Assessment Of Peri-papillary Retinal Nerve Fiber Layer Thickness In Patients With Unilateral Branch Retinal Vein Occlusion

Branch Retinal Vein Occlusion Clinical Trial

Official title:

Assessment Of Peri-papillary Retinal Nerve Fiber Layer Thickness In Patients With Unilateral Branch Retinal Vein Occlusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06146309
• Other study ID #: Unilateral Branch Retinal Vein
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: August 1, 2022

Study information

• Verified date: November 2023
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 there may be systemic risk factors for both RVO and glaucoma

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 1, 2022
• Est. primary completion date: July 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 47 Years to 68 Years

Eligibility

Inclusion Criteria:

• patients with unilateral BRVO

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Branch Retinal Vein Occlusion
• Retinal Vein Occlusion

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Egypt	Akram Fekry Elgazzar	Damietta

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	peri-papillary retinal nerve fiber layer thickness	Layer of the retina. The thickness was measured by Optical Coherence Tomography	Base line
Primary	peri-papillary retinal nerve fiber layer thickness	Layer of the retina. The thickness was measured by Optical Coherence Tomography	6 months post injection
Primary	peri-papillary retinal nerve fiber layer thickness	Layer of the retina. The thickness was measured by Optical Coherence Tomography	12 months post injection
Primary	peri-papillary retinal nerve fiber layer thickness	Layer of the retina. The thickness was measured by Optical Coherence Tomography	24 months post injection