Advances in cell and gene therapies and biologics are bringing hope to the millions worldwide who are afflicted by ophthalmic diseases that limit vision and can cause blindness. Innovators in drug development are exploring novel therapies to treat these diseases, and the number of ophthalmology clinical trials involving ocular disorders are expanding rapidly. These studies offer new opportunities for treatment to those willing and able to participate. Understanding how to recruit and engage them and then, crucially, incorporating appropriate participation considerations for those with vision impairment, are fundamental to Parexel’s patient-focused approach. Easing the patient burden through concierge services, caregiver support, and accessible informational materials, for example, are essential elements of our strategy.
Parexel has long been a leader in development of cell and gene therapies for retinal disease
We maintain strong partnerships with patient advocacy groups, including the Foundation Fighting Blindness, which consulted with our team in establishing Parexel’s Inherited Retinal Disease Patient Advisory Council. We have learned from patients that many optometrists and ophthalmologists are unfamiliar with these diseases and unaware of clinical trials. One of our primary objectives is to align with key opinion leaders (KOLs) to help amplify the message and thereby ensure that people diagnosed with a retinal disease have a clear next step. KOLs in our network include ophthalmic specialists from some of the world’s preeminent research institutes and medical centers.
Parexel’s commitment to this therapeutic area has attracted an outstanding team of 10 board-certified ophthalmologists, as well as an alliance of investigators and KOLs,who are devoted to finding treatments for these debilitating conditions. They work in collaboration with our centers of excellence in cell and gene therapies and rare disease, along with biostatisticians, clinical operations and regulatory experts, and site alliance teams.
Our experience spans every phase of the development lifecycle, encompassing novel treatments targeting the more common indications such as wet age-related macular degeneration (wet AMD), geographic atrophy (GA), diabetic macular edema (DME), diabetic retinopathy (DR), retinal vein occlusion (RVO), retinopathy of prematurity (ROP); rare inherited diseases such as retinitis pigmentosa (RP), achromatopsia, cone rod dystrophies (CRD); orbit and inflammatory conditions such as thyroid eye disease and uveitis; anterior segment conditions such as keratitis, corneal neovascularization, and glaucoma.
In the past five years, we have conducted 138 ophthalmology projects, including 63 full-service clinical projects, 42 full clinical trials for retinal disease, with more than 9,800 enrolled patients across over 730 sites in more than 55 countries globally. Parexel has supported the clinical development of five retina products that have achieved market approvals in four different indications, including one for a rare inherited disease.
Global leadership and expertise
Our global ophthalmology team is spearheaded by Dr. Bharti Arya, a highly experienced board-certified ophthalmologist with over 12 years in academic medical practice and a proven track record of supporting regulatory approvals for retinal conditions. Her team includes 9 board-certified ophthalmologists across the globe, providing a comprehensive and diverse perspective on ophthalmology research, who are supported by a large team of ophthalmology-experienced clinical operations staff and strategic feasibility and solutions consultants.
Working with us
At Parexel our core value starts with Patients First. We know a successful trial depends on mapping the RIGHT studies to the RIGHT sites to ensure the RIGHT patients are recruited. Parexel’s Site Alliance program enables us to predict the successful delivery of our clinical trials, and ultimately getting the RIGHT treatments to patients who need them most.
Through our Site Alliance relationships, we have achieved:
- Early feedback on study designs
- In-depth knowledge of sites’ experience, facilities, resources and patient populations
- Open and transparent communications
- Efficient budget/contract negotiations and payments
If you are interested in conducting Ophthalmology trials with Parexel, please create your center/investigator profile utilizing the following link: Parexel Center / Investigator Registration