Branch Retinal Vein OcclusionNCT06146309
Assessment Of Peri-papillary Retinal Nerve Fiber Layer Thickness In Patients With Unilateral Branch Retinal Vein Occlusion
A study testing aflibercept (2mg/0.05ml) in people with Branch Retinal Vein Occlusion, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Several studies have indicated a relation between the development of RVO and elevated intraocular pressure (IOP) and glaucoma [9]. Further investigations into the structural alterations in the fellow eyes of individuals with unilateral RVO have revealed that the pRNFL is thinner than in healthy eyes, suggesting that… Read more about this study
- Who is it for?
- Ages 47 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Branch Retinal Vein Occlusion
- What is being tested?
- aflibercept (2mg/0.05ml)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 1 Aug 2022
- Phase
- Interventional
- 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 47 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with unilateral BRVO
Who cannot join
- History of retinal and/or optic nerve diseases involving glaucomatous optic disc, ischemic optic neuropathy, or optic neuritis.
- History of trauma, intravitreal injections, vitreoretinal surgeries, and retinal or macular lasers.
- A significant media opacity that makes it difficult to capture clear images.
- No history of diabetes and/or hypertension in those recruited as the control group
Trial locations and contacts
1 site in 1 country.
About this study
Several studies have indicated a relation between the development of RVO and elevated intraocular pressure (IOP) and glaucoma [9]. Further investigations into the structural alterations in the fellow eyes of individuals with unilateral RVO have revealed that the pRNFL is thinner than in healthy eyes, suggesting that there may be systemic risk factors for both RVO and glaucoma
- Conditions
- Branch Retinal Vein Occlusion
- Being tested
- aflibercept (2mg/0.05ml)
- 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.
aflibercept (2mg/0.05ml)Drug
Aflibercept is a medication used to treat and manage neovascular age-related macular degeneration, diabetic macular edema, myopic choroidal neovascularization, macular edema associated with retinal vein occlusion, and diabetic retinopathy. It is in the vascular endothelial growth factor-A (VEGF-A) and placental growth factor (PlGF) antagonist class of medications. Aflibercept acts as a soluble protein decoy for VEGF receptors to inhibit the predominant signaling pathway responsible for angiogenesis and vascular leakage. Aflibercept and other anti-VEGF inhibitors have become the gold standard in controlling neovascular (wet) age-related macular degeneration (NVAMD). T
| Study group | Role | What they receive |
|---|---|---|
| Patients with unilateral BRVO | Experimental | Not described Receives: Drug: aflibercept (2mg/0.05ml) |
| Healthy individuals | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
peri-papillary retinal nerve fiber layer thickness
Layer of the retina. The thickness was measured by Optical Coherence Tomography
Measured: Base line
peri-papillary retinal nerve fiber layer thickness
Layer of the retina. The thickness was measured by Optical Coherence Tomography
Measured: 6 months post injection
peri-papillary retinal nerve fiber layer thickness
Layer of the retina. The thickness was measured by Optical Coherence Tomography
Measured: 12 months post injection
peri-papillary retinal nerve fiber layer thickness
Layer of the retina. The thickness was measured by Optical Coherence Tomography
Measured: 24 months post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start1 Dec 2020
- Primary completion20 Jul 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Branch Retinal Vein OcclusionStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akram Fekry Elgazzar, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146309
- Sponsor's protocol ID
- Unilateral Branch Retinal Vein
- Status last verified
- Nov 2023
- First submitted
- 18 Nov 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Of Peri-papillary Retinal Nerve Fiber Layer Thickness In Patients With Unilateral Branch Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT06146309
- Acronym / sponsor ID
- Unilateral Branch Retinal Vein
- Conditions
- Branch Retinal Vein Occlusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 24 Nov 2023 (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.
Several studies have indicated a relation between the development of RVO and elevated intraocular pressure (IOP) and glaucoma [9]. Further investigations into the structural alterations in the fellow eyes of individuals with unilateral RVO have revealed that the pRNFL is thinner than in healthy eyes, suggesting that there may be systemic risk factors for both RVO and glaucoma
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with unilateral BRVO | Experimental | Drug: aflibercept (2mg/0.05ml) |
| Healthy individuals | No intervention | – |
Who may qualify
- Ages
- 47 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with unilateral BRVO
Key exclusion criteria (4 listed)
- History of retinal and/or optic nerve diseases involving glaucomatous optic disc, ischemic optic neuropathy, or optic neuritis.
- History of trauma, intravitreal injections, vitreoretinal surgeries, and retinal or macular lasers.
- A significant media opacity that makes it difficult to capture clear images.
- No history of diabetes and/or hypertension in those recruited as the control group
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 |
|---|---|---|
| aflibercept (2mg/0.05ml)Aflibercept is a medication used to treat and manage neovascular age-related macular degeneration, diabetic macular edema, myopic choroidal neovascularization, macular edema associated with retinal vein occlusion, and diabetic retinopathy. It is in the vascular endothelial growth factor-A (VEGF-A) and placental growth factor (PlGF) antagonist class of medications. Aflibercept acts as a soluble protein decoy for VEGF receptors to inhibit the predominant signaling pathway responsible for angiogenesis and vascular leakage. Aflibercept and other anti-VEGF inhibitors have become the gold standard in controlling neovascular (wet) age-related macular degeneration (NVAMD). T | Drug | Patients with unilateral BRVO |
Primary outcome
peri-papillary retinal nerve fiber layer thickness
Time frame: Base line
Layer of the retina. The thickness was measured by Optical Coherence Tomography
peri-papillary retinal nerve fiber layer thickness
Time frame: 6 months post injection
Layer of the retina. The thickness was measured by Optical Coherence Tomography
peri-papillary retinal nerve fiber layer thickness
Time frame: 12 months post injection
Layer of the retina. The thickness was measured by Optical Coherence Tomography
peri-papillary retinal nerve fiber layer thickness
Time frame: 24 months post injection
Layer of the retina. The thickness was measured by Optical Coherence Tomography
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 24 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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?
A study testing aflibercept (2mg/0.05ml) in people with Branch Retinal Vein Occlusion, run by Al-Azhar University 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 4 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 24 Nov 2023. 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?
peri-papillary retinal nerve fiber layer thickness (time frame: Base line). The study lists 4 primary outcomes in all. 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 24 Nov 2023.