Recruiting

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

Sponsor:

Mid Atlantic Retina

Code:

NCT01531842

Conditions

Central Retinal Vein Occlusion

Choroidal Neovascularization

Age-related Macular Degeneration

Branch Retinal Vein Occlusion

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Conj flora Antibiotic resistance

Study Details

Brief summary:

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

Conditions

Central Retinal Vein Occlusion

Choroidal Neovascularization

Age-related Macular Degeneration

Branch Retinal Vein Occlusion

Study ID

NCT01531842

Start date

Aug, 2011

Status verified date

Feb, 2012

Completion date

Aug, 2013

Anticipated

Primary completion date

Feb, 2013

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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).

other: No Antibiotic Arm

No topical antibiotics in the -ABX arm (only the typical prep with betadine)

Interventions

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).

Primary outcome measure

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. ]

Central Contacts and Locations

Locations

Wills Eye Institute

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Michele Formoso

215-928-3092

Jason Hsu, MD

215-928-3300

Principal Investigator:

Jason Hsu, M.D.

More Information

Sponsor

Mid Atlantic Retina

Last update posted

Feb 13, 2012

Last verified

Feb, 2012

Keywords

Conjunctival bacterial flora
prophylactic topical antibiotic
injection
intravitreal injection
bacterial resistance
serial injection
serial intravitreal injections
CNV
CRVO
AMD
BRVO

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mid Atlantic Retina on 2012-02-13.