Vitreous Level Of Tumor Necrosis Factor Alpha In Patients... | NCT05532475

Studies
Vitreous Level Of Tumor Necrosis Factor Alpha In Patients With Retinal Vein Occlusion

NCT05532475

Sponsor

Kasr El Aini Hospital

Status

Completed

Last Update Posted

Nov 27, 2024Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Retinal Vein Occlusion

Interventions

measurement of vitreous level of tumor necrosis factor alpha

Countries

Egypt

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 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 12, 2022Actual

Primary Completion Date

Oct 20, 2022Actual

Completion Date

Oct 30, 2022Actual

First Submitted Date

Sep 3, 2022

First Submission Date that Met QC Criteria

Sep 3, 2022

First Posted Date

Sep 8, 2022Actual

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 25, 2024

Last Update Posted Date

Nov 27, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohamed Ahmed Mohamed Attya, Lecturer of ophthalmology- faculty of medicine- Cairo University, Kasr El Aini HospitalPrincipal Investigator

Lead Sponsor

Kasr El Aini HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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 assess the levels of TNF- α in vitreous samples of patients with retinal vein occlusion prior to administration of intravitreal anti-VEGF and compare them to levels in vitreous samples of normal subjects so as to investigate the association of vitreous tumor necrosis factor with the pathogenesis of retinal vein occlusion.

Detailed Description

Not provided

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

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cases		patient with retinal vein occlusion	Diagnostic Test: measurement of vitreous level of tumor necrosis factor alpha
control		cataract patient undergoing cataract surgery	Diagnostic Test: measurement of vitreous level of tumor necrosis factor alpha

Interventions

Name	Type	Description	Arm Group Labels	Other Names
measurement of vitreous level of tumor necrosis factor alpha	Diagnostic Test	measurement of vitreous level of tumor necrosis factor alpha using ELISA technique	cases

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to assess vitreous level of tumor necrosis factor alpha in retinal vein occlusion and compare it to patient undergoing cataract surgery		Day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any patient with retinal vein occlusion not older than 6 months with no history of Anti-VEGF injection

Exclusion Criteria:

Diabetic patients.
Other causes of retinal vascular diseases.
Patients with history of treatment of retinal vein occlusion.
Previous intraocular surgery except cataract surgery performed 6 months before the study.
Subjects with severe systemic inflammatory diseases
Retinal vein occlusion secondary to retinal vasculitis.
All retinal pathologies.
Patients receiving Systemic steroids or Immunosuppressive therapy.

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

Retinal venous occlusion patients admitted in KasrAlainy Hospital for Intravitreal Injection of Lucentis (Cases) compared to patient without retinal vein occlusion admitted for cataract surgery (Controls).

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasr ALainy University hospital		Cairo		12916	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012170	Retinal Vein Occlusion

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D020246	Venous Thrombosis
D013927	Thrombosis

Browse Leaves

Not provided

Browse Branches

Not provided