Diabetic Macular Edema (DME)ILUMINATENCT02080091
Observational Study to Assess the Effect of Iluvien® in DME Patients Insufficiently Responsive to Available Therapies
An observational study of Diabetic Macular Edema (DME), run by Alimera Sciences at 1 site in Germany.
Trial summary
This observational study aims to assess the safety and effect of Iluvien® in DME patients considered insufficiently responsive to available therapies in a real life setting in Germany. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema (DME)
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2013to Apr 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 with DME considered insufficiently responsive to available therapies in approximately 25 ophthalmology centers (private practice or hospital) across Germany
Who may be able to join
- Adult patients of both sexes that have signed informed consent after detailed information about the characteristics of the observation by the physician
- DME based on physician's clinical evaluation and demonstrated on fundus photographs and/or optical coherence tomography (OCT);
- Vision impairment associated with DME
- Prior treatment with available therapies for DME; and
- Patients considered by the physician insufficiently responsive to available therapies
Who cannot join
- Patients with contraindications according to the current Summary of Product Characteristics (SPC)
- The presence of pre-existing glaucoma
- Active or suspected ocular or periocular infection
- The patient is hypersensitive to the active agent or to one of the excipients
- Elevated IOP
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ILUMINATE: An Open-Label, Non-Interventional Study of the Safety and Effect of Iluvien® (Fluocinolone Acetonide 190 Micrograms Intravitreal Implant in Applicator) in Patients With Chronic Diabetic Macular Edema (DME) Insufficiently Responsive to Available Therapies
This observational study aims to assess the safety and effect of Iluvien® in DME patients considered insufficiently responsive to available therapies in a real life setting in Germany.
- Conditions
- Diabetic Macular Edema (DME)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic DME | Patients with vision impairment associated with chronic diabetic macular edema (DME) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Observed and change from baseline visual acuity LogMAR scores will be summarized using descriptive statistics.
Measured: 24 Months
Number of Patients With Ocular Adverse Events
Measured: 24 Months
Secondary outcomes (1)
Retinal Center Subfield Thickness
Observed and change from baseline SD-OCT values will be summarized using descriptive statistics.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startDec 2013
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Macular Edema (DME)Studies 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
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alimera Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Professor Helmut Hoeh, MD, Study chair, Dietrich-Bonhoeffer-Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080091
- Sponsor's protocol ID
- M-01-13-003
- Acronym
- ILUMINATE
- Status last verified
- Aug 2015
- First submitted
- 3 Mar 2014
- Last updated
- 26 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ILUMINATE: An Open-Label, Non-Interventional Study of the Safety and Effect of Iluvien® (Fluocinolone Acetonide 190 Micrograms Intravitreal Implant in Applicator) in Patients With Chronic Diabetic Macular Edema (DME) Insufficiently Responsive to Available Therapies
- ClinicalTrials.gov ID
- NCT02080091
- Acronym / sponsor ID
- ILUMINATE / M-01-13-003
- Conditions
- Diabetic Macular Edema (DME)
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Alimera SciencesIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 6 Mar 2014 (estimated)
- Results
- Posted 10 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study aims to assess the safety and effect of Iluvien® in DME patients considered insufficiently responsive to available therapies in a real life setting in Germany.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic DME | – | –Patients with vision impairment associated with chronic diabetic macular edema (DME) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with DME considered insufficiently responsive to available therapies in approximately 25 ophthalmology centers (private practice or hospital) across Germany
Key inclusion criteria (5 listed)
- Adult patients of both sexes that have signed informed consent after detailed information about the characteristics of the observation by the physician
- DME based on physician's clinical evaluation and demonstrated on fundus photographs and/or optical coherence tomography (OCT);
- Vision impairment associated with DME
- Prior treatment with available therapies for DME; and
- Patients considered by the physician insufficiently responsive to available therapies
Key exclusion criteria (6 listed)
- Patients with contraindications according to the current Summary of Product Characteristics (SPC)
- The presence of pre-existing glaucoma
- Active or suspected ocular or periocular infection
- The patient is hypersensitive to the active agent or to one of the excipients
- Elevated IOP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual Acuity
Time frame: 24 Months
Observed and change from baseline visual acuity LogMAR scores will be summarized using descriptive statistics.
Number of Patients With Ocular Adverse Events
Time frame: 24 Months
1 secondary outcome
Retinal Center Subfield Thickness
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Professor Helmut Hoeh, MD study chair
Dietrich-Bonhoeffer-Klinikum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Macular Edema (DME), run by Alimera Sciences at 1 site in Germany.
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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 26 Aug 2015. 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 Germany. 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?
Yes. Results are posted in the registry (first posted 10 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Acuity (time frame: 24 Months). The study lists 2 primary outcomes in all. 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 26 Aug 2015.