Vitrectomy With Planned Foveal Detachment for Refractory... | NCT03345056

Studies
Vitrectomy With Planned Foveal Detachment for Refractory DME With or Without Vitreo-macular Interface Abnormality

NCT03345056

Sponsor

Ministry of Health and Population, Egypt

Status

Unknown status

Last Update Posted

Nov 17, 2017Actual

Enrollment

28Estimated

Phase

Not Applicable

Conditions

Chronic Edema of the Macula

Interventions

vitrectomy with planned foveal detachment

Countries

Not provided

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015Actual

Primary Completion Date

Nov 2017Estimated

Completion Date

Nov 2017Estimated

First Submitted Date

Nov 14, 2017

First Submission Date that Met QC Criteria

Nov 14, 2017

First Posted Date

Nov 17, 2017Actual

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

Nov 14, 2017

Last Update Posted Date

Nov 17, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

ahmed M. Abdel hadi, Assistant professor of ophthalmology, Ministry of Health and Population, EgyptPrincipal Investigator

Lead Sponsor

Ministry of Health and Population, EgyptOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate the therapeutic efficacy of sub retinal BSS injections in conjunction with conventional vitrectomy for refractory Diabetic macular edema (DME)- resistant to more than one anti-VEGF agent, intravitreal corticosteroids and to previous vitrectomy. Some of enrolled cases had normal vitreo-macular interface (VMI) relationship, while other cases had incomplete vitreoretinal separation with vitreomacular attachment (VMA).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
included cases	Other	vitrectomy done with planned foveal separation and followed for the result	Procedure: vitrectomy with planned foveal detachment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vitrectomy with planned foveal detachment	Procedure	23 gauge vitrectomy, posterior hyaloid detachment, internal limiting membrane peeling , sub-macular BSS injection using 38 gauge canula

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
central macular thickness decrease	decrease in central macular thickness by OCT	10 months postperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cases with refractory DME with a central macular thickness (CMT) of more than 300 µm despite undergoing anti-VEGF therapy (5-6 monthly injections of ranibizumab (IVR) or bevacizumab (IVB) with shifting to aflibercept (IVA) for additional 3 injections).

Exclusion Criteria:

The major exclusion criteria were: (1) presence of apparent retinal pigment epithelium (RPE) atrophy at or near the macula; (2) presence of proliferative diabetic fibrovascular membranes threating or at the macula; (3) presence of diabetic optic atrophy; and (4) presence of neovascular glaucoma.

Accepts Healthy Volunteers

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

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29854429	Derived	Abdel Hadi AM. Evaluation of Vitrectomy with Planned Foveal Detachment as Surgical Treatment for Refractory Diabetic Macular Edema with or without Vitreomacular Interface Abnormality. J Ophthalmol. 2018 May 7;2018:9246384. doi: 10.1155/2018/9246384. eCollection 2018.

ID	Term
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative