Meta-analysis of endophthalmitis after intravitreal injection of anti-vascular endothelial growth factor agents: causative organisms and possible prevention strategies.
Colin A McCannel
https://pubmed.ncbi.nlm.nih.gov/21330939Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID06541574
Prevention of Proliferative Vitreoretinopathy with Intravitreal Methotrexate in Primary Retinal Detachment Repair (FIXER) Trial
Led by Cincinnati Eye Institute, Southwest Ohio · Updated on 2024-09-19
860
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of methotrexate to prevent proliferative vitreoretinopathy (PVR) after primary surgery for rhegmatogenous retinal detachment, which is a significant cause of failure in retinal detachment repairs. PVR involves the growth of scar tissue over the retina and can lead to recurrent detachment and vision loss. This phase 2, double-masked, randomized trial aims to evaluate different methotrexate dosing strategies to reduce PVR occurrence and improve surgical outcomes. Participants are randomly assigned to one of four groups: no methotrexate, standard surgery followed by postoperative intravitreal methotrexate injections at weeks 1, 3, 6, and 10, surgery with intraoperative methotrexate infusion but sham injections afterward, or both intraoperative infusion plus postoperative methotrexate injections. During surgery, methotrexate is infused through a balanced salt solution to deliver the drug directly to the eye, followed by scheduled injections or sham injections depending on the group. The study compares these approaches to determine which methotrexate regimen best prevents PVR. The study involves 11 visits over about 12 months, including preoperative screening, surgery, and multiple postoperative assessments. Participants undergo eye exams, vision tests, and monitoring for PVR development, retinal status, corneal health, and any side effects related to methotrexate. Data on visual acuity, need for repeat surgeries, and complications are collected. Researchers analyze these outcomes at 12 months to assess methotrexate's role in preventing PVR and improving retinal repair success.
CONDITIONS
Brief Title
Prevention of ProliFerative Vitreoretinopathy with Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults age 18 years or older
- Undergoing primary rhegmatogenous retinal detachment surgery with pars plana vitrectomy
- Able to give informed consent
- Surgery performed at Cincinnati Eye Institute in Blue Ash, Ohio
You will not qualify if you...
- Younger than 18 years old
- Pregnant or breastfeeding, or unwilling to use long-term contraception for 12 weeks after surgery if of childbearing potential
- History of serious eye infections, ruptured globe, or significant trauma in the affected eye
- Chronic retinal detachment with symptoms for 6 weeks or longer
- Previous retinal detachment repair with pars plana vitrectomy or scleral buckling surgery (prior pneumatic retinopexy allowed)
- Presence of Grade C proliferative vitreoretinopathy (full thickness retinal folds or subretinal bands)
- Contraindications to methotrexate, including allergy, intolerance, or plans to conceive
- Diminished mental capacity preventing informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 1 to 2 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) prior to surgery
Surgery
Duration - 1 day
Participants undergo vitrectomy surgery for retinal detachment repair with or without intraoperative methotrexate infusion depending on group assignment.
1 surgical visit (in-person)
Treatment
Duration - 10 weeks
Participants receive postoperative intravitreal methotrexate injections or sham injections at weeks 1, 3, 6, and 10 after surgery depending on group assignment. Visual acuity and eye exams are performed to monitor treatment effects and side effects.
4 visits (in-person) at 1, 3, 6, and 10 weeks post-surgery
Follow-up
Duration - Up to 12 months after surgery
Participants are followed with periodic eye exams and visual acuity assessments to monitor recovery, detect proliferative vitreoretinopathy, and evaluate long-term safety and efficacy.
5 visits (in-person) at months 4, 6, 9, and 12 post-surgery
Trial Site Locations
Total: 1 location
1
Cincinnati Eye Institute
Cincinnati, Ohio, United States, 45242
Actively Recruiting
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Research Team
C
Christopher Riemann, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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Published Research Related To This Trial
Endophthalmitis following pars plana vitrectomy: a literature review of incidence, causative organisms, and treatment outcomes.
Vivek Pravin Dave, Avinash Pathengay, Stephen G Schwartz...
https://pubmed.ncbi.nlm.nih.gov/25382968Efficacy and safety of intravitreal methotrexate for vitreo-retinal lymphoma - 20 years of experience.
Zohar Habot-Wilner, Shahar Frenkel, Jacob Pe'er
https://pubmed.ncbi.nlm.nih.gov/33900619An outbreak of Ralstonia pickettii endophthalmitis following intravitreal methotrexate injection.
Himadri Choudhury, Animesh Jindal, Avinash Pathengay...
https://pubmed.ncbi.nlm.nih.gov/26150690Reduced frequency of Intravitreal methotrexate injection lowers the risk of Keratopathy in Vitreoretinal lymphoma patients.
Xian Zhou, Xianjin Zhou, Huimin Shi...
https://pubmed.ncbi.nlm.nih.gov/32397978Intravitreal methotrexate infusion for proliferative vitreoretinopathy.
Ama Sadaka, Robert A Sisk, James M Osher...
https://pubmed.ncbi.nlm.nih.gov/27698550The natural history of untreated rhegmatogenous retinal detachment.
M Ivanisević
https://pubmed.ncbi.nlm.nih.gov/9097312The scleral buckling procedures. I. Surgical techniques and management.
C L SCHEPENS, I D OKAMURA, R J BROCKHURST
https://pubmed.ncbi.nlm.nih.gov/13478226Retinal detachment.
David Steel
https://pubmed.ncbi.nlm.nih.gov/24807890Proliferative vitreoretinopathy: an overview.
J C Pastor
https://pubmed.ncbi.nlm.nih.gov/9716190