Clinical trial NCT05844982: Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 Mg) Intravitreal Implants Vs Observation for Prevention of VA Loss Due to Radiation Retinopathy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Radiation Retinopathy
Visual Impairment
Keywords: Visual Acuity
Radiation retinopathy
Faricima
Fluocinolone Acetonide
Lead sponsor: Jaeb Center for Health Research
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
name: National Institutes of Health (NIH)
name: Alimera Sciences
name: Genentech, Inc.
First posted: 2023-05-06
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in visual acuity from baseline
timeFrame: from baseline at 3 years
measure: Loss of 15 or more letters of visual acuity from baseline
timeFrame: from baseline at 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Byers Eye Institute at Stanford University
state: California
city: Tampa
country: United States
facility: Retina Associates of Florida, LLC
state: Florida
city: Chicago
country: United States
facility: IL Eye and Ear Infirmary-University of Illinois at Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Eye Institute
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Department of Ophthalmology and Visual Sciences
state: Iowa
city: Grand Rapids
country: United States
facility: Foundation for Vision Research and Retina Specialists of Michigan, P.C.
state: Michigan
city: Royal Oak
country: United States
facility: Associated Retinal Consultants, P.C.
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Retina Research Institute, LLC
state: Missouri
city: Celveland
country: United States
facility: The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Monroeville
country: United States
facility: Retina-Vitreous Consultants, Inc.
state: Pennsylvania
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
city: Greenville
country: United States
facility: Retina Consultants of Carolina, PA
state: South Carolina
city: Nashville
country: United States
facility: Tennessee Retina, PC
state: Tennessee
city: Bellaire
country: United States
facility: Retina Consultants of Texas, PA
state: Texas
city: Lubbock
country: United States
facility: Texas Retina Associates
state: Texas
city: Madison
country: United States
facility: The Board of Regents of the University of Wisconsin System
state: Wisconsin
Study officials:
References: