drug: Dexamethasone Intravitreal Implant

What is being measured

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

  1. Mean change in best corrected visual acuity (BCVA) 2 months (± 2 weeks) after the last injection

    Measured: Baseline, at Month 10 through 12

Secondary outcomes (10)

  1. Mean change in Central Retinal Thickness (CRT) 2 months (± 2 weeks) after the last injection received

    Measured: Baseline, at Month 10 through 12

  2. Mean retreatment interval in months

    Measured: During the 12 to 14-month study

  3. Area under the curve (AUC) for CRT

    Measured: Baseline, During the 12 to 14-month study

  4. AUC for BCVA

    Measured: Baseline, During the 12 to 14-month study

  5. Mean change in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25)

    25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better functioning. Original numeric values from the survey will be recoded with the worst and best possible scores set at 0 and 100 points, respectively. In this format, scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score.

    Measured: Baseline, at Month 14

  6. Proportion of patients with 2nd injection

    Measured: During the 12 to 14-month study

  7. Proportion of patients with 3rd injection

    Measured: During the 12 to 14-month study

  8. Mean number of injections administered

    Measured: During the 12- to 14-month study

  9. Time to 3rd injection

    Measured: During the 12 to 14-month study

  10. Time to 2nd injection

    Measured: During the 12 to 14-month study

Timeline

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

  1. First posted17 May 2019
  2. Study start5 Sep 2019
  3. Primary completion4 Jul 2022
  4. Study completion4 Jul 2022

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03953807
Sponsor's protocol ID
CMO-MA-EYE-0603
Other IDs
2018-004785-33, 2018
Acronym
EYEberia
Status last verified
Oct 2022
First submitted
13 May 2019
Last updated
7 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexamethasone Intravitreal Implant in people with Diabetic Macular Edema, run by Allergan at 26 sites in 2 countries.

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 3 inclusion and 11 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 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Spain, Portugal. 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.

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?

Mean change in best corrected visual acuity (BCVA) 2 months (± 2 weeks) after the last injection (time frame: Baseline, at Month 10 through 12). 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 NCT03953807.

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 7 Oct 2022.

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