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OpenTrials
Completed

NCT Number: NCT06146309

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

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

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Key information

Conditions

Branch Retinal Vein Occlusion Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Retinal Diseases Retinal Vein Occlusion Thrombosis Vascular Diseases Venous Thrombosis

Age range

47 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akram Fekry Elgazzar

Damietta, 34517, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. peri-papillary retinal nerve fiber layer thickness

    Time frame: Base line

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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 24, 2023
Registry last updated
Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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