Imaging has become crucial for evaluating efficacy and GLP-1 clinical trial eye safety and neurology clinical trials. However, challenges associated with imaging are often overlooked until they affect trial timelines, costs, and outcomes.
Early identification of imaging risks can prevent costly delays and ensure data integrity throughout your study. The stakes are particularly high in therapeutic areas like GLP-1 drugs and neurology, where imaging endpoints provide critical safety and efficacy data.
Clinical trials typically utilize two main categories of imaging:
"The patient acquisition protocol is absolutely critical," explains Dr. Colin Miller of The Bracken Group, a medical imaging expert. "Without proper setup, positioning, or calibration, endpoints may be missed entirely."
Precision becomes paramount for meaningful longitudinal measurements. While baseline measurements require high accuracy, follow-up assessments demand high precision to ensure changes detected reflect therapeutic effects rather than imaging inconsistencies.
Many ocular assessment procedures in preclinical studies mirror those in human trials, but important limitations exist, particularly around subjective measures like visual acuity.
"In humans, we can say 'my vision is blurry' or 'I have double vision,' but unfortunately, these types of assessments we cannot do in preclinical trials because we deal with animals," explains Dr. Simone Iwabe, a Senior Veterinary Ophthalmologist at Altasciences.
For CNS studies, functional analyses like pupillometry (measuring pupil constriction speed and magnitude) or electroretinography (ERG) can detect potential effects on visual pathways, even when structural changes aren't visible during standard examinations.
"Sometimes you do not see any change on ophthalmic examination. However, the function can be compromised," notes Dr. Iwabe. "Functional analysis is very important to detect microscopic changes that you cannot easily detect with regular eye examination."
GLP-1 receptor agonists have been associated with certain ocular events, most notably, non-arteritic anterior ischemic optic neuropathy (NAION), a rare but serious condition that is irreversible and untreatable.
"This is a rare condition... painless, develops somewhat rapidly, sadly irreversible, untreatable," explains Dr. David Nguyen, General Manager and Medical Director at Altasciences. Recent observational studies have found that once-weekly semaglutide doubles the risk of developing NAION in type 2 diabetics.
The Danish health registry conducted a five-year observational study with nearly half a million diabetic patients, confirming this association despite controlling for various external factors.
Comprehensive baseline ocular assessments are essential for study participants, especially since early-phase GLP-1 studies increasingly recruit individuals with obesity or metabolic disorders who may already have underlying vascular changes.
Several operational challenges can impact trial success:
“If you're doing a Phase 3 and have 50 US sites, each could have an individual imaging provider. How do you know there will be quality across all of them?" This question, proposed by Jessica McKenzie, Vice President of Life Sciences at 20/20 Onsite, highlights the complexity of maintaining consistency across multi-site trials.
Based on expert insights, consider these strategic approaches for managing imaging in your GLP-1 and neurology studies:
"It helps the site as well," notes McKenzie. "Once you've identified the site, we're going to go through almost word by word what the protocol's saying. Something as simple as saying 'this will be evaluated by an ophthalmologist versus an optometrist' raises questions about whether you truly need an ophthalmologist or if an optometrist would suffice."
By proactively addressing imaging requirements in GLP-1 and neurology clinical trials, sponsors can reduce risk, maintain data integrity, and avoid costly delays—ultimately protecting trial timelines and participant safety.
A proactive, strategic approach to imaging in GLP-1 and neurology studies is imperative. Engaging imaging vendors early on and implementing standardized acquisition protocols prevents costly delays and protocol amendments and ensures the accurate capture of quantitative and qualitative data. In this context, translating preclinical insights into meaningful, consistent clinical assessments—especially comprehensive baseline ocular evaluations—is essential to mitigating risks such as NAION and ensuring robust trial outcomes.
Addressing operational challenges—from specialist availability to equipment calibration—fortifies data integrity across multiple study sites. As imaging continues to play a critical role in evaluating safety and efficacy, these best practices transform it from a routine technical task into a strategic asset that drives better trial performance and ultimately enhances patient safety and trial success.
Planning a trial with imaging components?
Book a call with 20/20 Onsite to ensure expert support, standardized protocols, and risk mitigation from the start. Let our experts help you overcome imaging challenges and safeguard your data integrity—book your call today.
This article is based on a 20/20 Onsite webinar, “Critical Imaging Risks in GLP-1 and Neurology Studies.” Presenters included Jessica McKenzie (Vice President, Life Sciences, 20/20 Onsite), Dr. David Nguyen, MD, MBA (General Manager and Medical Director, Altasciences), Dr. Simone Iwabe, DVM, PhD, DACVO (Senior Veterinary Ophthalmologist, Altasciences), and Dr. Colin Miller (Founder, The Bracken Group).