Tuesday, March 18 2025
8.00 am CHECK-IN & COFFEE + LIGHT BREAKFAST
9.00 am – 12.00 am WORKSHOP A
Optimizing Clinical Trial Design for Wet AMD & Diabetic Eye Disease Therapies
Synopsis
This workshop will delve into advanced strategies for designing clinical trials in Wet AMD and diabetic eye disease. By focusing on patient-specific factors, drug delivery challenges, and adaptive trial models, participants will gain the tools needed to enhance trial efficiency and therapeutic success.
- Structuring trial arms to capture diverse patient populations and ensure comprehensive efficacy and safety data
- Evaluating drug delivery methods to optimize treatment efficacy and patient adherence
- Ensuring consistent drug formulation across all trial phases to maintain integrity and comparability of results
- Applying advanced statistical methods to ensure trials are adequately powered for meaningful outcomes
- Analyzing molecular pathways to tailor therapies based on patient-specific disease mechanisms and improve predictive success
- Leveraging adaptive clinical trial designs to combine phases, reducing timelines and costs while maintaining control over adverse effects through single-eye treatments
12.00 pm LUNCH & NETWORKING
1.00 pm – 4.00 pm WORKSHOP B
Analysis of Biomarker Approaches & Clinical Endpoints for Neovascular Retinal Disorders
Synopsis
This workshop will focus on the critical role of biomarkers and clinical endpoints in the development of therapies for neovascular retinal disorders, including diabetic retinopathy (DR) and wet age-related macular degeneration (AMD). Participants will engage in discussions surrounding the complexities of endpoint selection, the advancements in imaging technologies, and the implications of emerging biomarkers for drug development.
- Explore the limitations of traditional anatomical endpoints in clinical trials for diabetic retinopathy (DR) and wet AMD, discussing the current landscape of surrogate biomarkers to expedite results
- Identify emerging biomarkers in neovascular retinal disorders and their potential roles in clinical development
- Discuss the challenges of selecting and validating biomarkers, particularly regarding imaging technologies like OCTA and microperimetry
- Evaluate the causal relationships between biomarkers and disease progression to optimize drug development and validate surrogate biomarkers
- Highlight the impact of technological advancements on biomarker identification and the role of AI in data analysis
- Emphasize the importance of reliable imaging devices and methodologies for consistent biomarker assessment and endpoint validation