Chronic Diabetic Macular EdemaPhase 4NCT02472366
A Non-Randomized, Open-Label, Single Center Phase 4 Study of the Effect and Safety of ILUVIEN® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies (Laser, Anti-VEGF) With or Without Intravitreal Corticosteroid Therapy
A Phase 4 study testing ILUVIEN in people with Chronic Diabetic Macular Edema, run by Alimera Sciences.
Trial summary
A phase 4 trial evaluating the effect and safety of ILUVIEN in chronic DME patients insufficiently responsive to available therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Diabetic Macular Edema
- What is being tested?
- ILUVIEN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to May 2015
- Phase
- Phase 4
- 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
Who may be able to join
- Patients ≥18 years of age, of either sex that have signed informed consent / been well informed by the treating physician.
- DME based on investigator's clinical evaluation and demonstrated using fundoscopic photography and spectral domain OCT.
- Mean central foveal thickness (central subfield thickness) ≥350 microns in the study eye as measured using spectral domain OCT.
- Vision impairment (20/60 to 20/400 using Snellen visual acuity equivalent) related to DME.
- Previous treatment in the study eye with laser photocoagulation for DME, including focal/grid and pan-retinal, at least 3 months prior to the screening visit and ≥3 monthly anti-VEGF treatments (group 1).
- Previous treatment in the study eye with laser photocoagulation for DME at least 3 months prior to the screening visit (group 2) and treatment with an intraocular anti-VEGF therapy not possible.
- Patients considered as insufficiently responsive to prior therapy for DME, as defined by the study physician.
Who cannot join
- IOP >21 mmHg at screening in the study eye.
- Historical rise in IOP >25 mmHg following treatment with an intravitreal corticosteroid in the study eye.
- Use of ≥2 IOP-lowering medications to control IOP at screening in the study eye.
- Patients that have vitreomacular traction in DME and opaque media in the study eye.
- Patients with severe proliferative diabetic retinopathy requiring pan retinal photocoagulation in the study eye.
- Pregnant or breastfeeding.
Show all 12Show fewer
- Patients diagnosed with active angiographic central vein ischaemia prior to screening in the study eye.
- Patients that have received pan retinal photocoagulation or undergone cataract surgery in the 3 months prior to the study start date in the study eye.
- Patients with contraindications according to the current 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.
About this study
A phase 4 trial evaluating the effect and safety of ILUVIEN in chronic DME patients insufficiently responsive to available therapies.
- Conditions
- Chronic Diabetic Macular Edema
- Being tested
- ILUVIEN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ILUVIENDrug
| Study group | Role | What they receive |
|---|---|---|
| laser | Other | laser with or without prior history of intraocular corticosteroid therapy Receives: Drug: ILUVIEN |
| laser and anti-VEGF | Other | laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy Receives: Drug: ILUVIEN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Best Corrected Visual Acuity From Baseline
Best Corrected Visual Acuity is measured using an ETDRS eye chart and is reported as the number of letters read correctly in the study and/or fellow eye.
Measured: Change from Baseline to 12 months post ILUVIEN administration
Secondary outcomes (3)
Changes in Intraocular Pressure (IOP)
Measured: Change from Baseline to 12 months post ILUVIEN administration
Changes in Central Subfield Thickness
Measured: Change from Baseline to 12 months post ILUVIEN administration
Changes in Macular Volume
Measured: Change from Baseline to 12 months post ILUVIEN administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startJan 2014
- Primary completionMar 2015
- Study completionMay 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 Chronic 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alimera Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02472366
- Sponsor's protocol ID
- M-01-13-002
- Status last verified
- Aug 2015
- First submitted
- 10 Jun 2015
- Last updated
- 16 Sep 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 16 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Randomized, Open-Label, Single Center Phase 4 Study of the Effect and Safety of ILUVIEN® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies (Laser, Anti-VEGF) With or Without Intravitreal Corticosteroid Therapy
- ClinicalTrials.gov ID
- NCT02472366
- Acronym / sponsor ID
- M-01-13-002
- Conditions
- Chronic Diabetic Macular Edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Alimera SciencesIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 15 Jun 2015 (estimated)
- Results
- Posted 16 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase 4 trial evaluating the effect and safety of ILUVIEN in chronic DME patients insufficiently responsive to available therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laser | Other | Drug: ILUVIENlaser with or without prior history of intraocular corticosteroid therapy |
| laser and anti-VEGF | Other | Drug: ILUVIENlaser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients ≥18 years of age, of either sex that have signed informed consent / been well informed by the treating physician.
- DME based on investigator's clinical evaluation and demonstrated using fundoscopic photography and spectral domain OCT.
- Mean central foveal thickness (central subfield thickness) ≥350 microns in the study eye as measured using spectral domain OCT.
- Vision impairment (20/60 to 20/400 using Snellen visual acuity equivalent) related to DME.
- Previous treatment in the study eye with laser photocoagulation for DME, including focal/grid and pan-retinal, at least 3 months prior to the screening visit and ≥3 monthly anti-VEGF treatments (group 1).
Key exclusion criteria (12 listed)
- IOP >21 mmHg at screening in the study eye.
- Historical rise in IOP >25 mmHg following treatment with an intravitreal corticosteroid in the study eye.
- Use of ≥2 IOP-lowering medications to control IOP at screening in the study eye.
- Patients that have vitreomacular traction in DME and opaque media in the study eye.
- Patients with severe proliferative diabetic retinopathy requiring pan retinal photocoagulation in the study eye.
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 |
|---|---|---|
| ILUVIEN | Drug | laser, laser and anti-VEGF |
Primary outcome
Changes in Best Corrected Visual Acuity From Baseline
Time frame: Change from Baseline to 12 months post ILUVIEN administration
Best Corrected Visual Acuity is measured using an ETDRS eye chart and is reported as the number of letters read correctly in the study and/or fellow eye.
3 secondary outcomes
Changes in Intraocular Pressure (IOP)
Time frame: Change from Baseline to 12 months post ILUVIEN administration
Changes in Central Subfield Thickness
Time frame: Change from Baseline to 12 months post ILUVIEN administration
Changes in Macular Volume
Time frame: Change from Baseline to 12 months post ILUVIEN administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Chronic Diabetic Macular Edema
Not yet recruiting
Effectiveness of Multidisciplinary Protocolised Interventions on IVT Non-adherence Rates
Diabetic Macular Edema, Neovascular (Wet) Age-Related Macular Degeneration
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ILUVIEN in people with Chronic Diabetic Macular Edema, run by Alimera Sciences.
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 12 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 16 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 16 Sep 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?
Changes in Best Corrected Visual Acuity From Baseline (time frame: Change from Baseline to 12 months post ILUVIEN administration). 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 16 Sep 2015.