search
Back to results

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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Conj flora Antibiotic resistance
Sponsored by
Mid Atlantic Retina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Central Retinal Vein Occlusion focused on measuring Conjunctival bacterial flora, prophylactic topical antibiotic, injection, intravitreal injection, bacterial resistance, serial injection, serial intravitreal injections, CNV, CRVO, AMD, BRVO

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wills Eye InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Topical antibiotic

No Antibiotic Arm

Arm Description

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 topical antibiotics in the -ABX arm (only the typical prep with betadine)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 13, 2011
Last Updated
February 8, 2012
Sponsor
Mid Atlantic Retina
search

1. Study Identification

Unique Protocol Identification Number
NCT01531842
Brief Title
A Research Study to Evaluate the Effects of Repeated Intravitreal Injections on Bacteria Around the Eye
Official Title
Bacterial Resistance and Alterations in Conjunctival Flora Following Serial Intravitreal Injections
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
February 2013 (Anticipated)
Study Completion Date
August 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mid Atlantic Retina

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Retinal Vein Occlusion, Choroidal Neovascularization, Age-related Macular Degeneration, Branch Retinal Vein Occlusion
Keywords
Conjunctival bacterial flora, prophylactic topical antibiotic, injection, intravitreal injection, bacterial resistance, serial injection, serial intravitreal injections, CNV, CRVO, AMD, BRVO

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Topical antibiotic
Arm Type
Experimental
Arm Description
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).
Arm Title
No Antibiotic Arm
Arm Type
Other
Arm Description
No topical antibiotics in the -ABX arm (only the typical prep with betadine)
Intervention Type
Procedure
Intervention Name(s)
Conj flora Antibiotic resistance
Intervention Description
Patients will either receive a drop of topical antibiotic before and after the intravitral injection or no topical antibiotics (only typical prep with betadine).
Primary Outcome Measure Information:
Title
Determine if conj bacterial flora demonstrates increased antibiotic resistance if topical antibiotic used pre and post injection vs not used.
Description
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.
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.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Hsu, MD
Organizational Affiliation
Mid Atlantic Retina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wills Eye Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Formoso
Phone
215-928-3092
First Name & Middle Initial & Last Name & Degree
Jason Hsu, MD
Phone
215-928-3300
First Name & Middle Initial & Last Name & Degree
Jason Hsu, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs