Boston, MA, November 2024 – 20/20 Onsite continues to expand at the forefront of clinical research, delving deeper into the critical intersection of neurology and ophthalmology. With a growing number of trials and protocols incorporating ophthalmic assessments and eye-related services, driven by increased recognition from the FDA, 20/20 Onsite is leading this innovative field.
The Eye: A Window Into Neurological and Central Nervous System (CNS) Research
Researchers have commonly called the eye the "window to the brain." The eye is a unique, easily accessible organ that provides a direct view into the central nervous system (CNS). Due to its highly vascularized structure, the eye can reflect changes in blood flow, detect early signs of neurodegenerative conditions, and reveal insights into systemic diseases impacting the CNS.
As our understanding of the eye-brain connection deepens, so does the relevance of ophthalmic assessments in clinical trials involving neurological conditions. With an increased focus on ophthalmic endpoints, the FDA now mandates more trials to monitor eye health as a critical biomarker for the safety and efficacy of treatments.
Dr. Katherine Harkins, OD, Director of Optometry at 20/20 Onsite, emphasized the importance of this focus, “Some patients aren't aware that their medication for one ailment can cause a side effect in a completely different part of their body like the eye or that the ailment itself can cause ocular manifestations,” she said. “We've seen this in the past, and we know it will be relevant to future treatment methods. It's crucial that we have an understanding of these effects as we weigh the cost and benefit of emerging treatments.”
Why Are Ophthalmic Assessments Key in Neurology Trials?
Eye assessments are increasingly becoming an essential component in neurology and CNS research for several reasons:
1. Early Detection of Neurological DisordersConditions like Alzheimer’s, Parkinson’s, and Multiple Sclerosis often present subtle signs in the eye before traditional symptoms appear. Monitoring retinal changes, optic nerve health, and other eye parameters can offer early diagnostic clues that aid in understanding disease progression and treatment efficacy.
Dr. Harkins elaborates, “Conditions like Multiple Sclerosis are often first diagnosed at an eye exam. Since our eyes are so important to our daily experience, blurry vision is often the first symptom that leads a patient to seek medical attention. Neurology research with an ophthalmic component is imperative in helping us better understand these diseases to initiate early intervention for improved patient outcomes.”
2. Non-Invasive Access to CNS Health
The eye offers a non-invasive method for observing and monitoring changes in the central nervous system. Techniques like optical coherence tomography (OCT) provide high-resolution images of retinal layers, revealing changes that correlate with neurological conditions. This noninvasive approach allows researchers to gather significant CNS data without the complexities of more invasive techniques.
3. Improved Safety Monitoring
Many therapies for neurological conditions can have ocular side effects. As the FDA focuses on patient safety, mandating ophthalmic assessments helps ensure that drugs don’t negatively impact vision, providing an added layer of patient care and oversight during trials.
Expanding Ophthalmic Trials: A Growing Need
As the landscape of neurology and CNS clinical research evolves, the need for eye-related data is growing. More trials are now incorporating ophthalmic endpoints, covering a range of conditions from migraine and epilepsy to cognitive disorders and mood-related diseases. This aligns with the increasing FDA interest in ophthalmic assessments as a drug safety and efficacy marker.
Neurology & Ophthalmology Trials: What’s Next?
As more biopharma companies recognize the critical link between the eye and the CNS, we anticipate an increase in the demand for ophthalmic assessments in clinical trials. Here’s what 20/20 Onsite sees on the horizon:
- Broader Protocols Involving Ocular Endpoints
We expect to see more protocols incorporating advanced ocular imaging techniques like OCT, wide-field fundus photography, and electroretinography (ERG) as part of standard evaluations in neurology trials. This aligns with the FDA’s recent guidelines emphasizing the importance of comprehensive eye data in assessing drug safety. - Diverse Therapeutic Areas
The scope of conditions requiring eye assessments is broadening. Beyond classic neurology and ophthalmology conditions, other therapeutic areas—such as cardiovascular, metabolic, and autoimmune diseases—now include eye assessments to understand systemic impacts on the central nervous system. - Focus on Patient-Centric Approaches
With our patient-first approach, we play a leading role in decentralized and hybrid clinical trial models. Our patient-centric, point-of-need approach ensures participants have seamless access to the ophthalmic assessments they need, leading to better retention and engagement.
Choosing the Right Partner for CNS and Neurology Trials
Choosing the right ophthalmic partner for your neurology trials is crucial. At 20/20 Onsite, we are uniquely equipped to support the needs of these complex clinical trials. Our approach includes:
- State-of-the-Art Mobile Vision Clinics (MVCs): Equipped with advanced diagnostic tools, our MVCs offer comprehensive ophthalmic assessments and eye-related services at convenient locations, minimizing patient burden and ensuring high-quality data collection. We prioritize data integrity and compliance, adhering to FDA guidelines and ensuring reliable, high-quality, repeatable results in all clinical research.
- On-Site Expertise: Our certified technicians and ophthalmologists are trained in standard and cutting-edge assessments, allowing seamless integration with existing protocols. With tens of thousands of eye assessments completed, including advanced CNS-related evaluations, we bring unmatched expertise to your trial.
- Point-of-Need Assessments: By bringing assessments directly to patients—whether at research sites, their homes, or workplaces—we reduce patient friction and increase trial enrollment, leading to faster timelines and more diverse patient populations. This also improves patient retention during the clinical trial. Our MVCs can operate anywhere (48 states to date), ensuring trials can reach diverse and underserved populations nationwide.
“When you’re conducting a neurology clinical trial that requires an ocular endpoint, the complexity of finding principal investigators (PIs) who have the right patient population and are willing to participate can be difficult,” explained Jessica McKenzie Mays, VP of Life Sciences at 20/20 Onsite. “Adding an ophthalmic assessment—something outside their typical service scope—can lead PIs to decline participation simply because they lack a solution. Preserving the engagement of interested MDs and maintaining access to their patient populations is critical in neurology trials, and having an ophthalmic partner that seamlessly integrates these assessments can make all the difference.”
Partner with 20/20 Onsite
We invite pharmaceutical companies, CROs, and clinical research professionals to connect with us and learn more about our expanding capabilities in neurology and ophthalmology. Let us be your partner in this new era of clinical research and help you accelerate your clinical trials.
Want to know the exact questions you need to answer about your clinical trial to determine whether it's at risk? Contact us today for our risk assessment guide and how we can support your next clinical trial with patient-centric ophthalmic assessments and eye-related solutions.
Want more? Get our free ebook: Key Risk Areas in Non-Ophthalmic Clinical Trials: Ensuring Safety and Compliance with Ophthalmic Assessments.