NCT03590587

Rapid Structural and Functional Improvements in Following 0.19 mg Fluocinolone Acetonide (FAc) Implant in Diabetic Macular Edema Patients With Poor Visual Acuity: 12-month Audit Results From United Arab Emirates

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Benha University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The Health Authority - Abu Dhabi (HAAD) approved the reimbursement of the slow release FAc implant (ILUVIEN) and it is now available for the treatment of diabetic macular edema (DME) in persons who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. We performed a retrospective 12-month audit to assess the efficacy and safety of the FAc implant in our clinical practice.

Detailed description

Twenty patients with pseudophakic lenses, treated with ILUVIEN, were investigated to evaluate functional and anatomical characteristics and outcomes (visual acuity \[VA; ETDRS letters score\], central macular thickness \[CMT\] and intraocular pressure \[IOP\]) at baseline, weeks 2-4 and months 3, 6 and 12 months.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	0.19 mg fluocinolone acetonide (FAc) implant	0.19 mg fluocinolone acetonide (FAc) implant
DEVICE	0.19 mg fluocinolone acetonide (FAc) implant	0.19 mg fluocinolone acetonide (FAc) implant

Timeline

• Start date: 2017-01-13
• Primary completion: 2018-09-15
• Completion: 2018-09-16
• First posted: 2018-07-18
• Last updated: 2018-07-18

Locations

1 site across 1 country: United Arab Emirates

Regulatory

• FDA-regulated drug study
• FDA-regulated device study