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June 4, 2018updated 13 Jul 2022 9:14am

Clearside reports positive topline results in TYBEE trial

Clearside Biomedical has reported positive topline results from the TYBEE trial, a Phase ll clinical study designed to analyse suprachoroidal CLS-TA with intravitreally administered Eylea (aflibercept) in patients with diabetic macular edema (DME).

Clearside Biomedical has reported positive topline results from the TYBEE trial, a Phase ll clinical study designed to analyse suprachoroidal CLS-TA with intravitreally administered Eylea (aflibercept) in patients with diabetic macular edema (DME).

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As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
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The multicentre, randomised, masked, controlled trial had a six-month-long evaluation period and enrolled 71 treatment-naïve patients.

As part of the trial, patients were randomised at 1:1 ratio to receive either quarterly treatments of suprachoroidal CLS-TA together with intravitreal Eylea (the combination arm) or four monthly treatments of intravitreal Eylea plus a sham suprachoroidal procedure (the control arm).

Patients in either arm received intravitreal Eylea treatment at months four and five as needed.

The TYBEE trial met its primary objective of mean improvement in best corrected visual acuity (BCVA) from baseline over six months as measured using the Early Treatment of Diabetic Retinopathy Trial (ETDRS) scale.

“The multicentre, randomised, masked, controlled trial had a six-month long evaluation period and enrolled 71 treatment naïve patients.”

Patients in the combination arm have also gained an average of 12.3 ETDRS letters compared to 13.5 ETDRS letters in the Elyea alone control arm.

Furthermore, the administration of suprachoroidal CLS-TA along with intravitreal Eylea met a key secondary objective of the trial with a mean reduction from baseline of 208 microns in central subfield thickness (CST) of the retina at six months, compared to a 177 micron mean reduction in the control arm.

A total of 93% of patients in the combination arm also experienced more than 50% reduction in excess CST at six months, compared to 73% of patients in the control arm.

The trial also found that suprachoroidal CLS-TA used together with intravitreal Eylea was generally well tolerated, with no treatment-related serious adverse events reported through the trial’s 24-week evaluation period.

It reported elevated intraocular pressure adverse events for 8.3% of patients in the combination arm, compared to 2.9% of patients in the control arm.

Both arms of the trial reported cataract adverse events, with about 5.6% of patients in the combination arm and 2.9% of patients in the control arm developing cataracts.

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As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
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