Evaluation of Macular Edema After AcF Implant's Injection, 1 Month After the Last DXM Implant (ILUV1MOIS2)

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.

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 Overview

• Status: Recruiting
• Conditions: Macular Edema
• Intervention / Treatment: Drug: ACF injection

• Study Type: Observational
• Enrollment (Estimated): 34

Contacts and Locations

• Study Contact: Name: Jean-Baptiste Ducloyer, M.D; Phone Number: 0253482857; Email: jeanbaptiste.ducloyer@chu-nantes.fr
• Study Contact Backup: Name: Alexandra Poinas; Phone Number: 0253482857; Email: alexandra.poinas@chu-nantes.fr

Study Locations

• France
  • Nantes, France, 44093
    • Recruiting
    • Jean-Baptiste Ducloyer
    • Contact: jean-Baptiste Ducloyer, MD; Phone Number: 02 40 08 34 01

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: ACF injection; AcF injection 1 month after a DXM injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficiency (ETDRS)	change in visual acuity by ETDRS between baseline(before AcF injection) and 1 month after	1 month after AcF injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficiency (OCT)	change in macular thickness by OCT between baseline(before AcF injection) and 1 month after	1 month after AcF injection
safety (AE)	Report of the adverse events during 1 month after ACF injection	1 month after AcF injection

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: August 10, 2023
• First Submitted That Met QC Criteria: August 10, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema
• Other Study ID Numbers: AP_JBD_002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No