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

NCT05996822 | Recruiting

• 1 other identifier: AP_JBD_002
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Edema

Outcome Measures

Primary Outcomes (1)

• Efficiency (ETDRS)

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

  1 month after AcF injection

Secondary Outcomes (2)

• Efficiency (OCT)

  1 month after AcF injection

• safety (AE)

  1 month after AcF injection

Study Arms (1)

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

Interventions

ACF injection DRUG

AcF injection 1 month after a DXM injection

AcF injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Jean-Baptiste Ducloyer

Nantes, 44093, France

RECRUITING

MeSH Terms

Conditions

Macular Edema

Interventions

A1CF protein, human

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Central Study Contacts

Jean-Baptiste Ducloyer, M.D

CONTACT

0253482857; jeanbaptiste.ducloyer@chu-nantes.fr

Alexandra Poinas

CONTACT

0253482857; alexandra.poinas@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 18, 2023
• Study Start: January 9, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: February 15, 2024

Record last verified: 2024-02

Locations

FR (1)