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NCT05844982 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Visual Impairment and Radiation Retinopathy, sponsored by Jaeb Center for Health Research.

Recruiting
Registry status
Phase 3
Development phase
600
Enrollment target
20
Study locations

NCT05844982: Recruiting Phase 3 study of Visual Impairment and Radiation Retinopathy, sponsored by Jaeb Center for Health Research.

NCT05844982 is a Phase 3 study of Visual Impairment and Radiation Retinopathy that is actively recruiting participants, run by Jaeb Center for Health Research. The registered enrollment target is 600 participants, above the 159-participant average among 7 other Visual Impairment trials with a reported enrollment target (277% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05844982, a Phase 3 study of Visual Impairment and Radiation Retinopathy, is actively recruiting participants, sponsored by Jaeb Center for Health Research.

RECRUITING
Registry status
Phase 3
Development phase
600 participants
Enrollment target
20
Study locations

Study Summary

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.

Primary Outcome

Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.

Interventions

  • DRUG Faricimab
  • DRUG fluocinolone acetonide

Study Locations (20)

Pennsylvania

  • Retina-Vitreous Consultants, Inc. - Monroeville
  • Wills Eye Hospital - Philadelphia
  • Pittsburgh Clinical Trial Consortium - Sewickley

Illinois

  • Northwestern Memorial Group - Chicago
  • IL Eye and Ear Infirmary-University of Illinois at Chicago - Chicago

Michigan

  • Foundation for Vision Research and Retina Specialists of Michigan, P.C. - Grand Rapids
  • Associated Retinal Consultants, P.C. - Royal Oak

Texas

  • Retina Consultants of Texas, PA - Bellaire
  • UT Southwestern Medical Center - Dallas

California

  • Byers Eye Institute at Stanford University - Palo Alto

Connecticut

  • Retina Consultants - Manchester

Florida

  • Retina Associates of Florida, LLC - Tampa

Indiana

  • Midwest Eye Institute - Indianapolis

Trial Details

FieldValue
Enrollment Target 600 participants
Start Date 2023-11-21
Est. Completion 2029-12-26
Phase Phase 3
Jaeb Center for Health Research

119 total trials

What NCT05844982 shows while recruiting

NCT05844982 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 159-participant average among 7 other Visual Impairment trials with a reported enrollment target (277% higher).

The record links to 2 conditions, with Visual Impairment appearing as the primary indexed condition, and to 2 interventions - of which Faricimab is the first listed.

NCT05844982 names 20 study sites across 15 states, led by Pennsylvania, Illinois, Michigan.

Frequently Asked Questions

What is clinical trial NCT05844982 about?

NCT05844982 is a clinical study titled "Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy". 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.

What is the current status of trial NCT05844982?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 600 participants. The study started on 2023-11-21. Estimated completion is 2029-12-26.

What conditions does trial NCT05844982 study?

This clinical trial studies the following conditions: Visual Impairment, Radiation Retinopathy.

What interventions are being tested in trial NCT05844982?

The interventions under investigation include: Faricimab (DRUG), fluocinolone acetonide (DRUG).

Who is sponsoring clinical trial NCT05844982?

This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05844982 being conducted?

This trial has 20 study locations across California, Connecticut, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Visual Impairment

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Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

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Source: ClinicalTrials.gov NCT05844982, the US trial registry maintained by the National Library of Medicine. NCT05844982 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.