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

NCT05996822 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 34

Last updated 2024-02-15

No results posted yet for this study

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

Interventions

DRUG

ACF injection

AcF injection 1 month after a DXM injection

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-09
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05996822 on ClinicalTrials.gov