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

NCT01531842 | Unknown

• 1 other identifier: IRB#11-110
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Topical antibiotic

EXPERIMENTAL

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

No Antibiotic Arm

OTHER

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

Procedure: Conj flora Antibiotic resistance

Interventions

Conj flora Antibiotic resistance PROCEDURE

Patients will either receive a drop of topical antibiotic before and after the intravitral injection or no topical antibiotics (only typical prep with betadine).

No Antibiotic Arm; Topical antibiotic

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mid Atlantic Retina: lead

Study Sites (1)

Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Retinal Vein Occlusion; Choroidal Neovascularization; Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Retinal Degeneration

Study Officials

• Jason Hsu, MD

  Mid Atlantic Retina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Manager

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: February 13, 2012
• Study Start: August 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: August 1, 2013
• Last Updated: February 13, 2012

Record last verified: 2012-02

Locations

US (1)