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

Tracking Information

First Received Date ^ICMJE

October 13, 2011

Last Updated Date

February 8, 2012

Start Date ^ICMJE

August 2011

Estimated Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01531842 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Bacterial Resistance and Alterations in Conjunctival Flora Following Serial Intravitreal Injections

Brief Summary

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

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Condition ^ICMJE

Central Retinal Vein Occlusion
Choroidal Neovascularization
Age-related Macular Degeneration
Branch Retinal Vein Occlusion

Intervention ^ICMJE

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).

Study Arm (s)

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).

Intervention: Procedure: Conj flora Antibiotic resistance
No Antibiotic Arm
No topical antibiotics in the -ABX arm (only the typical prep with betadine)

Intervention: Procedure: Conj flora Antibiotic resistance

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2013

Estimated Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01531842

Other Study ID Numbers ^ICMJE

IRB#11-110

Has Data Monitoring Committee

Responsible Party

Michele Formoso, Mid Atlantic Retina

Study Sponsor ^ICMJE

Mid Atlantic Retina

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jason Hsu, MD

Mid Atlantic Retina

Information Provided By

Mid Atlantic Retina

Verification Date

February 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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