Clinical trial

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

Name

Unilateral Branch Retinal Vein

Description

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

Trial arms

Trial start

2020-12-01

Estimated PCD

2022-07-20

Trial end

2022-08-01

Status

Completed

Treatment

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

Arms:

Patients with unilateral BRVO

Size

Primary endpoint

peri-papillary retinal nerve fiber layer thickness

Base line

peri-papillary retinal nerve fiber layer thickness

6 months post injection

peri-papillary retinal nerve fiber layer thickness

12 months post injection

peri-papillary retinal nerve fiber layer thickness

24 months post injection

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

Updated at

2023-11-24

1 organization

1 product

1 indication

Organization

Al-Azhar University

Product

Aflibercept

Indication

Retinal Vein Occlusion