Determining the Effect of Antibiotic Drop Prophylaxis on the Conjunctival Flora

NCT01577342 | Completed

• 2 other identifiers: R-10-45817354
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Incidence of antibiotic resistant organisms

  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.

  4 months

Study Arms (2)

Moxifloxacin 0.5%

ACTIVE COMPARATOR

1 drop four times daily for 3 days in affected eye post intravitreal injection

Drug: Moxifloxacin 0.5%

No antibiotic use

NO INTERVENTION

Interventions

Moxifloxacin 0.5% DRUG

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

Also known as: Vigamox

Moxifloxacin 0.5%

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• St. Joseph's Healthcare Foundation: collaborator

Study Sites (1)

Ivey Eye Institute, St. Joseph's Health Care Centre

London, Ontario, N6A 4V2, Canada

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Philip L Hooper, MD, FRCSC

  Ivey Eye Institute, St. Joseph's Health Care Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2012
• First Posted: April 13, 2012
• Study Start: November 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 13, 2012

Record last verified: 2012-04

Locations

CA (1)