Macular EdemaILUV1MOIS2NCT05996822
Evaluation of Macular Edema After AcF Implant's Injection, 1 Month After the Last DXM Implant
An observational study of Macular Edema, run by Nantes University Hospital at 1 site in France.
Trial summary
Patients with diabetic macular edema (DME) or uveitis-related macular edema who have failed first-line therapy such as anti-VEGF, laser treatments, or dexamethasone implants (DXM) are candidates for treatment with an intravitreal injection of a fluocinolone acetonide (AcF) implant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema
- What is being tested?
- ACF injection
- Type of treatment
- Injection or infusion
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2024to Jun 2024
- 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: Participants recruited in the study extension will be the same as those in the initial ILUV1MOIS study. The investigators will present the study extension to the patients at their scheduled routine care visits.
Who may be able to join
- Patient (Male, Female)°≥ 18 years old
- Having received an AcF injection 1 month after a DXM injection
- For diabetic macular edema or uveitic macular edema
Who cannot join
- Patient's refusal to allow his or her medical data to be used for research purposes
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Jean-Baptiste Ducloyer
Nantes, 44093
jean-Baptiste Ducloyer, MD, 02 40 08 34 01
About this study
Official title: Evaluation of Diabetic or Uveitic Macular Edema After Injection of a Fluocinolone Acetonide (AcF) Implant 1 Month After the Last Dexamethasone (DXM) Implant: Evaluation at 3 Years
Patients with diabetic macular edema (DME) or uveitis-related macular edema who have failed first-line therapy such as anti-VEGF, laser treatments, or dexamethasone implants (DXM) are candidates for treatment with an intravitreal injection of a fluocinolone acetonide (AcF) implant. AcF is unique in that it delivers intravitreal corticosteroids for 2 to 3 years, whereas DXM only releases them for 3 to 6 months. After 6 months for AcF and 1 month for DXM, full therapeutic efficacy is attained.
AcF's safety and efficacy have now been confirmed in the FAME originator studies as well as other phase IV investigations. However, in the FAME princeps trials and numerous phase IV trials where patients got AcF more than 6 months after DXM, up to 40% of patients required laser, anti-VEGF, and/or DXM retreatment within the AcF active period. This high rate could be attributed to AcF's 6-month delay in reaching full efficacy.
Read more
This is why the investigators intended to replicate the previous Iluvi1-month research, which shown that injecting DXM at 1 month preserved visual acuity and central retinal thickness for the first 6 months without increasing intraocular pressure significantly. The study, however, was unable to determine the long-term impact on the rate of relapses requiring additional therapy as well as tolerance with the development of long-term cortisone-induced glaucoma.
In light of this, the investigators should like to gather new data for a 3-year follow-up after AcF injection, including measurements of optic nerve fibre thickness (OCT RNFL). This is an essential safety data point because it assesses the long-term effects of ocular hypertension, which is a well-known side effect of intravitreal corticosteroids.
- Conditions
- Macular Edema
- Being tested
- ACF injection
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACF injectionDrug
AcF injection 1 month after a DXM injection
| Study group | Role | What they receive |
|---|---|---|
| AcF injection | Patient having received an AcF injection 1 month after a DXM injection for the treatment of Diabetic Macular Edema or Uveitic Macular Edema Receives: Drug: ACF injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficiency (ETDRS)
change in visual acuity by ETDRS between baseline(before AcF injection) and 1 month after
Measured: 1 month after AcF injection
Secondary outcomes (2)
Efficiency (OCT)
change in macular thickness by OCT between baseline(before AcF injection) and 1 month after
Measured: 1 month after AcF injection
safety (AE)
Report of the adverse events during 1 month after ACF injection
Measured: 1 month after AcF injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start9 Jan 2024
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular EdemaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996822
- Sponsor's protocol ID
- AP_JBD_002
- Acronym
- ILUV1MOIS2
- Status last verified
- Feb 2024
- First submitted
- 10 Aug 2023
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diabetic or Uveitic Macular Edema After Injection of a Fluocinolone Acetonide (AcF) Implant 1 Month After the Last Dexamethasone (DXM) Implant: Evaluation at 3 Years
- ClinicalTrials.gov ID
- NCT05996822
- Acronym / sponsor ID
- ILUV1MOIS2 / AP_JBD_002
- Conditions
- Macular Edema
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 18 Aug 2023 (actual)
- 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.
Patients with diabetic macular edema (DME) or uveitis-related macular edema who have failed first-line therapy such as anti-VEGF, laser treatments, or dexamethasone implants (DXM) are candidates for treatment with an intravitreal injection of a fluocinolone acetonide (AcF) implant. AcF is unique in that it delivers intravitreal corticosteroids for 2 to 3 years, whereas DXM only releases them for 3 to 6 months. After 6 months for AcF and 1 month for DXM, full therapeutic efficacy is attained.
AcF's safety and efficacy have now been confirmed in the FAME originator studies as well as other phase IV investigations. However, in the FAME princeps trials and numerous phase IV trials where patients got AcF more than 6 months after DXM, up to 40% of patients required laser, anti-VEGF, and/or DXM retreatment within the AcF active period. This high rate could be attributed to AcF's 6-month delay in reaching full efficacy.
This is why the investigators intended to replicate the previous Iluvi1-month research, which shown that injecting DXM at 1 month preserved visual acuity and central retinal thickness for the first 6 months without increasing intraocular pressure significantly. The study, however, was unable to determine the long-term impact on the rate of relapses requiring additional therapy as well as tolerance with the development of long-term cortisone-induced glaucoma.
In light of this, the investigators should like to gather new data for a 3-year follow-up after AcF injection, including measurements of optic nerve fibre thickness (OCT RNFL). This is an essential safety data point because it assesses the long-term effects of ocular hypertension, which is a well-known side effect of intravitreal corticosteroids.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AcF injection | – | Drug: ACF injectionPatient having received an AcF injection 1 month after a DXM injection for the treatment of Diabetic Macular Edema or Uveitic Macular Edema |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants recruited in the study extension will be the same as those in the initial ILUV1MOIS study. The investigators will present the study extension to the patients at their scheduled routine care visits.
Key inclusion criteria (3 listed)
- Patient (Male, Female)°≥ 18 years old
- Having received an AcF injection 1 month after a DXM injection
- For diabetic macular edema or uveitic macular edema
Key exclusion criteria (1 listed)
- Patient's refusal to allow his or her medical data to be used for research purposes
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 |
|---|---|---|
| ACF injectionAcF injection 1 month after a DXM injection | Drug | AcF injection |
Primary outcome
Efficiency (ETDRS)
Time frame: 1 month after AcF injection
change in visual acuity by ETDRS between baseline(before AcF injection) and 1 month after
2 secondary outcomes
Efficiency (OCT)
Time frame: 1 month after AcF injection
safety (AE)
Time frame: 1 month after AcF injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 Macular Edema, run by Nantes University Hospital at 1 site in France.
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 3 inclusion and 1 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 15 Feb 2024. 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 France. 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?
Contact Jean-Baptiste Ducloyer, M.D (0253482857, jeanbaptiste.ducloyer@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficiency (ETDRS) (time frame: 1 month after AcF injection). 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 15 Feb 2024.