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

Mid Atlantic Retina

Status: Unknown

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

Treatments: Procedure: Conj flora Antibiotic resistance

Study type: Interventional

Funder types: Other

Identifiers

NCT01531842

IRB#11-110

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Topical antibiotic

Experimental group

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).

Treatment:

Procedure: Conj flora Antibiotic resistance

No Antibiotic Arm

Other group

Description:

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

Treatment:

Procedure: Conj flora Antibiotic resistance