Endophthalmitis Clinical Trial
— EPIICOfficial title:
Endophthalmitis Post Intravitreal Injections Comparison EPIIC Trial: Pars Plana Vitrectomy Versus Tap and Inject
NCT number | NCT04035369 |
Other study ID # | EPIIC |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2020 |
Est. completion date | July 2024 |
Verified date | May 2023 |
Source | Unity Health Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 310 |
Est. completion date | July 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | St. Michael's Hospital Eye Clinic | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Unity Health Toronto |
Canada,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Early visual acuity outcomes | Compare ETDRS VA between treatment modalities at 3 and 6 months. | 3 and 6 months | |
Secondary | Visual outcomes related to baseline visual acuity | Subgroup analysis between treatment groups for patients with different pre-endophthalmitis baseline vision based on vision thresholds of 20/40 or better, 20/50 to 20/200, and 20/400 to CF, performed at 3 months, 6 months, and 12 months: the most recently recorded pre-endophthalmitis Snellen visual acuity will be obtained from patient charts and used as the pre-endophthalmitis vision baseline | 3, 6 and 12 months | |
Secondary | The Visual Function Questionnaire (VFQ-25) outcomes | Compare scores from the Visual Function Questionnaire (VFQ-25) between treatment modalities at 3 months, 6 months, and 12 months. The VFQ-25 consists of a base set of 25 vision targeted questionnaire. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. In this format scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score. | 3, 6 and 12 months | |
Secondary | The 36-Item Short-From Survey (SF-36) | Compare scores from the 36-Item Short-From Survey (SF-36) between treatment modalities at baseline, 1 month and 1 year. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. | Baseline, 1 month and 12 months | |
Secondary | Number of participants with treatment-related adverse events as assessed by OCT | The participants will be evaluated as "Yes" or "No" to de following OCT findings: 1- Cystoid macular edema (CME); 2- Subretinal fluid (SRF); 3- Intraretinal fluid (IRF); 4-Epiretinal membrane (ERM); 5-Macular hole (MH) | 3, 6 and 12 months | |
Secondary | Number of participants with treatment-related adverse events as assessed by Optos retinal photos | The participants will be evaluated as "Yes" or "No" to de following Optos Photos: 1-Retina status attached; 2-Epiretinal membrane (ERM); 3-Cystoid macular edema (CME); 4-Retinal Ischemia; 5-Retinal hemorrhages | 3 and 12 months | |
Secondary | Number of participants with treatment-related adverse events as assessed by Autofluorescence (AF) images | The participants will be evaluated as "Yes" or "No" to de following Autofluorescence: 1-Retina status attached; 2-Retinal lesion activity; 3-Retinal scar | 3 months | |
Secondary | Complications and retreatment | Comparison of complications and/or need for retreatment following each intervention | 12 months | |
Secondary | Aqueous humor and vitreous sample Culture | Standard cultures: 1=Coagulase-negative staphylococci; 2=Staphylococcus Aureus; 3= Staphylococcus Epidermidis; 4=Streptococcus Pneumoniae; 5=H. influenzae; 6=Other; 7=No growth | Baseline | |
Secondary | Aqueous humor and vitreous sample Gram stain | Gram stain: ( ) positive; ( ) negative; ( ) fungi; ( ) organisms not detected | Baseline | |
Secondary | Aqueous humor and vitreous sample Sensitivities | Antibiotics sensitivities: ( ) vancomycin; ( )ceftazidime; ( ) gatifloxacine; ( ) ofloxacin ( ) polymyxin; ( ) bacitracin; ( ) trimethoprim; ( ) cefazolin; ( ) ceftriaxone; | Baseline | |
Secondary | Changes in visual acuity | Analysis of the changes in the visual acuity during the study | 3, 6 and 12 months | |
Secondary | Recovery to the pre-endophthalmitis visual acuity | Analysis in patients recovering the pre-endophthalmitis visual acuity and timing (in months) from treatment to recovery. | 3, 6 and 12 months |
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