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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Jean-Baptiste Ducloyer
RECRUITING
Nantes
Contact Information
Primary
Jean-Baptiste Ducloyer, M.D
jeanbaptiste.ducloyer@chu-nantes.fr
0253482857
Backup
Alexandra Poinas
alexandra.poinas@chu-nantes.fr
0253482857
Time Frame
Start Date: 2024-01-09
Estimated Completion Date: 2024-06
Participants
Target number of participants: 34
Treatments
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
Sponsors
Leads: Nantes University Hospital

This content was sourced from clinicaltrials.gov