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NCT03744806 Clinical Trial

Blood-aqueous Barrier Integrity in Eyes Undergoing Intravitreal Bevacizumab Therapy to Treat Neovascular AMD

Exudative Age-related Macular Degeneration Clinical Trial

Official title:
Blood-aqueous Barrier Integrity in Eyes Undergoing Intravitreal Bevacizumab Therapy to Treat Neovascular Age-related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03744806
Other study ID # KE-0254/208/2013
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2015
Est. completion date August 2018

Study information
Verified date November 2018
Source Medical University of Lublin
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to evaluate the effect of repeated intravitreal bevacizumab injections on blood-aqueous barrier permeability in eyes with neovascular age-related macular degeneration (AMD).

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date August 2018
Est. primary completion date September 2015
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- active AMD-associated choroidal neovascularization (CNV) confirmed with fluorescein angiography (FA) and optical coherence tomography (OCT)

Exclusion Criteria:

- history of uveitis, vitreous hemorrhage, neovascular glaucoma, corneal opacities, recent ocular surgery (within 3 months), or prior anti- vascular endothelial growth factor (VEGF) injections

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bevacizumab Injection

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Lublin

Outcome
Type Measure Description Time frame Safety issue
Primary Anterior chamber (AC) inflammation evaluated with laser flare photometry. All patients were examined before and 1 day and 1 month after each intravitreal bevacizumab injection. Subjects were followed for a period of 4 months in both the study and control groups. The final flare photometry value was automatically calculated by averaging 5 individual measurements. A total of 7 measurements were obtained, but the highest and lowest measurement values were excluded by the flare meter. All statistical analyses were performed using STATISTICA 12 statistical software. 4 months
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