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Compares treatment options for Radiation Retinopathy
Official title Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy
ClinicalTrials.gov ID: NCT05844982
What this study is testing
What is Faricimab?
Faricimab is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for radiation retinopathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Key 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)
You likely can't join if
- 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
See the full eligibility criteria
- Key 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- Manchester, Connecticut, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
- Grand Rapids, Michigan, United States
- Royal Oak, Michigan, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- Celveland, Ohio, United States
- Portland, Oregon, United States
- Monroeville, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Sewickley, Pennsylvania, United States
- Greenville, South Carolina, United States
- Hixson, Tennessee, United States
- Nashville, Tennessee, United States
- Bellaire, Texas, United States
+ 3 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; Manchester, Connecticut, United States; Tampa, Florida, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Indianapolis, Indiana, United States and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.