Endophthalmitis Post Intravitreal Injections Comparison EPIIC Trial: Pars Plana Vitrectomy Versus Tap and Inject
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Unity Health Toronto
- Enrollment
- 310
- Locations
- 2
- Primary Endpoint
- Visual acuity outcomes
Study Overview
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.
Detailed Description
Background The use of intravitreal injections (IVIs) 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. Intravitreal injection (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. 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.
Objectives and Innovation The aim of this study is to determine whether PPV or TAI is superior for the treatment of IVI-related endophthalmitis. The primary objective is to compare final visual acuity (VA) between treatment regimens at 12-months post-treatment. Secondary objectives include subgroup analysis between patients of varying VAs and demographic variables, aqueous humor analysis, comparison of complications and/or need for retreatment, and comparison of anatomic outcomes by autofluorescence, optical coherence tomography (OCT), and OCT angiography (OCTA) imaging.
Methods Consenting patients 18 years and older with presumed infectious endophthalmitis after non-steroid intravitreal injections will undergo stratified block randomized into the PPV or TAI intervention group based on their baseline VA in the study eye. Patient demographics will be collected and a standard ocular examination at baseline will be performed.
Randomization Stratified block randomization (block size = 4) will be used to randomize patients into one of the two interventions according to baseline visual acuity in the study eye (worse than or equal to hand motions and counting fingers or worse) A computer-generated block randomization design will be used to create the randomization list, which will be uploaded to the randomization system (RedCap). Once a patient has consented and been enrolled in the study, the local study coordinator will access the randomization system to enter the patient's assigned study ID and visual acuity status. The treatment group assignment will then be displayed by randomization system to the study coordinator who will inform the recruiting physician.
Masking Study personnel involved in visual acuity assessments and imaging will be masked to group assignment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Study personnel involved in visual acuity assessments and imaging will be masked to group assignment.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Visual acuity outcomes
Time Frame: 12 months
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.
Secondary Outcomes
- The Visual Function Questionnaire (VFQ-25) outcomes(3, 6 and 12 months)
- Number of participants with treatment-related adverse events as assessed by Optos retinal photos(3 and 12 months)
- Number of participants with treatment-related adverse events as assessed by Autofluorescence (AF) images(3 months)
- Recovery to the pre-endophthalmitis visual acuity(3, 6 and 12 months)
- The 36-Item Short-From Survey (SF-36)(Baseline, 1 month and 12 months)
- Changes in visual acuity(3, 6 and 12 months)
- Aqueous humor and vitreous sample Gram stain(Baseline)
- Number of participants with treatment-related adverse events as assessed by OCT(3, 6 and 12 months)
- Aqueous humor and vitreous sample Sensitivities(Baseline)
- Early visual acuity outcomes(3 and 6 months)
- Visual outcomes related to baseline visual acuity(3, 6 and 12 months)
- Complications and retreatment(12 months)
- Aqueous humor and vitreous sample Culture(Baseline)