Global trial equity: How LMIC data is reshaping US ophthalmology research !!!

 

1. Global Trial Equity: LMIC Data Reshaping US Ophthalmology
An expert Q&A with Dr. Daniela Ferrara discusses how data from low- and middle-income countries (LMICs) is being used to strengthen clinical trial design, improve demographic representation, and inform innovation in U.S. ophthalmology research. The piece highlights the ethical importance of diverse populations in evidence generation and points to AI’s role in harmonizing global datasets for better clinical insights. Ophthalmology Times

2. AI & Imaging Transforming Retinal Care
At AAO 2025, advances like AI-powered home OCT and refined imaging technologies were shown to revolutionize how retinal diseases are detected and monitored—underscoring innovation that increasingly relies on broader, diverse clinical data. Ophthalmology Times

3. FDA Fast Track & Novel Treatments
The US FDA awarded Fast Track designation to Epion Therapeutics’ EpiSmart cross-linking system for keratoconus, representing progress in ophthalmic therapy development that may benefit from trial data diversity globally. Ophthalmology Times

4. Gene Therapy Trial Advances
The FDA also cleared an IND for Complement Therapeutics’ CTx001 gene therapy for geographic atrophy, enabling an international Phase 1/2 trial—a signal of growing global clinical research collaboration in eye disease. Ophthalmology Times

📡 Broader Context on Global Trial Equity

Beyond ophthalmology, global clinical trial landscapes are showing persistent disparities that have implications for equity and research relevance:

Current guidance from the WHO calls for more effective and equitable clinical trials, emphasizing the need for inclusive participant diversity and better global infrastructure to support research in LMICs. World Health Organization

✔ An analysis of global ophthalmological trials found that over 84 % of participants come from high-income countries, with very limited representation from low-income regions—challenging the generalizability of outcomes to the populations that often bear the highest disease burden. bmjophth.bmj.com

✔ Reports on clinical trial access highlight that less than half of trials include any LMIC participation, and access to treatments post-approval lags significantly in regions where trials did occur, spotlighting ethical and access gaps.

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