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

Diabetic Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03590587
• Other study ID #: skmc
• Status: Recruiting
• Start date: January 13, 2017
• Est. completion date: September 16, 2018

Study information

• Verified date: July 2018
• Source: Benha University
• Contact: Ahmed Elbarky, MD
• Phone: 00971557443731
• Email: AHMED.ALBARQY[@]fmed.bu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 16, 2018
• Est. primary completion date: September 15, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• DME

• Pseudophakic

Exclusion Criteria:

• Other causes of macular edema.

• Phakic

• Know case of gaucoma

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

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

Locations

Country	Name	City	State
United Arab Emirates	Shiekh Khalifa medical city	Abu Dhabi

Sponsors (2)

Lead Sponsor	Collaborator
Benha University	Sheikh Khalifa Medical City

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BCVA	best corrected visual acuity	12 months
Secondary	CMT	Central Macular thickness	12 months
Secondary	IOP	Intraocular pressure	12 months