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Resistance to Antibiotics in Patients Receiving Eye Injections

Prospective Study on Antimicrobial Resistance Rates Following Repeated Courses of Topical Antibiotics for Intravitreal Injection

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02126423
Enrollment
40
Registered
2014-04-30
Start date
2014-05-31
Completion date
2014-09-30
Last updated
2016-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-Related Macular Degeneration, Diabetic Retinopathy, Retinal Vein Occlusion

Keywords

Drug Resistance, Microbial

Brief summary

The administration of short courses of topical antibiotic drops before and/or after intravitreal injections is a common practice, but increasing evidence suggests this may not lower the risk of infectious endophthalmitis and could increase rates of antimicrobial resistance. The purpose of the present study is to determine the antimicrobial resistance profiles in patients who have received numerous (≥ 20) courses of antibiotics for intravitreal injection compared with untreated controls. This study compares 20 control patients without prior intravitreal injection to 20 patients who have undergone ≥ 20 prior intravitreal injections accompanied by a course of topical antibiotics for two days before and/or after the injection procedure. The lower, inner eyelid and nasal cavity were cultured and evaluated via disk diffusion method for antimicrobial sensitivity.

Detailed description

Before administration of anti-VEGF therapy (Vascular Endothelial Growth Factor) or topical antibiotics, conjunctival and nasopharyngeal swabs are procured with the Bacti-Swab transport system (Thermo Fisher Scientific, Waltham, MA). For conjunctival samples, a sterile swab is moistened with ophthalmic balanced salt solution and gently swept along the lower fornix from the medial to the lateral canthi, with all attempts to avoid the eyelashes and eyelids. For nasopharyngeal cultures, the sterile swab is inserted 2 cm into the naris and rotated against the anterior nasal mucosa for 3 seconds. Culture swabs are then plated onto 5% sheep blood plates and incubated at 37°C for 3 days. Colonies are isolated and identified with API (Analytical Profile Index) Microbial Identification Kits (bioMérieux Inc., Hazelwood, MO). Antibiotic susceptibility is determined using the Kirby Bauer disc diffusion method. Additional data collected includes age, ocular and systemic medical conditions, and the number of intravitreal injections along with anti-VEGF agents used. Statistical calculations for antibiotic resistance comprises of t-test and and multivariate analysis.

Interventions

OTHERConjunctival and nasopharyngeal swabs

For conjunctival samples, a sterile swab is moistened with ophthalmic balanced salt solution and gently swept along the lower fornix from the medial to the lateral canthi, with all attempts to avoid the eyelashes and eyelids. For nasopharyngeal cultures, the sterile swab is inserted 2 cm into the naris and rotated against the anterior nasal mucosa for 3 seconds.

Sponsors

Genentech, Inc.
CollaboratorINDUSTRY
Prism Vision Group
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients (above age 18) diagnosed with age-related macular degeneration and receiving their 1st or 20th (or \>20th) intravitreal injection therapy.

Exclusion criteria

* Those with current use of topical or systemic antibiotics and an active ocular infection or ocular surface disease.

Design outcomes

Primary

MeasureTime frameDescription
Kirby Bauer disc diffusion antimicrobial susceptibility15 minutesOne set of conjunctival and nasopharyngeal swabs obtained from patient shortly after recruitment. Antibiotic susceptibility is determined using the Kirby Bauer disc diffusion method for the following antibiotics: amoxicillin/clavulanate, cefazolin, cefoxitin, erythromycin, moxifloxacin, trimethoprim/sulfamethoxazole, linezolid, clindamycin, and doxycycline.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026