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

NCT03744806 | Completed

• 1 other identifier: KE-0254/208/2013
• Study Type: observational
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Exudative Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

treated with intravitreal bevacizumab.

Drug: Bevacizumab Injection

control group

Interventions

Bevacizumab Injection DRUG

treated with intravitreal bevacizumab.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Lublin: lead

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: November 16, 2018
• Study Start: January 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: August 1, 2018
• Last Updated: November 16, 2018

Record last verified: 2018-11