Retinal Vein OcclusionNCT05532475
Vitreous Level Of Tumor Necrosis Factor Alpha In Patients With Retinal Vein Occlusion
An observational study of Retinal Vein Occlusion, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Vein Occlusion
- What is being tested?
- measurement of vitreous level of tumor necrosis factor alpha
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Mar 2022to 30 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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).
Who may be able to join
- Any patient with retinal vein occlusion not older than 6 months with no history of Anti-VEGF injection
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Retinal Vein Occlusion
- Being tested
- measurement of vitreous level of tumor necrosis factor alpha
- Keywords
- Tumor necrosis factor alpha
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of vitreous level of tumor necrosis factor alphaDiagnostic test
measurement of vitreous level of tumor necrosis factor alpha using ELISA technique
| Study group | Role | What they receive |
|---|---|---|
| cases | patient with retinal vein occlusion Receives: Diagnostic Test: measurement of vitreous level of tumor necrosis factor alpha | |
| control | cataract patient undergoing cataract surgery Receives: Diagnostic Test: measurement of vitreous level of tumor necrosis factor alpha |
What is being measured
The primary outcome is the main question the study is designed to answer.
to assess vitreous level of tumor necrosis factor alpha in retinal vein occlusion and compare it to patient undergoing cataract surgery
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start12 Mar 2022
- Primary completion20 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Vein OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Mohamed Attya, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532475
- Sponsor's protocol ID
- MS-654-2021
- Status last verified
- Nov 2024
- First submitted
- 3 Sep 2022
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitreous Level Of Tumor Necrosis Factor Alpha In Patients With Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT05532475
- Acronym / sponsor ID
- MS-654-2021
- Conditions
- Retinal Vein Occlusion
- Keywords
- Tumor necrosis factor alpha
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 12 Mar 2022 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | – | Diagnostic Test: measurement of vitreous level of tumor necrosis factor alphapatient with retinal vein occlusion |
| control | – | Diagnostic Test: measurement of vitreous level of tumor necrosis factor alphacataract patient undergoing cataract surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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).
Key inclusion criteria (1 listed)
- Any patient with retinal vein occlusion not older than 6 months with no history of Anti-VEGF injection
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measurement of vitreous level of tumor necrosis factor alphameasurement of vitreous level of tumor necrosis factor alpha using ELISA technique | Diagnostic test | cases, control |
Primary outcome
to assess vitreous level of tumor necrosis factor alpha in retinal vein occlusion and compare it to patient undergoing cataract surgery
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Retinal Vein Occlusion
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy
RecruitingObservational study
National Eye Institute Biorepository for Retinal Diseases
Age-Related Macular Degeneration, Diabetic Retinopathy
Not yet recruitingPhase 4
Iopidine to Decrease Intraocular Pressure Rise After Injections
Macular Degeneration, Diabetic Retinopathy
Recruiting
Robotic RVO Trial: Robot-assisted Retinal Vein Cannulation in Patients With Retinal Vein Occlusions
Retinal Vein Occlusion (RVO)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Vein Occlusion, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to assess vitreous level of tumor necrosis factor alpha in retinal vein occlusion and compare it to patient undergoing cataract surgery (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.