RECRUITING

Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 Mg) Intravitreal Implants Vs Observation for Prevention of VA Loss Due to Radiation Retinopathy

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Conditions

Radiation RetinopathyVisual ImpairmentVisual AcuityFaricimaFluocinolone Acetonide

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This randomized controlled trial will evaluate the effect of intravitreal faricimab or fluocinolone acetonide (FAc) intravitreal implant compared with observation on long-term visual acuity following treatment of choroidal melanoma with iodine-125 plaque brachytherapy.

Official Title

A Trial Evaluating Intravitreal Faricimab (6.0 Mg) Injections or Fluocinolone Acetonide (0.19 Mg Intravitreal Implants Vs Observation for Prevention of Visual Acuity Loss Due to Radiation Retinopathy

Quick Facts

Study Start:2023-11-21
Study Completion:2029-12-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05844982

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Cynthia Stockdale, MPH
CONTACT
8139758690
DRCRNET@JAEB.ORG

Study Locations (Sites)

Retina Associates of Florida, LLC
Tampa, Florida, 33609
United States
IL Eye and Ear Infirmary-University of Illinois at Chicago
Chicago, Illinois, 60612
United States
Midwest Eye Institute
Indianapolis, Indiana, 46290
United States
University of Iowa Department of Ophthalmology and Visual Sciences
Iowa City, Iowa, 52242
United States
Foundation for Vision Research and Retina Specialists of Michigan, P.C.
Grand Rapids, Michigan, 49546
United States
Associated Retinal Consultants, P.C.
Royal Oak, Michigan, 48073
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Retina Research Institute, LLC
Saint Louis, Missouri, 63128
United States
The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine
Celveland, Ohio, 44120
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
Retina-Vitreous Consultants, Inc.
Monroeville, Pennsylvania, 15146
United States
Retina Consultants of Carolina, PA
Greenville, South Carolina, 29605
United States
Tennessee Retina, PC
Nashville, Tennessee, 37203
United States
Retina Consultants of Texas, PA
Bellaire, Texas, 77401
United States
Texas Retina Associates
Lubbock, Texas, 79424
United States
The Board of Regents of the University of Wisconsin System
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: Jaeb Center for Health Research

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-21
Study Completion Date2029-12-26

Study Record Updates

Study Start Date2023-11-21
Study Completion Date2029-12-26

Terms related to this study

Keywords Provided by Researchers

  • Visual Acuity
  • Radiation retinopathy
  • Faricima
  • Fluocinolone Acetonide

Additional Relevant MeSH Terms

  • Radiation Retinopathy
  • Visual Impairment