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

NCT ID: NCT03590587

Last Updated: 2018-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-13

Study Completion Date

2018-09-16

Brief Summary

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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

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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

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Diabetic Macular Edema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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1

patients treated with 0.19 mg fluocinolone acetonide (FAc) implant for 12 months

0.19 mg fluocinolone acetonide (FAc) implant

Intervention Type DRUG

0.19 mg fluocinolone acetonide (FAc) implant

0.19 mg fluocinolone acetonide (FAc) implant

Intervention Type DEVICE

0.19 mg fluocinolone acetonide (FAc) implant

Interventions

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0.19 mg fluocinolone acetonide (FAc) implant

0.19 mg fluocinolone acetonide (FAc) implant

Intervention Type DRUG

0.19 mg fluocinolone acetonide (FAc) implant

0.19 mg fluocinolone acetonide (FAc) implant

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* DME
* Pseudophakic

Exclusion Criteria

* Other causes of macular edema.
* Phakic
* Know case of gaucoma
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheikh Khalifa Medical City

OTHER

Sponsor Role collaborator

Benha University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Elbarky

assistant professor of ophthalmologyu

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shiekh Khalifa medical city

Abu Dhabi, , United Arab Emirates

Site Status RECRUITING

Countries

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United Arab Emirates

Central Contacts

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Ahmed Elbarky, MD

Role: CONTACT

00971557443731 ext. 00971557443731

Elbarky, MD

Role: CONTACT

00971557443731 ext. 00971557443731

Facility Contacts

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Ahmed Elbarky

Role: primary

00971557443731 ext. 00971557443731

Other Identifiers

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skmc

Identifier Type: -

Identifier Source: org_study_id

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