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

NCT ID: NCT02810587

Last Updated: 2016-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-04-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Endophthalmitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Topical antibiotics group

Those who receive topical antibiotics after intravitreous injection as home medication for 7 days.

Topical antibiotics following injection

Intervention Type DRUG

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.

No interventions assigned to this group

Interventions

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Topical antibiotics following injection

Either receive or not receive topical antibiotics following intravitreous injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiang Mai University

OTHER

Sponsor Role lead

Responsible Party

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Voraporn Chaikitmongkol

Instructor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Voraporn Chaikitmongkol

Muang Chiang Mai, Chiang Mai, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Voraporn Chaikitmongkol, MD

Role: CONTACT

Onnisa Nanegrungsunk, MD

Role: CONTACT

Facility Contacts

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Voraporn Chaikitmongkol, MD

Role: primary

66-53-935512

Onnisa Nanegrungsunk, MD

Role: backup

References

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Storey P, Dollin M, Pitcher J, Reddy S, Vojtko J, Vander J, Hsu J, Garg SJ; Post-Injection Endophthalmitis Study Team. The role of topical antibiotic prophylaxis to prevent endophthalmitis after intravitreal injection. Ophthalmology. 2014 Jan;121(1):283-289. doi: 10.1016/j.ophtha.2013.08.037. Epub 2013 Oct 18.

Reference Type RESULT
PMID: 24144453 (View on PubMed)

Bhatt SS, Stepien KE, Joshi K. Prophylactic antibiotic use after intravitreal injection: effect on endophthalmitis rate. Retina. 2011 Nov;31(10):2032-6. doi: 10.1097/IAE.0b013e31820f4b4f.

Reference Type RESULT
PMID: 21659941 (View on PubMed)

Cheung CS, Wong AW, Lui A, Kertes PJ, Devenyi RG, Lam WC. Incidence of endophthalmitis and use of antibiotic prophylaxis after intravitreal injections. Ophthalmology. 2012 Aug;119(8):1609-14. doi: 10.1016/j.ophtha.2012.02.014. Epub 2012 Apr 4.

Reference Type RESULT
PMID: 22480743 (View on PubMed)

Bhavsar AR, Stockdale CR, Ferris FL 3rd, Brucker AJ, Bressler NM, Glassman AR; Diabetic Retinopathy Clinical Research Network. Update on risk of endophthalmitis after intravitreal drug injections and potential impact of elimination of topical antibiotics. Arch Ophthalmol. 2012 Jun;130(6):809-10. doi: 10.1001/archophthalmol.2012.227. No abstract available.

Reference Type RESULT
PMID: 22801859 (View on PubMed)

Bhavsar AR, Googe JM Jr, Stockdale CR, Bressler NM, Brucker AJ, Elman MJ, Glassman AR; Diabetic Retinopathy Clinical Research Network. Risk of endophthalmitis after intravitreal drug injection when topical antibiotics are not required: the diabetic retinopathy clinical research network laser-ranibizumab-triamcinolone clinical trials. Arch Ophthalmol. 2009 Dec;127(12):1581-3. doi: 10.1001/archophthalmol.2009.304.

Reference Type RESULT
PMID: 20008710 (View on PubMed)

Other Identifiers

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OPT-2558-02789

Identifier Type: -

Identifier Source: org_study_id

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