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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

B

Benha University

Status

Unknown

Conditions

Diabetic Macular Edema

Treatments

Device: 0.19 mg fluocinolone acetonide (FAc) implant

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • DME
  • Pseudophakic

Exclusion criteria

  • Other causes of macular edema.
  • Phakic
  • Know case of gaucoma

Trial design

30 participants in 1 patient group

1
Description:
patients treated with 0.19 mg fluocinolone acetonide (FAc) implant for 12 months
Treatment:
Device: 0.19 mg fluocinolone acetonide (FAc) implant
Device: 0.19 mg fluocinolone acetonide (FAc) implant

Trial contacts and locations

1

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Central trial contact

Elbarky, MD; Ahmed Elbarky, MD

Data sourced from clinicaltrials.gov

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