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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by Mid Atlantic Retina.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Michele Formoso, Mid Atlantic Retina Identifier:
First received: October 13, 2011
Last updated: February 8, 2012
Last verified: February 2012
This is a research study to evaluate the effects of repeated intravitreal injections on bacteria around the eye.

Condition Intervention
Central Retinal Vein Occlusion
Choroidal Neovascularization
Age-related Macular Degeneration
Branch Retinal Vein Occlusion
Procedure: Conj flora Antibiotic resistance

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Bacterial Resistance and Alterations in Conjunctival Flora Following Serial Intravitreal Injections

Resource links provided by NLM:

Further study details as provided by Mid Atlantic Retina:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 30
Study Start Date: August 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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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Please refer to this study by its identifier: NCT01531842

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
Principal Investigator: Jason Hsu, MD Mid Atlantic Retina
  More Information

Responsible Party: Michele Formoso, Research Manager, Mid Atlantic Retina Identifier: NCT01531842     History of Changes
Other Study ID Numbers: IRB#11-110
Study First Received: October 13, 2011
Last Updated: February 8, 2012

Keywords provided by Mid Atlantic Retina:
Conjunctival bacterial flora
prophylactic topical antibiotic
intravitreal injection
bacterial resistance
serial injection
serial intravitreal injections

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Retinal Vein Occlusion
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathologic Processes
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Choroid Diseases
Uveal Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents processed this record on May 23, 2017