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

Recruiting

• Conditions: Macular Edema
• Interventions: Drug: ACF injection

• Registration Number: NCT05996822
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-10
• Study First Submitted QC: 2023-08-10
• Study First Posted: 2023-08-18
• Study Start: 2024-01-09
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-15
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AcF injection	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

Primary Outcome Measures

Name	Time	Method
Efficiency (ETDRS)	1 month after AcF injection	change in visual acuity by ETDRS between baseline(before AcF injection) and 1 month after

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Jean-Baptiste Ducloyer; 🇫🇷 Nantes, France