Fluocinolone acetonide intravitreal implant or faricimab (6.0 mg) injections versus observation will be studied for the prevention of visual acuity loss due to radiation retinopathy
Alimera Sciences Inc. announced today it has entered into an agreement with the Jaeb Center for Health Research Foundation Inc. (JCHR), acting on the behalf of the DRCR Retina Network to support and provide fluocinolone acetonide intravitreal implant (Iluvien) 0.19 mg sustained release intravitreal implant for “A Randomized Clinical 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 (Protocol AL)”.
According to the company, the study, which is expected to begin in Q1 2023, is planned to include 600 participants with primary choroidal melanoma receiving treatment with plaque brachytherapy.
The study, the company noted in its news release, will assess development of macular edema and associated long-term visual acuity effects of consistent and continuous release of corticosteroid or repeated injections of anti-VEGF initiated near the time of radiation therapy compared to observation until macular edema develops in patients at risk for radiation retinopathy.
“We are very excited to be working with this prestigious network of physicians in evaluating ILUVIEN’s potential to address another unmet need affecting the retina,” Rick Eiswirth, president and CEO of Alimera, said in a statement. “When utilized as baseline therapy, as in our New Day Study (NCT04469595) for diabetic macular edema, we believe Iluvien’s continuous microdosing deliver may prevent, delay or reduce the occurrence of the complication of radiation retinopathy and consequent vision loss when used in patients treated with plaque brachytherapy.”
About Radiation Retinopathy
Radiation retinopathy (RR) is a common complication after Iodine-125 plaque brachytherapy for choroidal melanoma. Although the initial radiation insult is immediate, clinical onset of RR is not seen until many months later and RR frequently progresses over time to profound vision loss.
The company noted that the Collaborative Ocular Melanoma Study reported that at 3 years, 45% of patients have visual acuity 20/200 or worse. A treatment that prevents the development of RR, or dampens its severity, would have important consequences for many of these eyes that may be successfully treated for choroidal melanoma but will likely develop severe RR and loss of vision over time.