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

Not Applicable

• Conditions: Central Retinal Vein Occlusion; Choroidal Neovascularization; Age-related Macular Degeneration; Branch Retinal Vein Occlusion
• Interventions: Procedure: Conj flora Antibiotic resistance

• Registration Number: NCT01531842
• Lead Sponsor: Mid Atlantic Retina

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 Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-10-13
• Status Verified: 2012-02
• Study First Submitted QC: 2012-02-08
• Last Update Submitted: 2012-02-08
• Study First Posted: 2012-02-13
• Last Update Posted: 2012-02-13
• Primary Completion: 2013-02
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical antibiotic	Conj flora Antibiotic resistance	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).
No Antibiotic Arm	Conj flora Antibiotic resistance	No topical antibiotics in the -ABX arm (only the typical prep with betadine)

Primary Outcome Measures

Name	Time	Method
Determine if conj bacterial flora demonstrates increased antibiotic resistance if topical antibiotic used pre and post injection vs not used.	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.

Trial Locations

Locations (1)

Wills Eye Institute; 🇺🇸 Philadelphia, Pennsylvania, United States