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

February 8, 2012 updated by: Michele Formoso, Mid Atlantic Retina

Bacterial Resistance and Alterations in Conjunctival Flora Following Serial Intravitreal Injections

This is a research study to evaluate the effects of repeated intravitreal injections on bacteria around the eye.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Wills Eye Institute
        • Contact:
          • Michele Formoso
          • Phone Number: 215-928-3092
        • Contact:
          • Jason Hsu, MD
          • Phone Number: 215-928-3300
        • Principal Investigator:
          • Jason Hsu, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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).
Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mid Atlantic Retina

Investigators

  • Principal Investigator: Jason Hsu, MD, Mid Atlantic Retina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Anticipated)

February 1, 2013

Study Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

October 13, 2011

First Submitted That Met QC Criteria

February 8, 2012

First Posted (Estimate)

February 13, 2012

Study Record Updates

Last Update Posted (Estimate)

February 13, 2012

Last Update Submitted That Met QC Criteria

February 8, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB#11-110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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