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Complexities of running clinical trials in retinal disorders and ways to overcome them

Running clinical trials in retinal disorders can be challenging particularly in a crowded research landscape, due to the complexity of the diseases and the unique characteristics of the patient population. In this blog, we will explore the complexities of running clinical trials in retinal disorders and discuss ways to overcome these challenges based on our experiences from running multiple global retina studies in various indications.

Patient recruitment

One of the biggest challenges in running clinical trials in retinal disorders is patient recruitment and retention, further compounded as many retinal disorders are age-related, which means that patients may have other health issues that make them ineligible for clinical trials.

To overcome this challenge, clinical trial sponsors can work with patient advocacy groups and retinal specialists to identify potential study participants. ICON is uniquely positioned to deliver innovative and fully integrated patient identification, recruitment, and retention solutions. Our Patient Recruitment and Retention experts leverage industry-leading expertise and our in-house digital capabilities to deliver customised, patient-centred outreach campaigns that address study participation barriers, drive patient enrolment, and foster strong relationships with patients to ensure retention and compliance. Our strategies and educational tools allow us to target our messaging for a variety of different audiences (such as physicians, referring physicians, patients, and/or caregivers) in an effort to create awareness of trial specifics in the community of interest.

Additionally, sponsors can consider expanding the geographic scope of the trial to increase the pool of eligible patients. With our ophthalmology trial experience, ICON has established relationships with high-performing retina sites globally that have the experienced staff, capabilities and equipment to conduct these trials. To support and engage site staff and to help drive site performance, training compliance, and inspection readiness we provide ICON’s award-winning site portal FIRECREST that helps site staff navigate complex protocols and minimise the site’s burden. 

Disease progression

Retinal disorders are one of the most common causes of blindness. They can progress slowly, which means that clinical trials may need to be longer than trials in other diseases in order to see meaningful results. This can increase the cost and complexity of running the trial. Additionally, retinal disorders can present a wide range of symptoms and severity, even within the same disease subtype, which can make it difficult to design a trial that can detect meaningful changes in disease progression as well as to interpret the results of the trial and generalise them to the broader patient population.

To address the challenge of disease progression, we can support clinical trial sponsors in considering use of adaptive trial designs that allow for changes in the trial protocol based on interim data analysis. This can help to ensure that the trial is designed to detect meaningful changes in disease progression. 

Endpoint selection and variability

Choosing appropriate endpoints for clinical trials in retinal disorders can be challenging. For example, visual acuity is often used as an endpoint, but it may not be sensitive enough to detect changes in some indications. Additionally, some retinal disorders may have multiple endpoints that need to be considered. Our therapeutic expertise and ophthalmology experience enable us to support clinical trials sponsors to identify appropriate endpoints and tailor strategies that meet your study’s unique needs. In addition, to minimise variability and ensure standardisation in ophthalmology clinical trials, appropriate selection of central reading centres (RC) is key to study success. ICON has built strong relationships with photography and visual acuity reading centres that have experience in multiple protocols spanning a wide variety of retinal diseases. Given the importance of RC data in supporting the study endpoints and the critical path these play in timelines for starting the trial due to site certifications, ICON collaborate with the sponsor and reading centres to develop standardised protocols that can be used across multiple sites.

Patient compliance

Many retinal disorders require frequent follow up at the clinic, which can be burdensome for patients. This can lead to poor compliance with the treatment regimen, which can affect the results of the clinical trial. To address the challenge of patient compliance, clinical trial sponsors can consider using patient-friendly treatment regimens, such as extended-release formulations or less frequent dosing schedules. In addition, when appropriate, ICON also recommends use of an e-diary solution to monitor dosing compliance and supporting study efficacy endpoints. We recommend using a bring-your-own device approach to help patients to easily report study drug dosing. To reduce the financial burden on patients and increase variability of participating in clinical trials, we suggest sponsors provide patients with travel assistance, patient stipend, and other supporting activities based on the targeted patient population. 

Contact us

To learn more about ICON’s services and how can we can support you in running clinical trials in retinal disorders, please refer to your ICON contact or visit www.iconplc.com/contact.

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