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

Age-related Macular Degeneration Clinical Trial

Official title:

Bacterial Resistance and Alterations in Conjunctival Flora Following Serial Intravitreal Injections

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01531842
• Other study ID #: IRB#11-110
• Status: Unknown status
• Phase: N/A
• First received: October 13, 2011
• Last updated: February 8, 2012
• Start date: August 2011
• Est. completion date: August 2013

Study information

• Verified date: February 2012
• Source: Mid Atlantic Retina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 30
• Est. completion date: August 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• 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).

Locations

Country	Name	City	State
United States	Wills Eye Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Mid Atlantic Retina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.