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A Research Study to Evaluate the Effects of Repeated Intravitreal Injections on Bacteria Around the Eye

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ClinicalTrials.gov Identifier: NCT01531842
Recruitment Status : Unknown
Verified February 2012 by Michele Formoso, Mid Atlantic Retina.
Recruitment status was:  Recruiting
First Posted : February 13, 2012
Last Update Posted : February 13, 2012
Sponsor:
Information provided by (Responsible Party):
Michele Formoso, Mid Atlantic Retina

Study Description
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Brief Summary:
This is a research study to evaluate the effects of repeated intravitreal injections on bacteria around the eye.

Condition or disease Intervention/treatment Phase
Central Retinal Vein Occlusion Choroidal Neovascularization Age-related Macular Degeneration Branch Retinal Vein Occlusion Procedure: Conj flora Antibiotic resistance Not Applicable

Detailed Description:
The primary objective of this study is to determine whether conjunctival bacterial flora are altered and/or demonstrate increasing antibiotic resistance after serial intravitreal injections when a prophylactic topical antibiotic is used pre- and post-injection compared to when they are not used.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Bacterial Resistance and Alterations in Conjunctival Flora Following Serial Intravitreal Injections
Study Start Date : August 2011
Estimated Primary Completion Date : February 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arms and Interventions
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Arm Intervention/treatment
Experimental: Topical antibiotic
Patients will be randomized in a 1:1 fashion to receive a drop of topical antibiotic before and after the intravitreal injection in the +ABX arm (in addition to the typical prep with betadine).
 Procedure: Conj flora Antibiotic resistance
Patients will either receive a drop of topical antibiotic before and after the intravitral injection or no topical antibiotics (only typical prep with betadine).
No Antibiotic Arm
No topical antibiotics in the -ABX arm (only the typical prep with betadine)
 Procedure: Conj flora Antibiotic resistance
Patients will either receive a drop of topical antibiotic before and after the intravitral injection or no topical antibiotics (only typical prep with betadine).


Outcome Measures
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Primary Outcome Measures :
  1. Determine if conj bacterial flora demonstrates increased antibiotic resistance if topical antibiotic used pre and post injection vs not used. [ Time Frame: Prior to each of your eye injections for the first 4 injections and continue through the completion of your fourth injection, an anticipated maximum of 6 months. ]
    Evaluating the effects of repeated use of iodine drops with or without antibiotic eye drops on bacteria on the eye surface in patients undergoing injections in the eye to determine if conjunctival bacterial floar are altered or demonstate increasing antibiotic resistance.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Subjects will be eligible if the following criteria are met:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study.
  • Have been diagnosed with neovascular AMD, CRVO or BRVO.
  • Have been determined by the investigator to require intravitreal injections of bevacizumab or ranibizumab.

Exclusion Criteria: Subjects meeting any of the following criteria are ineligible for study entry:

  • Prior intraocular injection in either eye.
  • Chronic use of opthalmic medication.
  • Contact lens wear.
  • Ocular surgery within the past 6 months.
  • Use of ophthalmic medications in either eye or ocular infection within the past 6 months.
  • Use of systemic antibiotics within 6 months.
  • Known allergy or contraindication to povidone iodine or fluoroquinolones.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531842


Locations
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United States, Pennsylvania
Wills Eye Institute Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Michele Formoso    215-928-3092      
Contact: Jason Hsu, MD    215-928-3300      
Principal Investigator: Jason Hsu, M.D.         
Sponsors and Collaborators
Mid Atlantic Retina
Investigators
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Principal Investigator: Jason Hsu, MD Mid Atlantic Retina
More Information
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Responsible Party: Michele Formoso, Research Manager, Mid Atlantic Retina
ClinicalTrials.gov Identifier: NCT01531842    
Other Study ID Numbers: IRB#11-110
First Posted: February 13, 2012    Key Record Dates
Last Update Posted: February 13, 2012
Last Verified: February 2012
Keywords provided by Michele Formoso, Mid Atlantic Retina:
Conjunctival bacterial flora
prophylactic topical antibiotic
injection
intravitreal injection
bacterial resistance
serial injection
 serial intravitreal injections
CNV
CRVO
AMD
BRVO
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Vein Occlusion
Choroidal Neovascularization
Neovascularization, Pathologic
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
 Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Choroid Diseases
Uveal Diseases
Anti-Bacterial Agents
Anti-Infective Agents