Whether you need assistance with one part of your clinical trial or a full service UK CRO, PHARMExcel supports sponsors to design and deliver robust, patient centred ophthalmology clinical trials. We work with biotechs, medtech companies, charities and NHS or academic sponsors, providing agile, hands on support from early feasibility through to close out and reporting.
Ophthalmology clinical trials explained
Ophthalmology clinical trials are vital for advancing treatments for conditions such as glaucoma, age related macular degeneration (AMD), diabetic retinopathy and inherited retinal diseases. These studies are technically demanding, often involving specialist imaging, functional vision assessments and long term follow up. Participants may also live with significant visual impairment, so trial design must carefully balance scientific aims with practical, acceptable visit schedules and procedures.
Why ophthalmology trials need specialist expertise
Eye diseases can fluctuate over time or affect each eye differently. This makes it challenging to select endpoints, define meaningful changes in vision and set visit schedules that capture reliable data without overburdening patients or sites. Many participants are older, have comorbidities and may already be receiving intensive treatments such as intravitreal injections, which further increases the demands of trial participation.
In early phase ophthalmology studies, safety oversight is critical. Small cohorts, dose escalation, bilateral versus unilateral treatment and the possibility of irreversible vision changes require cautious planning and close monitoring. Later phase studies bring different complexities, including large volumes of imaging data, central reading requirements and the need for consistent assessments across multiple specialist centres. Working with a CRO that understands these nuances helps to minimise avoidable amendments, recruitment delays and data quality issues.
"It has been a pleasure working with Yvanne and the team. PHARMExcel has been able to work with our clinical research teams to provide bespoke support for a number of trials, including phase 1 trials: the personal approach and attention to detail have given us confidence to ensure patient safety and manage the risks of the Trust acting as Sponsor in particular for the early phase trials."
Client Sponsor
Our approach as your ophthalmology CRO partner
Sponsors choose PHARMExcel when they need a partner that can operate as an extension of their own team rather than a distant service provider. As a smaller organisation, we offer direct access to experienced senior staff and continuity of the same core project team throughout the life of your ophthalmology trial. This allows for faster responses, informed discussions around risk and mitigation, and a collaborative approach when challenges arise.
Our work is underpinned by a formal quality management system and adherence to GCP, but we apply these standards in a way that remains flexible and proportionate to the needs of each study. We take time at the outset to understand your programme, internal ways of working and expectations for communication and reporting. For overseas sponsors, our knowledge of NHS and academic research environments helps to bridge the gap between global plans and UK site realities.
Commercially, our aim is to give you clarity and control. We provide transparent, itemised budgets and can shape our involvement around your internal capabilities, from full service ophthalmology CRO support to focused assistance with defined aspects of your programme.
For each new study, we work with sponsors and investigators to test core assumptions, sense check eligibility criteria and ensure visit schedules and assessments can be delivered reliably at the proposed sites. Because we understand the pressures on ophthalmology services, we focus on pragmatic solutions that support recruitment, retention and high quality data rather than idealised but impractical designs.
As a specialist UK CRO, we are particularly well placed to support sponsors who are new to the UK research environment. We provide clear, candid feedback on feasibility, realistic timelines and the types of centres most suited to your protocol, helping you to plan a trial that works on paper and in practice.
We are a trusted CRO partner with Moorfields Eye Hospital
Here are few of the recent studies in eye disease we have been selected to work on
Phase I Novel Treatment
One of the largest clinical studies of patients with Birdshot Uveitis (eye disease) in the UK running at Moorfields Eye Hospital and University Hospital Birmingham.
Non-Interventional Study
Distance Of Choroid Study-DOCS Study
Conducted at Moorfields Eye Hospital, recruiting patients with neovascular age-related macular degeneration (nAMD).
Epigenetics Study
Single centre study run at Moorfields Eye Hospital to evaluate the immune mechanism of inflammatory eye diseases.
Discuss your next ophthalmology study with us
Whether you are planning a first in human ophthalmology trial in the UK or expanding an existing programme into new sites, PHARMExcel can help you assess feasibility, refine your protocol and plan delivery. To explore how our ophthalmology CRO services could support your next study, contact our team to arrange an initial discussion.
Ophthalmology CRO FAQs
What does an ophthalmology CRO do for sponsors?
An ophthalmology CRO provides specialist support for clinical trials evaluating drugs, advanced therapies, devices or diagnostics for eye conditions. For sponsors, this means help with the following: feasibility assessments, site identification, protocol refinement, regulatory and ethics submissions, project management, clinical monitoring, safety management, medical monitoring, data management, statistics, analysis and reporting.
A CRO with ophthalmology experience understands the specific assessments, specialist ophthalmic image requirements and patient considerations involved, and can translate that knowledge into realistic plans and high quality trial delivery.
Which ophthalmic conditions and indications does PHARMExcel support?
PHARMExcel’s experience spans both common and rare eye conditions, including inflammatory and autoimmune disorders such as age-related macular degeneration (wet and dry), uveitis, diabetic macular edema, vascular and degenerative diseases such as diabetic retinopathy, and complex, low prevalence conditions including Birdshot Uveitis and other rare retinal diseases. Rather than limiting ourselves to a fixed list of diagnoses, we work with sponsors to understand the mechanism of action and target population for each investigational product, then design and deliver studies that fit the needs of those patients and sites.
What trial phases and study types can PHARMExcel support in ophthalmology?
We support ophthalmology studies across the development life cycle, with particular strength in early phase trials where close collaboration and careful safety oversight are essential. Our teams work on Phase I and Phase II studies that assess safety, tolerability and early signals of efficacy, as well as later phase trials delivered across multiple UK centres. We can support interventional drug trials, advanced therapy medicinal product studies, including gene therapy trials, device and diagnostic evaluations, and observational or registry projects where real world data are central.
In which countries can PHARMExcel run ophthalmology clinical trials?
While headquartered in the UK, PHARMExcel has the experience and infrastructure to deliver clinical trials in Europe, USA and internationally, working seamlessly across international sites. Our team supports sponsors with country-specific regulatory pathways, site set-up and oversight to ensure consistent quality across geographies.
How does PHARMExcel ensure quality and regulatory compliance in ophthalmology trials?
Quality and compliance are guided by our ISO 9001 certified quality management system and adherence to GCP. For each ophthalmology study, we develop monitoring and safety plans that reflect the risk profile of the intervention and the patient population. Our teams are trained in regulatory and governance requirements and support sponsors with submissions to local regulatory authorities and the MHRA, ongoing reporting and preparation for audits or inspections.
Throughout the trial, we maintain clear documentation and oversight so sponsors can be confident in the integrity of their data.
How does working with a smaller UK CRO benefit ophthalmology studies?
Being a smaller, UK based CRO allows us to offer sponsors direct access to the people who know their ophthalmology study in detail. Decisions are made quickly, communication lines are short, and the same core team stays involved from start up to close out. Our familiarity with NHS and academic research environments helps us to anticipate practical challenges and align study plans with local care pathways and capacity. For many sponsors, this combination of specialist expertise, agility and personal engagement is a better cultural fit than working with a very large, global provider.