NCT03590587

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2018

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

1.7 years

First QC Date

July 7, 2018

Last Update Submit

July 7, 2018

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

  • BCVA

    best corrected visual acuity

    12 months

Secondary Outcomes (2)

  • CMT

    12 months

  • IOP

    12 months

Study Arms (1)

1

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

Drug: 0.19 mg fluocinolone acetonide (FAc) implantDevice: 0.19 mg fluocinolone acetonide (FAc) implant

Interventions

0.19 mg fluocinolone acetonide (FAc) implantDRUG

0.19 mg fluocinolone acetonide (FAc) implant

1

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • DME
  • Pseudophakic

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiekh Khalifa medical city

Abu Dhabi, 51900, United Arab Emirates

RECRUITING

MeSH Terms

Interventions

Fluocinolone AcetonideCAF protocolDrug ImplantsMutagenesis, Insertional

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedDelayed-Action PreparationsDosage FormsPharmaceutical PreparationsProtein EngineeringGenetic EngineeringGenetic TechniquesInvestigative TechniquesMutationGenetic VariationGenetic PhenomenaMutagenesis

Central Study Contacts

Ahmed Elbarky, MD

CONTACT

00971557443731AHMED.ALBARQY@fmed.bu.edu.eg

Elbarky, MD

CONTACT

00971557443731AHMED.ALBARQY@fmed.bu.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of ophthalmologyu

Study Record Dates

First Submitted

July 7, 2018

First Posted

July 18, 2018

Study Start

January 13, 2017

Primary Completion

September 15, 2018

Study Completion

September 16, 2018

Last Updated

July 18, 2018

Record last verified: 2018-07

Locations

AE(1)