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

This study is currently recruiting participants.
Verified February 2012 by Mid Atlantic Retina
Sponsor:
Information provided by (Responsible Party):
Michele Formoso, Mid Atlantic Retina
ClinicalTrials.gov Identifier:
NCT01531842
First received: October 13, 2011
Last updated: February 8, 2012
Last verified: February 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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. ] [ Designated as safety issue: No ]
    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.

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531842

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

No publications provided

Responsible Party: Michele Formoso, Research Manager, Mid Atlantic Retina
ClinicalTrials.gov Identifier: NCT01531842     History of Changes
Other Study ID Numbers: IRB#11-110
Study First Received: October 13, 2011
Last Updated: February 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 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:
Macular Degeneration
Neovascularization, Pathologic
Retinal Vein Occlusion
Choroidal Neovascularization
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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013