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Determining the Effect of Antibiotic Drop Prophylaxis on the Conjunctival Flora

NCT01577342 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2012-04-13

No results posted yet for this study

Summary

Ranibizumab (Lucentis) is currently the best treatment for wet Age-Related Macular Degeneration (AMD). To work, the drug must be injected by means of an intravitreal injection (IVT) into the vitreous (jelly-like material) cavity in the back of the eye, repeatedly at intervals ranging from one to several months. Endophthalmitis is a rare but devastating infection of the eye that occurs in approximately 0.2% of patients after IVT injection. Many ophthalmologists ask patients to use antibiotic eye drops after IVT injection in the hope that this may reduce the risk of endophthalmitis. There is no proof that this happens and there is a possible risk that repeated exposure to the same antibiotic may cause antibiotic resistance organisms (bacteria) to develop over time.

The investigators hypothesize that repeated exposure to antibiotic during the initial stages of treatment for AMD will result in a progressive shift in the conjunctival flora with an increasing number of antibiotic resistant organisms appearing over time. If this is demonstrated, changes to the prevailing treatment approach will be needed to reduce the long term risk of a patient developing antibiotic resistant endophthalmitis during treatment.

Conditions

  • Age-Related Macular Degeneration

Interventions

DRUG

Moxifloxacin 0.5%

1 drop 4 times daily times 3 days post ranibizumab intravitreal injection

Sponsors & Collaborators

  • St. Joseph's Healthcare Foundation

    collaborator OTHER

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • Philip L Hooper, MD, FRCSC · Ivey Eye Institute, St. Joseph's Health Care Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01577342 on ClinicalTrials.gov