Rapid Structural and Functional Improvements in Following... | NCT03590587

Studies
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

NCT03590587

Sponsor

Benha University

Status

Unknown status

Last Update Posted

Jul 18, 2018Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Diabetic Macular Edema

Interventions

0.19 mg fluocinolone acetonide (FAc) implant
0.19 mg fluocinolone acetonide (FAc) implant

Countries

United Arab Emirates

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 13, 2017Actual

Primary Completion Date

Sep 15, 2018Estimated

Completion Date

Sep 16, 2018Estimated

First Submitted Date

Jul 7, 2018

First Submission Date that Met QC Criteria

Jul 7, 2018

First Posted Date

Jul 18, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2018

Last Update Posted Date

Jul 18, 2018Actual

Name	Class
Sheikh Khalifa Medical City	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		patients treated with 0.19 mg fluocinolone acetonide (FAc) implant for 12 months	Drug: 0.19 mg fluocinolone acetonide (FAc) implant Device: 0.19 mg fluocinolone acetonide (FAc) implant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
0.19 mg fluocinolone acetonide (FAc) implant	Drug	0.19 mg fluocinolone acetonide (FAc) implant	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
BCVA	best corrected visual acuity	12 months

Secondary Outcomes

Measure	Description	Time Frame
CMT	Central Macular thickness	12 months
IOP	Intraocular pressure	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

DME
Pseudophakic

Exclusion Criteria:

Other causes of macular edema.
Phakic
Know case of gaucoma

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed Elbarky, MD	Contact	00971557443731	00971557443731	AHMED.ALBARQY@fmed.bu.edu.eg
Elbarky, MD	Contact	00971557443731	00971557443731	AHMED.ALBARQY@fmed.bu.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shiekh Khalifa medical city	Recruiting	Abu Dhabi		51900	United Arab Emirates

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

ID	Term
D005446	Fluocinolone Acetonide
C035000	CAF protocol
D004343	Drug Implants
D016254	Mutagenesis, Insertional

Ancestor Terms

ID	Term
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated
D003692	Delayed-Action Preparations
D004304	Dosage Forms
D004364	Pharmaceutical Preparations
D015202	Protein Engineering
D005818	Genetic Engineering
D005821	Genetic Techniques
D008919	Investigative Techniques
D009154	Mutation
D014644	Genetic Variation
D055614	Genetic Phenomena
D016296	Mutagenesis