Clinical trial NCT05996822: Evaluation of Macular Edema After AcF Implant's Injection, 1 Month After the Last DXM Implant
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Macular Edema
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patient's refusal to allow his or her medical data to be used for research purposes

Primary outcomes:
measure: Efficiency (ETDRS)
timeFrame: 1 month after AcF injection
Secondary outcomes:
measure: Efficiency (OCT)
timeFrame: 1 month after AcF injection
measure: safety (AE)
timeFrame: 1 month after AcF injection
Other outcomes:
Locations:
city: Nantes
country: France
facility: Jean-Baptiste Ducloyer
Study officials:
References: