NCT05532475

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 8, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

7 months

First QC Date

September 3, 2022

Last Update Submit

November 25, 2024

Conditions

Keywords

Tumor necrosis factor alpha

Outcome Measures

Primary Outcomes (1)

  • to assess vitreous level of tumor necrosis factor alpha in retinal vein occlusion and compare it to patient undergoing cataract surgery

    Day 1

Study Arms (2)

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

measurement of vitreous level of tumor necrosis factor alpha using ELISA technique

casescontrol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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).

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr ALainy University hospital

Cairo, 12916, Egypt

Location

MeSH Terms

Conditions

Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of ophthalmology- faculty of medicine- Cairo University

Study Record Dates

First Submitted

September 3, 2022

First Posted

September 8, 2022

Study Start

March 12, 2022

Primary Completion

October 20, 2022

Study Completion

October 30, 2022

Last Updated

November 27, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations