NCT02810587

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

June 23, 2016

Status Verified

June 1, 2016

Enrollment Period

1.9 years

First QC Date

June 16, 2016

Last Update Submit

June 20, 2016

Conditions

Endophthalmitis

Keywords

EndophthalmitisIntravitreous injectionanti-vascular endothelial growth factortopical antibiotics

Outcome Measures

Primary Outcomes (1)

  • Incidence of endophthalmitis

    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

Study Arms (2)

Topical antibiotics group

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

Drug: Topical antibiotics following injection

No topical antibiotics group

Those who does NOT receive topical antibiotics after intravitreous injection as home medication.

Interventions

Topical antibiotics following injectionDRUG

Either receive or not receive topical antibiotics following intravitreous injection

Topical antibiotics group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • More than 18 years of age
  • 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
  • Able to revisit for an eye evaluation at a recommended period (at least 3 weeks following the injection)
  • No history of uveitis or endophthalmitis in the study eye

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Voraporn Chaikitmongkol

Muang Chiang Mai, Chiang Mai, 50200, Thailand

RECRUITING

Related Publications (5)

  • 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.

    PMID: 24144453RESULT

  • 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.

    PMID: 21659941RESULT

  • 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.

    PMID: 22480743RESULT

  • 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.

    PMID: 22801859RESULT

  • 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.

    PMID: 20008710RESULT

MeSH Terms

Conditions

Endophthalmitis

Condition Hierarchy (Ancestors)

Eye InfectionsInfectionsEye Diseases

Central Study Contacts

Voraporn Chaikitmongkol, MD

CONTACT

vchaikitmongkol@gmail.com

Onnisa Nanegrungsunk, MD

CONTACT

tiennaneg@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

June 16, 2016

First Posted

June 23, 2016

Study Start

May 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

June 23, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)