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

Visual Impairment Clinical Trial

— AL  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05844982
• Other study ID #: Protocol AL
• Secondary ID: UG1EY014231
• Status: Recruiting
• Phase: Phase 3
• Start date: November 21, 2023
• Est. completion date: November 26, 2028

Study information

• Verified date: May 2024
• Source: Jaeb Center for Health Research
• Contact: Cynthia Stockdale, MPH
• Phone: 8139758690
• Email: DRCRNET[@]JAEB.ORG
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The primary objectives are to compare long-term visual acuity outcomes in eyes that receive repeated treatment with faricimab or fluocinolone acetonide intravitreal implants with those observed initially and treated only if macular edema (ME) develops. The secondary objectives are to determine if repeated treatment with faricimab or fluocinolone acetonide intravitreal implants versus observation can prevent or alter the course of ME from radiation retinopathy and to evaluate the natural history of radiation retinopathy with multimodal imaging including widefield color photographs, widefield fluorescein angiography and OCTA.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: November 26, 2028
• Est. primary completion date: November 26, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria

• Primary uveal melanoma (excluding iris melanoma) receiving primary treatment with plaque brachytherapy
• Absence of unrelated cause of visual loss
• Baseline visual acuity = 34 letters (20/200 Snellen equivalent or better)
• Posterior tumor margin >0 mm from the center of the macula (i.e., tumor is NOT under the geometric center of the fovea)
• Posterior tumor margin >0 mm from the closest disc margin (i.e., tumor is not touching the edge of the optic disc)
• Calculated total dose to center of the macula =30 Gy Key Exclusion Criteria
• Opaque media
• Inability to undergo fluorescein angiography
• Less than 18 years of age
• Prior vitrectomy
• Intraocular pressure (IOP) = 25 mmHg or history of steroid- induced IOP elevation that required treatment at baseline
• IOP = 25 mmHg at randomization or increase in IOP = 8 mmHg from baseline to randomization (following steroid challenge

Related Conditions & MeSH terms

• Radiation Retinopathy
• Retinal Diseases
• Vision Disorders
• Vision, Low
• Visual Impairment

Intervention

Drug:
• Faricimab
6.0 mg intravitreal injection at randomization and every 3 months
• fluocinolone acetonide
0.19 mg fluocinolone acetonide intravitreal implant (Iluvien) at randomization and at 24 months

Locations

Country	Name	City	State
United States	Retina Consultants of Texas, PA	Bellaire	Texas
United States	The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine	Cleveland	Ohio
United States	Retina Consultants of Carolina, PA	Greenville	South Carolina
United States	Midwest Eye Institute	Indianapolis	Indiana
United States	University of Iowa Department of Ophthalmology and Visual Sciences	Iowa City	Iowa
United States	Texas Retina Associates	Lubbock	Texas
United States	Retina-Vitreous Consultants, Inc.	Monroeville	Pennsylvania
United States	Tennessee Retina, PC	Nashville	Tennessee
United States	Oregon Health & Science University	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	Retina Research Institute, LLC	Saint Louis	Missouri
United States	Retina Associates of Florida, LLC	Tampa	Florida

Sponsors (5)

Lead Sponsor	Collaborator
Jaeb Center for Health Research	Alimera Sciences, Genentech, Inc., National Eye Institute (NEI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in visual acuity from baseline	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.	from baseline at 3 years
Primary	Loss of 15 or more letters of visual acuity from baseline	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.	from baseline at 3 years