Endophthalmitis Post Intravitreal Injections Comparison EPIIC Trial: Pars Plana Vitrectomy Versus Tap and Inject

Who is this study for? Patients with Endophthalmitis
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
St. Michael's Hospital Eye Clinic
RECRUITING
Toronto
Time Frame
Start Date: 2020-03-01
Estimated Completion Date: 2024-07
Participants
Target number of participants: 310
Treatments
Active_comparator: Endophthalmitis Post Intravitreal Injections - TAI
Patients 18 years and older with presumed infectious endophthalmitis after non-steroid intravitreal injections randomized to TAI
Active_comparator: Endophthalmitis Post Intravitreal Injections - PPV
Patients 18 years and older with presumed infectious endophthalmitis after non-steroid intravitreal injections randomized to PPV
Sponsors
Leads: Unity Health Toronto

This content was sourced from clinicaltrials.gov