Endophthalmitis After Intravitreous Anti-VEGF Injections in Patients Receiving vs. Not Receiving Topical Antibiotics

June 20, 2016 updated by: Voraporn Chaikitmongkol, Chiang Mai University

Incidence of Endophthalmitis After Intravitreous Anti-vascular Endothelial Growth Factor Injections Comparison Between Patients Receiving Versus Not Receiving Topical Antibiotics Following the Injections

This is a prospective case series which aims to determine the incidence of endophthalmitis following intravitreous anti-vascular endothelial growth factor (VEGF) injection comparing between eyes receiving post-injection antibiotics drops and those not receiving antibiotics drops treated at Chiang Mai University Hospital between May 2015 and April 2017 (2-year period).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Intravitreous anti-VEGF injection has been the most common procedure performed at eye clinics worldwide. It becomes the gold standard treatment for many macular diseases, such as diabetic macular edema and neovascular age-related macular degeneration (AMD). One of the most serious complication after intravitreous injection is post-injection endophthalmitis. There is no proven preventive strategy of post-injection endophthalmitis except the use of povidone iodine. However, a number of physicians around the world prescribe topical antibiotics after the injection, despite the lack of evidence to support the benefit of topical antibiotics to prevent the occurence of endophthalmitis. Recently, many large trials from the US including the Diabetic Retinopathy Clinical Research Network (DRCR.net), the Comparison of AMD Treatment Trials (CATT) study have reported the incidence of post-injection endophthalmitis comparing between eyes receiving versus not receiving post-injection antibiotics, and the results of all studies suggested that topical antibiotics does not help reduce the incidence of post-injection endophthalmitis. In addition, the results suggested that eyes receiving antibiotics had higher rate of endophthalmitis comparing to those not receiving antibiotics. Therefore, a majority of physicians in the United States have stopped prescribing antibiotics drops following the injection. However, a majority of physicians in Asia-Pacific region still prescribe antibiotics drops following the injection (according to the Preferences and Trends (PAT) survey by the American Society of Retina Specialists in 2014).

Due to the limited evidence from Asian literature whether there is difference between incidence of endophthalmitis following intravitreous anti-VEGF injection between eyes receiving antibiotics drops versus not receiving antibiotics drops in the Asian setting, the investigators conducted this study to determine the incidence of endophthalmitis after intravitreous anti-VEGF injection, comparing between eyes receiving post-injection antibiotics versus not receiving. Results from this study would be beneficial to guide an appropriate practice for physicians in the Asian region.

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Chiang Mai
      • Muang Chiang Mai, Chiang Mai, Thailand, 50200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All of patients receiving intravitreous anti-vascular endothelial growth factors injections at Department of Ophthalmology, Faculty of Medicine, Chiang Mai University, between May 2015 and April 2017, who give consent and agree to follow up within the recommended period

Description

Inclusion Criteria:

  1. More than 18 years of age
  2. Have an eye conditions requiring intravitreous anti-VEGF injections, including neovascular age-related macular degeneration, diabetic macular edema, macular edema due to retinal vein occlusions in one or both eyes
  3. Able to revisit for an eye evaluation at a recommended period (at least 3 weeks following the injection)
  4. No history of uveitis or endophthalmitis in the study eye

Exclusion Criteria:

  • Presence of blepharitis or conjunctivitis in the study at the time of intravitreous injection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Topical antibiotics group
Those who receive topical antibiotics after intravitreous injection as home medication for 7 days.
Drug: Topical antibiotics following injection
Either receive or not receive topical antibiotics following intravitreous injection
No topical antibiotics group
Those who does NOT receive topical antibiotics after intravitreous injection as home medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of endophthalmitis
Time Frame: at least 3 weeks after the injection
Endophthalmitis is defined as a presence of severe inflammation in the anterior chamber and vitreous cavity, associated with pain, redness, or any degree of decreased vision.
at least 3 weeks after the injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiang Mai University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

June 16, 2016

First Submitted That Met QC Criteria

June 20, 2016

First Posted (Estimate)

June 23, 2016

Study Record Updates

Last Update Posted (Estimate)

June 23, 2016

Last Update Submitted That Met QC Criteria

June 20, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPT-2558-02789

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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