NCT04035369

Brief Summary

Intravitreal injection (IVI) is an ophthalmological procedure used worldwide to treat ocular conditions. Its use has been steadily increasing for several years, because this method of drug delivery minimizes systemic exposure and allows for intraocular drug levels not achievable through systemic or topical drug administration. IVI of agents such as anti-vascular endothelial growth factor (anti-VEGF) or corticosteroids are efficacious for several retinal diseases, including age-related macular degeneration, macular edema due to retinal vein occlusion or diabetic macular edema, and uveitis, among others. But IVIs are not without their risk of complications and the most feared of which is infectious endophthalmitis, which can occur following intravitreal injections and has potentially devastating visual consequences, including loss of vision and/or the eye itself. Although endophthalmitis´s incidence ranges from 0-0.2% per infection, the cumulative risk for patients under sequential treatment may equate to more than 1% after 2 years of treatment. Endophthalmitis management following IVIs generally consists of a vitreous tap and inject (TAI) and/or a pars plana vitrectomy (PPV) with intravitreal injection of antibiotics. However, there is no consensus on the optimal treatment of IVI-related endophthalmitis. Thus, an established treatment protocol for IVI-related endophthalmitis is warranted to optimize patient outcomes. The aim of this study is to determine whether PPV or TAI is superior for the treatment of IVI-related endophthalmitis.

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
310

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

June 19, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 29, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

4.3 years

First QC Date

June 19, 2019

Last Update Submit

May 9, 2023

Conditions

Endophthalmitis

Outcome Measures

Primary Outcomes (1)

  • Visual acuity outcomes

    To compare visual acuity (VA) measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) testing between PPV and TAI for treatment of endophthalmitis at 12-months post-treatment We hypothesize that PPV will be superior to TAP in terms of ETDRS visual outcomes at the 12-month time point.

    12 months

Secondary Outcomes (13)

  • Early visual acuity outcomes

    3 and 6 months

  • Visual outcomes related to baseline visual acuity

    3, 6 and 12 months

  • The Visual Function Questionnaire (VFQ-25) outcomes

    3, 6 and 12 months

  • The 36-Item Short-From Survey (SF-36)

    Baseline, 1 month and 12 months

  • Number of participants with treatment-related adverse events as assessed by OCT

    3, 6 and 12 months

  • +8 more secondary outcomes

Study Arms (2)

Endophthalmitis Post Intravitreal Injections - TAI

ACTIVE COMPARATOR

Patients 18 years and older with presumed infectious endophthalmitis after non-steroid intravitreal injections randomized to TAI

Procedure: Tap and Inject (TAI)

Endophthalmitis Post Intravitreal Injections - PPV

ACTIVE COMPARATOR

Patients 18 years and older with presumed infectious endophthalmitis after non-steroid intravitreal injections randomized to PPV

Procedure: Pars Plana Vitrectomy (PPV)

Interventions

Tap and Inject (TAI)PROCEDURE

Patients randomized to the TAI group will have a 0.2 mL vitreous specimen collected and a 0.1 mL anterior chamber paracentesis performed to be sent for standard cultures, Gram stain, and sensitivities. Intravitreal injection of the following antibiotics: Vancomycin 1.0 mg/0.1 mL, ceftazidime 2.25 mg/0.1 mL (amikacin 400 mcg/0.1 mL instead of Ceftazidime if severe penicillin allergy) and an intravitreal injection of dexamethasone 400 mcg/0.1 mL

Also known as: TAI
Endophthalmitis Post Intravitreal Injections - TAI
Pars Plana Vitrectomy (PPV)PROCEDURE

Patients randomized to the PPV group will undergo a three-port PPV. The patient should be added to the OR list as an A-case (maximum 6 hours wait) and no intravitreal injection should be performed prior to the surgery. A 0.1 mL aqueous humor simple immediately before the surgery. A 0.2 mL vitreous specimen will be obtained after the sclerotomies are placed. The PPV procedure should be limited to core vitrectomy, air fluid exchange and intravitreal injections (antibiotics and dexamethasone - Vancomycin 1.0 mg/0.1 mL, ceftazidime 2.25 mg/0.1 mL or amikacin 400 mcg/0.1 mL instead of Ceftazidime if severe penicillin allergy and an intravitreal injection of dexamethasone 400 mcg/0.1 mL). Other tamponades such as silicone oil should be avoided if possible. The PPV will then be completed by the surgeon and the vitreous specimen will be sent for standard cultures, Gram stain, and sensitivities.

