Diabetic Macular EdemaPhase 4RESPONDNCT02359526
A Pilot Study on the Effect and Safety of Iluvien® in Chronic Diabetic Macular Edema Patients
A Phase 4 study testing IlUVIEN in people with Diabetic Macular Edema, run by Association for Innovation and Biomedical Research on Light and Image at 4 sites in Portugal.
Trial summary
To provide treating physicians with experience with ILUVIEN as well as monitoring its safety (and effectiveness) in a real-life chronic diabetic macular edema (DME) patients judged insufficiently responsive to available therapies. 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?
- IlUVIEN
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesPortugal
- Study dates
- Oct 2014to Dec 2016
- 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
- Adults (≥18 years) with chronic DME;
- Patients considered as insufficiently responsive as defined as having underwent other previous treatments, including at least 3 anti-VEGF injections in the last 6 months, and the following:
- Mean central foveal thickness (central subfield thickness) ≥ 290 um in women and ≥ 305 um in men in Zeiss Cirrus OR ≥ 305 um in women and ≥ 320 um in men in Heidelberg Spectralis, in the study eye as measured using SD-OCT;
- Vision impairment (20/50 to 20/400 using Snellen visual acuity equivalent) related to DME;
- If in the Investigator's opinion a further improvement is possible.
Who cannot join
- IOP > 21 mmHg at screening (day -14) in the study eye.
- Historical rise in IOP > 25 mmHg following treatment with an intravitreal corticosteroid in the study eye.
- Use of ≥ 2 active agents as IOP-lowering medications to control IOP at screening in the study eye.
- Vitreomacular traction in DME and opaque media in the study eye.
- Severe proliferative diabetic retinopathy requiring pan retinal photocoagulation in the study eye.
- Pregnant or breastfeeding women.
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- Active angiographic central macular ischaemia before baseline in the study eye.
- Pan retinal photocoagulation or cataract surgery 3 months before baseline in the study eye.
- Presence of pre-existing glaucoma, active or suspected ocular or periocular infection and/or hypersensitive to the active agent or to one of the excipients.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant UNLESS they are: using a highly effective method of birth control.
Trial locations and contacts
4 sites in 1 country.
Portugal4 sites
Center for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image
Coimbra, 3000-548
Instituto de Retina de Lisboa
Lisbon, 1050-085
Hospital de São João
Porto, 4200-319
Hospital Vila Franca Xira
Vila Franca de Xira, 2600-009
About this study
Official title: A Non-randomised, Open-label, Multicenter Phase 4 Pilot Study on the Effect and Safety of Iluvien® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies With or Without Intravitreal Corticosteroid Therapy (RESPOND)
To provide treating physicians with experience with ILUVIEN as well as monitoring its safety (and effectiveness) in a real-life chronic diabetic macular edema (DME) patients judged insufficiently responsive to available therapies.
- Conditions
- Diabetic Macular Edema
- Being tested
- IlUVIEN
- Keywords
- Chronic Diabetic Macular Edema, Iluvien, Intra-vitreal injections, Pilot study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IlUVIENDrug
Also called Fluocinolone Acetonide
All patients will receive ILUVIEN 190 micrograms intravitreal implant in applicator with an initial release rate of 0.2 microgram per day. The implant will be administered by injection according to the method of administration defined in the SmPC (ILUVIEN SmPC). Only one eye of each patient will be treated with ILUVIEN.
| Study group | Role | What they receive |
|---|---|---|
| ILUVIEN 190 ug intravitreal implant | Experimental | All patients will receive ILUVIEN 190 micrograms intravitreal implant in applicator with an initial release rate of 0.2 microgram per day. The implant will be administered by injection according to the method of administration defined in the SmPC (ILUVIEN SmPC). Only one eye of each patient will be treated with ILUVIEN. 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 (BCVA) from baseline to Month-12
Measured: Baseline to 12 months
Changes in central retinal thickness assessed using spectral domain optical coherence tomography (SD-OCT) from baseline to Month-12
Measured: Baseline to 12 months
Occurrence of Adverse events, namely cataract and elevated IOP
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startOct 2014
- Primary completionMar 2016
- Study completionDec 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and Image
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359526
- Sponsor's protocol ID
- 4C-2014-06
- Acronym
- RESPOND
- Status last verified
- Mar 2017
- First submitted
- 2 Feb 2015
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomised, Open-label, Multicenter Phase 4 Pilot Study on the Effect and Safety of Iluvien® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies With or Without Intravitreal Corticosteroid Therapy (RESPOND)
- ClinicalTrials.gov ID
- NCT02359526
- Acronym / sponsor ID
- RESPOND / 4C-2014-06
- Conditions
- Diabetic Macular Edema
- Keywords
- Chronic Diabetic Macular Edema, Iluvien, Intra-vitreal injections, Pilot study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and ImageUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Feb 2015 (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 provide treating physicians with experience with ILUVIEN as well as monitoring its safety (and effectiveness) in a real-life chronic diabetic macular edema (DME) patients judged insufficiently responsive to available therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ILUVIEN 190 ug intravitreal implant | Experimental | Drug: IlUVIENAll patients will receive ILUVIEN 190 micrograms intravitreal implant in applicator with an initial release rate of 0.2 microgram per day. The implant will be administered by injection according to the method of administration defined in the SmPC (ILUVIEN SmPC). Only one eye of each patient will be treated with ILUVIEN. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (≥18 years) with chronic DME;
- Patients considered as insufficiently responsive as defined as having underwent other previous treatments, including at least 3 anti-VEGF injections in the last 6 months, and the following:
Key exclusion criteria (10 listed)
- IOP > 21 mmHg at screening (day -14) in the study eye.
- Historical rise in IOP > 25 mmHg following treatment with an intravitreal corticosteroid in the study eye.
- Use of ≥ 2 active agents as IOP-lowering medications to control IOP at screening in the study eye.
- Vitreomacular traction in DME and opaque media in the study eye.
- 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 |
|---|---|---|
| IlUVIENAlso: Fluocinolone AcetonideAll patients will receive ILUVIEN 190 micrograms intravitreal implant in applicator with an initial release rate of 0.2 microgram per day. The implant will be administered by injection according to the method of administration defined in the SmPC (ILUVIEN SmPC). Only one eye of each patient will be treated with ILUVIEN. | Drug | ILUVIEN 190 ug intravitreal implant |
Primary outcome
Changes in best-corrected visual acuity (BCVA) from baseline to Month-12
Time frame: Baseline to 12 months
Changes in central retinal thickness assessed using spectral domain optical coherence tomography (SD-OCT) from baseline to Month-12
Time frame: Baseline to 12 months
Occurrence of Adverse events, namely cataract and elevated IOP
Time frame: 12 months
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 10 Mar 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IlUVIEN in people with Diabetic Macular Edema, run by Association for Innovation and Biomedical Research on Light and Image at 4 sites in Portugal.
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 10 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 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in 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?
Changes in best-corrected visual acuity (BCVA) from baseline to Month-12 (time frame: Baseline to 12 months). The study lists 3 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 10 Mar 2017.