Diabetic Macular EdemaARTESNCT02121197
Retrospective Trial on the Efficacy and Safety of Intravitreal Ozurdex in Patients With Diabetic Macular Edema.
An observational study of Diabetic Macular Edema, run by Association for Innovation and Biomedical Research on Light and Image at 25 sites in 8 countries.
Trial summary
To review the safety and efficacy of injections with Ozurdex (700 μg dexamethasone) in clinical practice management of patients with DME. 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?
- Ozurdex
- How many people
- 321 participants
- Where
- 25 sitesin 8 countries
- Study dates
- Aug 2014to Jan 2016
- Phase
- Observational
- 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
Study population: 300-400 patients who have received at least 2 Ozurdex injections for the treatment of DME, were followed for at least 6 months after the last injection and with a minimal BCVA of 20/200 at baseline (before Ozurdex treatment).
Who may be able to join
- Adults (≥18 years) with diabetes
- DME in the study eye (if both eyes have DME both eyes will be included in analysis)
- BCVA minimum of 20/200 (35 letters)
- Central Macular Thickness (CMT) ≥300 µm
- Patients with DME who were treated with Ozurdex at least twice (baseline is before the first Ozurdex injection).
- Follow up of at least 6 months after the last Ozurdex injection given
- Complete records including BCVA (OCT and Fluorescein Angiography (FA) if available) throughout the follow up
Who cannot join
- Patients with ME not secondary to Diabetes Mellitus (DM).
- Presence of other retinopathies (AMD, RVO) or visually significant ocular morbidity (e.g. advanced glaucoma, corneal opacity)
- Previous ocular trauma or surgery other than cataract extraction
- Intravitreal triamcinolone ≤6 months before baseline
- Intravitreal bevacizumab, ranibizumab, or pegaptanib <1 months before baseline
- Marked intraocular pressure (IOP) elevation in response to any previous steroid treatment
Show all 11Show fewer
- Ocular Hypertension (OHT) in the study eye(s)
- IOP >23 mm Hg without antiglaucoma medication
- IOP >21 mm Hg with one antiglaucoma medication
- Use of 2 or more antiglaucoma medications
- Glaucoma - Visual Fields (VF) defect > 4 dB
Trial locations and contacts
25 sites in 8 countries.
25 sites in 8 countries
Italy6 sites
Ophthalmic Research Unit, Department of Basic Medical Sciences, Neuroscience and Sense Organs
Bari, 7012
Excellence Eye Research Centre University G. d'Annunzio of Chieti-Pescara
Chieti, 66100
Department of Ophthalmology University Vita Salute - Scientific Institute of San Raffael
Milan, 20132
Centre for Clinical Trials, Department of Ophthalmology University of Padova
Padova, 35128
G.B.Bietti Eye Foundation - IRCCS
Rome, 00198
Department of Ophthalmology University of Udine
Udine, 33100
Spain6 sites
Ophthalmology Department, Dos de Maig Hospital
Barcelona, 08025
Hospital Vall d'Hebrón Department of Ophthalmology
Barcelona, 08035
Instituto de Microcirugia Ocular
Barcelona, 08035
Vallés Oftalmologia Research
Barcelona, 08195
Ophthalmology Department, Hospital de LaPaz
Madrid, 28046
Servicio de Oftalmologia, Hospital Universitario Y Politecnico de la Fe
Valencia, 460
France5 sites
Department of Ophthalmology, Centre Hospitalier Henri Duffaut,
Avignon, 84902
Department of Ophthalmology, Croix Rousse University Hospital
Lyon, 69004
Clinical Trial Unit, Department of Ophthalmology, CHU Nord, Aix Marseille University
Marseille, 13015
Coscas Eye Clinic
Paris, 75006
Department of Ophthalmology Lariboisière Hospital
Paris, 75475
Israel2 sites
Ophthalmology Department, Kaplan Medical Center
Rehovot, 76100
Department of Ophthalmology Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Portugal2 sites
Center for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image
Coimbra, 3000-548
Instituto de Retina e Diabetes Ocular de Lisboa (IRL)
Lisbon, 1050-085
United Kingdom2 sites
Ophthalmology Clinical Trials Unit Frimley Park Hospital Foundation Trust
Frimley, GU16 7UJ
NIHR Moorfields Clinical Research Facility, Moorfields Eye Hospital, NHS Foundation Trust
London, EC1V 2PD
Finland1 site
Department of Ophthalmology, Kuopio University Hospital
Kuopio, 70211
About this study
Official title: A Collaborative Retrospective Trial on the Efficacy and Safety of Intravitreal Dexamethasone Implant (Ozurdex) in Patients With Diabetic Macular Edema (DME). THE EUROPEAN DME REGISTRAR STUDY (ARTES)
To review the safety and efficacy of injections with Ozurdex (700 μg dexamethasone) in clinical practice management of patients with DME.
