Ophthalmology
Our team's expertise in ophthalmology includes navigating complex regulatory pathways for innovative therapies.
At iNGENū CRO, we understand the intricate nature of ophthalmology clinical trials and the vital role they play in advancing treatments for a wide range of eye conditions.
Our team brings extensive expertise in the design, execution, and management of ophthalmology studies, ensuring that all aspects of the research process are handled with precision and care.
Our clinical team has comprehensive experience covering various ophthalmic conditions, including:
- Age-related Macular Degeneration (AMD)
- Diabetic Retinopathy
- Glaucoma
- Cataracts
- Retinal Vein Occlusion (RVO)
- Dry Eye Syndrome
- Uveitis
Pain points associated with clinical trials in opthalmology
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Patient Recruitment and Retention: Identifying and enrolling patients with specific eye conditions can be difficult, particularly when the symptoms are mild or the condition is rare. Ensuring long-term participation is essential but challenging.
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Specialized Imaging and Diagnostics: Ophthalmic studies often require advanced imaging techniques such as Optical Coherence Tomography (OCT), fundus photography, and fluorescein angiography. Consistency and accuracy in these diagnostics are critical.
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Outcome Measures: Many ophthalmic conditions rely on subjective patient-reported outcomes (PROs) and visual acuity measures, which can introduce variability in data collection and interpretation.
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Regulatory Requirements: Ophthalmology trials often involve complex regulatory pathways, particularly when dealing with innovative treatments such as gene therapy, biologics, or medical devices.
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Safety Monitoring: Given the sensitivity of the eye and the potential for adverse events, particularly in surgical interventions or invasive procedures, vigilant safety monitoring is crucial.
How iNGENū addresses these pain points
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Targeted Recruitment Strategies: iNGENū utilizes a combination of advanced patient databases, partnerships with ophthalmology clinics, and engagement with patient advocacy groups to identify and enroll suitable candidates efficiently. We prioritize patient-centric trial designs to enhance recruitment and retention.
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State-of-the-Art Imaging: We partner with leading ophthalmology centers equipped with the latest imaging technologies. Our trials incorporate standardized imaging protocols and training for site staff to ensure consistent data collection across all sites.
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Objective and Subjective Outcomes: We design trials that incorporate both objective measures (e.g., imaging biomarkers, visual function tests) and validated subjective outcomes. Our statisticians are adept at analyzing complex data sets to account for variability in patient-reported outcomes.
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Regulatory Expertise: iNGENū's regulatory affairs team is well-versed in the specific requirements for ophthalmology trials. We provide comprehensive support, from IND/IDE submissions to navigating the approval processes for innovative treatments.
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Robust Safety Monitoring: Our safety protocols include continuous monitoring, real-time data analysis, and a dedicated safety board to oversee the well-being of participants. We also emphasize clear communication with all stakeholders to manage risks effectively.