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

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

Detailed Description
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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.

Official Title
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Bacterial Resistance and Alterations in Conjunctival Flora Following Serial Intravitreal Injections

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

Intervention / Treatment
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* Procedure: Conj flora Antibiotic resistance


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topical antibiotic<br>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). | Procedure: Conj flora Antibiotic resistance<br>* Patients will either receive a drop of topical antibiotic before and after the intravitral injection or no topical antibiotics (only typical prep with betadine).<br>|
| Other: No Antibiotic Arm<br>No topical antibiotics in the -ABX arm (only the typical prep with betadine) | Procedure: Conj flora Antibiotic resistance<br>* Patients will either receive a drop of topical antibiotic before and after the intravitral injection or no topical antibiotics (only typical prep with betadine).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Conjunctival bacterial flora, prophylactic topical antibiotic, injection, intravitreal injection, bacterial resistance, serial injection, serial intravitreal injections, CNV, CRVO, AMD, BRVO