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

NCT06146309 | Completed

• 1 other identifier: Unilateral Branch Retinal Vein
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Branch Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (4)

• peri-papillary retinal nerve fiber layer thickness

  Layer of the retina. The thickness was measured by Optical Coherence Tomography

  Base line

• peri-papillary retinal nerve fiber layer thickness

  Layer of the retina. The thickness was measured by Optical Coherence Tomography

  6 months post injection

• peri-papillary retinal nerve fiber layer thickness

  Layer of the retina. The thickness was measured by Optical Coherence Tomography

  12 months post injection

• peri-papillary retinal nerve fiber layer thickness

  Layer of the retina. The thickness was measured by Optical Coherence Tomography

  24 months post injection

Study Arms (2)

Patients with unilateral BRVO

EXPERIMENTAL

Drug: aflibercept (2mg/0.05ml)

Healthy individuals

NO INTERVENTION

Interventions

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

Patients with unilateral BRVO

Eligibility Criteria

• Age: 47 Years - 68 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with unilateral BRVO

You may not qualify if:

• 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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Akram Fekry Elgazzar

Damietta, 34517, Egypt

Location

MeSH Terms

Conditions

Retinal Vein Occlusion

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 18, 2023
• First Posted: November 24, 2023
• Study Start: December 1, 2020
• Primary Completion: July 20, 2022
• Study Completion: August 1, 2022
• Last Updated: November 24, 2023

Record last verified: 2023-11

Locations

EG (1)