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NCT03590587 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design

Related Conditions & MeSH terms

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
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