Also known as: PPV
Endophthalmitis Post Intravitreal Injections - PPV

Eligibility Criteria

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

You may qualify if:

  • Patients 18 years and older
  • Intravitreal injections other than intravitreal steroids within the last 2 weeks
  • Diagnosed with presumed infectious endophthalmitis: patients presenting with vision loss and hypopyon
  • Visual acuity of light perception or better
  • Safety concern by the treating physician for patients enrolled in the study. That is to say, if the physician feels a patient's outcomes would be better with one intervention over the other, this patient should not be enrolled in the study.

You may not qualify if:

  • Prior intraocular surgery in the study eye within the last 3 months
  • Prior penetrating ocular trauma
  • Bleb or prior glaucoma filtration surgery in the study eye
  • Patients with other ocular conditions limiting vision in the study eye other than the retinal pathology for which they receive intravitreal injections for e.g. anterior segment pathology, retinal detachments, end-stage glaucoma
  • Previous vitreo-retinal surgery.
  • Unwilling or unable to follow or comply with all study-related procedures or sign consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital Eye Clinic

Toronto, Ontario, M5C2T2, Canada

RECRUITING

Related Publications (6)

  • Chaudhary KM, Romero JM, Ezon I, Fastenberg DM, Deramo VA. Pars plana vitrectomy in the management of patients diagnosed with endophthalmitis following intravitreal anti-vascular endothelial growth factor injection. Retina. 2013 Jul-Aug;33(7):1407-16. doi: 10.1097/IAE.0b013e3182807659.

    PMID: 23492945BACKGROUND

  • Xu K, Chin EK, Bennett SR, Williams DF, Ryan EH, Dev S, Mittra RA, Quiram PA, Davies JB, Parke DW 3rd, Johnson JB, Cantrill HL, Almeida DRP. Endophthalmitis after Intravitreal Injection of Vascular Endothelial Growth Factor Inhibitors: Management and Visual Outcomes. Ophthalmology. 2018 Aug;125(8):1279-1286. doi: 10.1016/j.ophtha.2018.01.022. Epub 2018 Feb 21.

    PMID: 29477689BACKGROUND

  • Results of the Endophthalmitis Vitrectomy Study. A randomized trial of immediate vitrectomy and of intravenous antibiotics for the treatment of postoperative bacterial endophthalmitis. Endophthalmitis Vitrectomy Study Group. Arch Ophthalmol. 1995 Dec;113(12):1479-96.

    PMID: 7487614BACKGROUND

  • Haddock LJ, Ramsey DJ, Young LH. Complications of subspecialty ophthalmic care: endophthalmitis after intravitreal injections of anti-vascular endothelial growth factor medications. Semin Ophthalmol. 2014 Sep-Nov;29(5-6):257-62. doi: 10.3109/08820538.2014.959616.

    PMID: 25325851BACKGROUND

  • Moss JM, Sanislo SR, Ta CN. Antibiotic susceptibility patterns of ocular bacterial flora in patients undergoing intravitreal injections. Ophthalmology. 2010 Nov;117(11):2141-5. doi: 10.1016/j.ophtha.2010.02.030. Epub 2010 Jun 18.

    PMID: 20561687BACKGROUND

  • Irigoyen C, Ziahosseini K, Morphis G, Stappler T, Heimann H. Endophthalmitis following intravitreal injections. Graefes Arch Clin Exp Ophthalmol. 2012 Apr;250(4):499-505. doi: 10.1007/s00417-011-1851-1. Epub 2011 Nov 3.

    PMID: 22048244RESULT

MeSH Terms

Conditions

Endophthalmitis

Interventions

Paracentesis

Condition Hierarchy (Ancestors)

Eye InfectionsInfectionsEye Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDrainageTherapeuticsPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Study personnel involved in visual acuity assessments and imaging will be masked to group assignment.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2019

First Posted

July 29, 2019

Study Start

March 1, 2020

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

May 11, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)