- Conditions
- Diabetic Macular Edema
- Being tested
- Ozurdex
- Keywords
- Macular Diabetic Edema, Ozurdex, Retrospective, European, Intra-vitreal injections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzurdexDrug
Also called Dexamethasone
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with Best Corrected Visual Acuity (BCVA) from baseline to 4 - 6 months after last injection, with comparison between early (<9 month duration of DME) vs late (≥9 month duration of DME), and naïve vs previously treated patients.
Percentage of patients with Best Corrected Visual Acuity (BCVA) from baseline to 4 - 6 months after last injection, with comparison between early (<9 month duration of DME) vs late (≥9 month duration of DME), and naïve vs previously treated patients.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startAug 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and Image
- Sponsor type
- University, hospital or other
- Collaborators
- European Vision Institute Clinical Research Network
- Responsible party
- Sponsor
- Investigators
- Anat Loewenstein, Professor, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121197
- Sponsor's protocol ID
- ECR-RET-2014-07
- Acronym
- ARTES
- Status last verified
- May 2018
- First submitted
- 22 Apr 2014
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Collaborative Retrospective Trial on the Efficacy and Safety of Intravitreal Dexamethasone Implant (Ozurdex) in Patients With Diabetic Macular Edema (DME). THE EUROPEAN DME REGISTRAR STUDY (ARTES)
- ClinicalTrials.gov ID
- NCT02121197
- Acronym / sponsor ID
- ARTES / ECR-RET-2014-07
- Conditions
- Diabetic Macular Edema
- Keywords
- Macular Diabetic Edema, Ozurdex, Retrospective, European, Intra-vitreal injections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and ImageUniversity, hospital or other
- Collaborators
- European Vision Institute Clinical Research Network
- Study start
- Aug 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 23 Apr 2014 (estimated)
- 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.
To review the safety and efficacy of injections with Ozurdex (700 μg dexamethasone) in clinical practice management of patients with DME.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 300-400 patients who have received at least 2 Ozurdex injections for the treatment of DME, were followed for at least 6 months after the last injection and with a minimal BCVA of 20/200 at baseline (before Ozurdex treatment).
Key inclusion criteria (7 listed)
- Adults (≥18 years) with diabetes
- DME in the study eye (if both eyes have DME both eyes will be included in analysis)
- BCVA minimum of 20/200 (35 letters)
- Central Macular Thickness (CMT) ≥300 µm
- Patients with DME who were treated with Ozurdex at least twice (baseline is before the first Ozurdex injection).
Key exclusion criteria (11 listed)
- Patients with ME not secondary to Diabetes Mellitus (DM).
- Presence of other retinopathies (AMD, RVO) or visually significant ocular morbidity (e.g. advanced glaucoma, corneal opacity)
- Previous ocular trauma or surgery other than cataract extraction
- Intravitreal triamcinolone ≤6 months before baseline
- Intravitreal bevacizumab, ranibizumab, or pegaptanib <1 months before baseline
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 |
|---|---|---|
| OzurdexAlso: Dexamethasone | Drug | – |
Primary outcome
Percentage of patients with Best Corrected Visual Acuity (BCVA) from baseline to 4 - 6 months after last injection, with comparison between early (<9 month duration of DME) vs late (≥9 month duration of DME), and naïve vs previously treated patients.
Time frame: 6 month
Percentage of patients with Best Corrected Visual Acuity (BCVA) from baseline to 4 - 6 months after last injection, with comparison between early (<9 month duration of DME) vs late (≥9 month duration of DME), and naïve vs previously treated patients.
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 21 May 2018.
Related trials for Diabetic Macular Edema
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME
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.
Anat Loewenstein, Professor principal investigator
Tel-Aviv Sourasky Medical Center
25 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Macular Edema, run by Association for Innovation and Biomedical Research on Light and Image at 25 sites in 8 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 7 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 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Italy, Spain, France, Israel, Portugal and 3 more countries. 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?
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?
Percentage of patients with Best Corrected Visual Acuity (BCVA) from baseline to 4 - 6 months after last injection, with comparison between early (<9 month duration of DME) vs late (≥9 month duration of DME), and naïve vs previously treated patients. (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2018.