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Determining the Effect of Antibiotic Drop Prophylaxis on the Conjunctival Flora

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01577342
Recruitment Status : Completed
First Posted : April 13, 2012
Last Update Posted : April 13, 2012
St. Joseph's Healthcare Foundation
Information provided by (Responsible Party):
Phil Hooper, Lawson Health Research Institute

Brief 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.

Condition or disease Intervention/treatment
Age-Related Macular Degeneration Drug: Moxifloxacin 0.5%

Detailed Description:

Intraocular injection of a VEGF inhibitor on a repeated basis has become the standard of care for the treatment of Age-Related Macular Degeneration (AMD) following pivotal studies which demonstrated that vision could be stabilized in 90% of treated patients. Most patients require injection, on average, every two months indefinitely.

The incidence of intraocular infection (endophthalmitis) following intraocular injection is approximately 0.2%. Current injection protocols involve the use of topical poviodine prior to injection based on evidence that this significantly reduces the bacterial flora on the conjunctiva. Following injection there is often some reflux of vitreous fluid from the cavity of the eye into the subjunctival space. For this reason many Ophthalmologists have patients use topical antibiotics for 2-3 days post injection with the expectation that this may reduce the risk of infection as the eye is healing.

Ta et al have demonstrated that following a 3 day course of topical antibiotic the incidence of resistant strains of bacteria in the conjunctival sac does not significantly increase (159 patients).There are no longitudinal studies which examine the effects of repeated short term antibiotic exposure on the conjunctival flora over time.

This is a prospective, randomized, comparative study which will follow the conjunctival flora of patients undergoing induction treatment with a VEGF inhibitor for AMD. The incidence of resistant organisms in the group receiving antibiotics will be compared to that in a similar group who do not receive antibiotics. Following informed consent, patients will have a conjunctival swab taken by the treating Ophthalmologist after instillation of sterile topical anesthetic but before application of poviodine. The swabs will be cultured in thyoglycollate broth. Bacteria present and resistance to the antibiotic used will be identified. This process will be repeated each visit during the induction phase of treatment which consists of four sequential injections each a month apart.

Patients in the antibiotic arm will be asked to use topical Moxifloxacin drops 4 times a day for 3 days following injection. The control group will not receive antibiotics.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Determining the Effect of Antibiotic Drop Prophylaxis on the Conjunctival Flora
Study Start Date : November 2010
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Moxifloxacin 0.5%
1 drop four times daily for 3 days in affected eye post intravitreal injection
Drug: Moxifloxacin 0.5%
1 drop 4 times daily times 3 days post ranibizumab intravitreal injection
Other Name: Vigamox
No Intervention: No antibiotic use

Primary Outcome Measures :
  1. Incidence of antibiotic resistant organisms [ Time Frame: 4 months ]

    Conjunctival culture will be obtained in the designated "study" eye prior to the first intravitreal injection in de novo AMD patients and will be repeated prior to the next 3 injections.

    Susceptibility or resistance of the ocular surface flora to Moxifloxicin will be assessed by standard micro analysis.

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • all patients undergoing their first ever injection to treat AMD and who are expected to continue treatment in London for at least the next 3 injections are potentially eligible.
  • able to provide Informed Consent.

Exclusion Criteria:

  • current contact lens use.
  • use of topical antibiotics in the study eye in the preceding 6 months.
  • patients in whom eye surgery in the study eye is anticipated in the next 4 months.
  • documented allergy to the drug or vehicle.
  • patients with active ocular, periocular or systemic infection.
  • immunosuppressed patients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01577342

Canada, Ontario
Ivey Eye Institute, St. Joseph's Health Care Centre
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
St. Joseph's Healthcare Foundation
Principal Investigator: Philip L Hooper, MD, FRCSC Ivey Eye Institute, St. Joseph's Health Care Centre

Responsible Party: Phil Hooper, Principal Investigator, Lawson Health Research Institute Identifier: NCT01577342     History of Changes
Other Study ID Numbers: R-10-458
17354 ( Other Identifier: REB )
First Posted: April 13, 2012    Key Record Dates
Last Update Posted: April 13, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Antitubercular Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs