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

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ClinicalTrials.gov Identifier: NCT03744806
Recruitment Status : Completed
First Posted : November 16, 2018
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of Lublin

Study Description
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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).

Condition or disease Intervention/treatment
Exudative Age-related Macular Degeneration Drug: Bevacizumab Injection

Study Design
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Study Type : Observational
Actual Enrollment : 48 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Blood-aqueous Barrier Integrity in Eyes Undergoing Intravitreal Bevacizumab Therapy to Treat Neovascular Age-related Macular Degeneration
Actual Study Start Date : January 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Groups and Cohorts
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Group/Cohort Intervention/treatment
treated with intravitreal bevacizumab. Drug: Bevacizumab Injection
control group


Outcome Measures
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Primary Outcome Measures :
  1. Anterior chamber (AC) inflammation evaluated with laser flare photometry. [ Time Frame: 4 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic
Criteria

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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Medical University of Lublin
ClinicalTrials.gov Identifier: NCT03744806    
Other Study ID Numbers: KE-0254/208/2013
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors