Chronic Diabetic Macular Oedema Considered Insufficiently Responsive to Available TherapiesIRISSNCT01998412
Iluvien Registry Safety Study
An observational study of Chronic Diabetic Macular Oedema Considered Insufficiently Responsive to Available Therapies, run by Alimera Sciences at 1 site in United States.
Trial summary
The study will include any patient treated with Iluvien at designated sites in European countries where marketing authorization has been granted in order to obtain broader safety and usage information. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Diabetic Macular Oedema Considered Insufficiently Responsive to Available Therapies
- How many people
- 559 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jan 2020
- How long will I take part?
- 5 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with vision impairment associated with chronic diabetic macular oedema considered insufficiently responsive to available therapies that were selected to be treated with an intravitreal implant of ILUVIEN.
Who may be able to join
- Any patient treated with Iluvien under this protocol will be included in the study.
Who cannot join
- Patients/Guardians who are unable to understand and sign the Informed Consent will be excluded from the study.
- Retrospective Enrollment Criteria
- Patients treated with ILUVIEN prior to study initiation may be included provided they satisfy the inclusion and exclusion criteria, where applicable, as well as, the following requirements:
- The site is allowed to enroll a patient who was treated with ILUVIEN no more than 36 months prior to bringing the patient in for their first study visit.
- The eligible patient must meet the data requirements as specified in the protocol, i.e., baseline data collected within 7 days prior to treatment with ILUVIEN and additional data subsequently collected approximately every 6 months thereafter until enrolment into the study.
- The eligible patient must be enrolled at least one year prior to the planned end of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Registry Study of the Safety of Iluvien® 190 Micrograms Intravitreal Implant in Applicator
The study will include any patient treated with Iluvien at designated sites in European countries where marketing authorization has been granted in order to obtain broader safety and usage information.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Diabetic Macular Oedema Considered Insufficiently Responsive to Available TherapiesStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 559 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Alimera Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998412
- Sponsor's protocol ID
- M-01-12-001
- Acronym
- IRISS
- Status last verified
- Mar 2019
- First submitted
- 20 Nov 2013
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Chakravarthy U, Taylor SR, Koch FHJ, Castro de Sousa JP, Bailey C; ILUVIEN Registry Safety Study (IRISS) Investigators Group. Changes in intraocular pressure after intravitreal fluocinolone acetonide (ILUVIEN): real-world experience in three European countries. Br J Ophthalmol. 2019 Aug;103(8):1072-1077. doi: 10.1136/bjophthalmol-2018-312284. Epub 2018 Sep 21.
PubMed 30242062
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Registry Study of the Safety of Iluvien® 190 Micrograms Intravitreal Implant in Applicator
- ClinicalTrials.gov ID
- NCT01998412
- Acronym / sponsor ID
- IRISS / M-01-12-001
- Conditions
- Chronic Diabetic Macular Oedema Considered Insufficiently Responsive to Available Therapies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 559 participants (actual)
- Lead sponsor
- Alimera SciencesIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 28 Nov 2013 (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.
The study will include any patient treated with Iluvien at designated sites in European countries where marketing authorization has been granted in order to obtain broader safety and usage information.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with vision impairment associated with chronic diabetic macular oedema considered insufficiently responsive to available therapies that were selected to be treated with an intravitreal implant of ILUVIEN.
Key inclusion criteria (1 listed)
- Any patient treated with Iluvien under this protocol will be included in the study.
Key exclusion criteria (6 listed)
- Patients/Guardians who are unable to understand and sign the Informed Consent will be excluded from the study.
- Retrospective Enrollment Criteria
- Patients treated with ILUVIEN prior to study initiation may be included provided they satisfy the inclusion and exclusion criteria, where applicable, as well as, the following requirements:
- The site is allowed to enroll a patient who was treated with ILUVIEN no more than 36 months prior to bringing the patient in for their first study visit.
- The eligible patient must meet the data requirements as specified in the protocol, i.e., baseline data collected within 7 days prior to treatment with ILUVIEN and additional data subsequently collected approximately every 6 months thereafter until enrolment into the study.
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
Number of participants with adverse events.
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Results publication: PubMed 30242062Chakravarthy U, Taylor SR, Koch FHJ, Castro de Sousa JP, Bailey C; ILUVIEN Registry Safety Study (IRISS) Investigators Group. Changes in intraocular pressure after intravitreal fluocinolone acetonide (ILUVIEN): real-world experience in three European countries. Br J Ophthalmol. 2019 Aug;103(8):1072-1077. doi: 10.1136/bjophthalmol-2018-312284. Epub 2018 Sep 21.
- Changes in intraocular pressure after intravitreal fluocinolone acetonide (ILUVIEN): real-world experience in three European countriesLink provided by the sponsor.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chronic Diabetic Macular Oedema Considered Insufficiently Responsive to Available Therapies, run by Alimera Sciences at 1 site in United States.
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 1 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: status not confirmed, as of the sponsor's last update on 20 Mar 2019. 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 United States. 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?
Results are not available in the source record.
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?
Number of participants with adverse events. (time frame: 5 years). 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 NCT01998412, which also lists 1 linked publication.
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 20 Mar 2019.