This review highlights challenges in clinical trials for wet age-related macular degeneration, suggesting the need for improved personalized medicine and regulatory frameworks.
Background: Wet Age-Related Macular Degeneration (wAMD) is a major contributor to severe vision impairment among older adults. Although anti-VEGF therapies are available, the condition continues to pose a considerable public health issue because of challenges related to effectiveness, recurrence, and the burden of treatment. Objectives: This review seeks to examine the latest trends, recent developments, and ongoing challenges in clinical trials for wAMD. Additionally, it assesses the impact of innovative therapeutic approaches and regulatory obstacles on the results of clinical trials. Methodology: An extensive literature search was conducted using databases such as PubMed, Scopus, and ClinicalTrials.gov. Relevant clinical trials, systematic reviews, and regulatory guidelines from the last decade were analyzed to assess emerging trends, key barriers, and future directions in wAMD clinical research. Results: The analysis revealed a trend towards personalized medicine, gene and cell therapies, and continuous drug delivery systems in wAMD clinical trials. Nevertheless, significant obstacles remain, such as difficulties in patient recruitment, elevated trial expenses, absence of predictive biomarkers, and the intricacies involved in assessing long-term efficacy. Additionally, variations in regulations and ethical issues hinder the seamless advancement of trials. Conclusion: Despite advancements in clinical research for wAMD through innovative therapies and enhanced designs, it is vital to address current challenges to effectively translate promising treatments into successful real-world applications. Cooperative initiatives among researchers, clinicians, regulatory agencies, and the industry are critical for refining trial frameworks and improving patient outcomes.
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Mishra et al. (2025) studied this question.
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