Evaluation of Macular Edema After AcF Implant's Injection, 1 Month After the Last DXM Implant

Macular Edema Clinical Trial

— ILUV1MOIS2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05996822
• Other study ID #: AP_JBD_002
• Status: Recruiting
• Start date: January 9, 2024
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: Nantes University Hospital
• Contact: Jean-Baptiste Ducloyer, M.D
• Phone: 0253482857
• Email: jeanbaptiste.ducloyer[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Macular Edema

Intervention

Drug:
• ACF injection
AcF injection 1 month after a DXM injection

Locations

Country	Name	City	State
France	Jean-Baptiste Ducloyer	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficiency (ETDRS)	change in visual acuity by ETDRS between baseline(before AcF injection) and 1 month after	1 month after AcF injection
Secondary	Efficiency (OCT)	change in macular thickness by OCT between baseline(before AcF injection) and 1 month after	1 month after AcF injection
Secondary	safety (AE)	Report of the adverse events during 1 month after ACF injection	1 month after AcF injection