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

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ClinicalTrials.gov Identifier: NCT02810587
Recruitment Status : Unknown
Verified June 2016 by Voraporn Chaikitmongkol, Chiang Mai University.
Recruitment status was:  Recruiting
First Posted : June 23, 2016
Last Update Posted : June 23, 2016
Sponsor:
Information provided by (Responsible Party):
Voraporn Chaikitmongkol, Chiang Mai University

Brief Summary:
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).

Condition or disease Intervention/treatment
Endophthalmitis Drug: Topical antibiotics following injection

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.

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Incidence of Endophthalmitis After Intravitreous Anti-vascular Endothelial Growth Factor Injections Comparison Between Patients Receiving Versus Not Receiving Topical Antibiotics Following the Injections
Study Start Date : May 2015
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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.



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT02810587


Contacts
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Contact: Voraporn Chaikitmongkol, MD vchaikitmongkol@gmail.com
Contact: Onnisa Nanegrungsunk, MD tiennaneg@gmail.com

Locations
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Thailand
Voraporn Chaikitmongkol Recruiting
Muang Chiang Mai, Chiang Mai, Thailand, 50200
Contact: Voraporn Chaikitmongkol, MD    66-53-935512    vchaikitmongkol@gmail.com   
Contact: Onnisa Nanegrungsunk, MD       tiennaneg@gmail.com   
Sponsors and Collaborators
Chiang Mai University
Publications of Results:
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Responsible Party: Voraporn Chaikitmongkol, Instructor, Chiang Mai University
ClinicalTrials.gov Identifier: NCT02810587    
Other Study ID Numbers: OPT-2558-02789
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Voraporn Chaikitmongkol, Chiang Mai University:
Endophthalmitis
Intravitreous injection
anti-vascular endothelial growth factor
topical antibiotics
Additional relevant MeSH terms:
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Endophthalmitis
Eye Infections
Infection
Eye Diseases
Anti-Bacterial Agents
Anti-Infective Agents