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

Sponsor

Al-Azhar University (Other)

Overall Status

Completed

CT.gov ID

NCT06146309

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Branch Retinal Vein Occlusion	Drug: aflibercept (2mg/0.05ml)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2020

Actual Primary Completion Date :

Jul 20, 2022

Actual Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients with unilateral BRVO	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
No Intervention: Healthy individuals

Arm

Intervention/Treatment

Experimental: Patients with unilateral BRVO

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

No Intervention: Healthy individuals

Outcome Measures

Primary Outcome Measures

peri-papillary retinal nerve fiber layer thickness [Base line]
Layer of the retina. The thickness was measured by Optical Coherence Tomography
peri-papillary retinal nerve fiber layer thickness [6 months post injection]
Layer of the retina. The thickness was measured by Optical Coherence Tomography
peri-papillary retinal nerve fiber layer thickness [12 months post injection]
Layer of the retina. The thickness was measured by Optical Coherence Tomography
peri-papillary retinal nerve fiber layer thickness [24 months post injection]
Layer of the retina. The thickness was measured by Optical Coherence Tomography

Eligibility Criteria

Criteria

Ages Eligible for Study:

47 Years to 68 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Akram Fekry Elgazzar	Damietta		Egypt	34517

Sponsors and Collaborators

Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Akram Fekry Elgazzar, Principal Investigator, Al-Azhar University

ClinicalTrials.gov Identifier:

NCT06146309

Other Study ID Numbers:

Unilateral Branch Retinal Vein

First Posted:

Nov 24, 2023

Last Update Posted:

Nov 24, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Retinal Vein Occlusion

Aflibercept

Study Results

No Results Posted as of Nov 24, 2023