NCT05844982 Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy
| NCT ID | NCT05844982 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Jaeb Center for Health Research |
| Condition | Radiation Retinopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2023-11-21 |
| Primary Completion | 2029-12-26 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 600 participants in total. It began in 2023-11-21 with a primary completion date of 2029-12-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05844982 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Radiation Retinopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05844982 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 600 participants.
Is NCT05844982 currently recruiting?
Yes, NCT05844982 is actively recruiting participants. Contact the research team at DRCRNET@JAEB.ORG for enrollment information.
Where is the NCT05844982 trial being conducted?
This trial is being conducted at Palo Alto, United States, Manchester, United States, Tampa, United States, Atlanta, United States and 11 additional locations.
Who is sponsoring the NCT05844982 clinical trial?
NCT05844982 is sponsored by Jaeb Center for Health Research. The trial plans to enroll 600 participants.