Clinical Research Directory

Study Evaluating the Efficacy and Safety of Chloroprocaine HCl Ophthalmic Gel 3% vs Proparacaine Ophthalmic Solution 0.5% Plus Subconjunctival Lidocaine in Patients Undergoing Intravitreal Injections

This Phase 4, multicenter, randomized, double-masked clinical study evaluates the efficacy and safety of chloroprocaine hydrochloride ophthalmic gel 3% (IHEEZO) compared with routine anesthesia (topical proparacaine 0.5% combined with subconjunctival lidocaine 2%) for ocular surface anesthesia during intravitreal injection procedures. Adult participants scheduled to undergo unilateral intravitreal injection of an FDA-approved anti-vascular endothelial growth factor (anti-VEGF) agent for retinal conditions will be randomized in a 1:1 ratio to receive either IHEEZO with a sham subconjunctival procedure or routine anesthesia. The primary objective is to determine whether IHEEZO is non-inferior to routine anesthesia in achieving successful ocular surface anesthesia, defined as a participant-reported pain score of 0 or 1 (on a 0-5 ordinal pain scale) immediately before and immediately after intravitreal injection. Secondary outcomes include individual and cumulative pain scores, change from baseline in dry eye symptoms measured by the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire, and ocular safety assessments through Day 7 follow-up.

Proteomic Biomarker Identification in AMD, Diabetic Retinopathy and Retinal Detachment

This prospective interventional translational study aims to identify and validate protein biomarkers associated with major ophthalmological diseases, including age-related macular degeneration (AMD), diabetic retinopathy (DR), and retinal detachment (RD). A total of approximately 260 participants (cases and controls) will be enrolled at a single center. Biological samples, including peripheral blood, tears, aqueous humor, vitreous humor, and subretinal fluid, will be collected during routine clinical and surgical procedures. Advanced clinical proteomics approaches will be applied to characterize molecular signatures associated with disease onset, progression, and response to treatment. The study seeks to improve the understanding of disease pathophysiology and support the development of novel diagnostic and prognostic biomarkers in ophthalmology.

EarLy Treatment Response in nEoVascular Macular Degeneration With Eylea 8mg: ELEV8 A Prospective Observational Open Label Study Investigating the Fluid Dynamics During Early Response to Aflibercept 8mg in Patients With Exudative Age-related Macular Degeneration (AMD).

This prospective, observational, open-label study evaluates early treatment response to intravitreal aflibercept 8 mg in patients with exudative age-related macular degeneration. Retinal fluid dynamics assessed by optical coherence tomography and changes in best-corrected visual acuity two months after baseline are analyzed to characterize early treatment outcomes.

High-throughput Large-model-based AI-assisted Diagnosis Using OCT

This observational study aims to establish key technologies for high-throughput, large-model-based AI-assisted diagnosis using optical coherence tomography (OCT) and OCT angiography (OCTA). The study will collect real-world OCT/OCTA images and corresponding clinical information from patients with common blinding retinal and optic nerve diseases at Peking Union Medical College Hospital. A high-throughput diagnostic framework based on large-scale artificial intelligence models will be developed and evaluated. The primary objective is to determine the diagnostic performance of the AI system, including its ability to identify diabetic retinopathy, branch retinal vein occlusion, central retinal vein occlusion, age-related macular degeneration, pathologic myopic choroidal neovascularization, and glaucoma-related optic nerve damage. The results of this study are expected to support the development of standardized, efficient, and scalable AI-assisted diagnostic pathways for OCT imaging in clinical practice.

Artificial Intelligence-Aided Screening for Patients With Diabetic Retinopathy and Age-related Macular Degeneration in Family Medicine and Geriatric Medicine Outpatient Clinics

Diabetic retinopathy (DR) and age-related macular degeneration (AMD) are leading causes of vision loss, with rising incidence due to aging populations and increasing diabetes prevalence. However, delayed diagnoses are common due to low disease literacy and lack of dedicated screening tools in internal medicine. This multi-center RCT at National Taiwan University Hospital evaluates the clinical effectiveness and cost-effectiveness of the VeriSee AI-assisted diagnostic software for DR and AMD screening. Participants include adults with diabetes and individuals aged 50 and above meeting AMD screening criteria, randomized to AI-assisted screening with immediate physician explanation or standard physician-only screening. Primary outcomes include detection rates of DR and AMD, ophthalmology referral outcomes, and patient/physician satisfaction. Data collection will occur from April 2025 to December 2027. This study aims to provide evidence on the clinical utility of AI-assisted ophthalmic screening in improving early detection, facilitating timely treatment, and reducing severe visual impairment and healthcare burdens in real-world clinical settings.

Effectiveness and Cost-Effectiveness Evaluations of AI-Assisted Diagnostic Software (VeriSee) for Ophthalmic Disease Screening

This study aims to evaluate the effectiveness of an artificial intelligence (AI)-assisted screening system in ophthalmic diagnosis. Using AI-based fundus photography, the system will assist physicians in diagnosing three common eye diseases: age-related macular degeneration and diabetic retinopathy (DR). The AI system will analyze fundus images from participants and rapidly generate detection results for ophthalmologists' reference in making final diagnoses and clinical decisions. The study will assess the clinical benefits of the AI-assisted diagnostic system, providing scientific evidence to enhance the efficiency of ophthalmic disease diagnosis and treatment.

Study of JMKX003948 Ophthalmic Suspension in Healthy Participants

The study is a randomized, double-blind, placebo-controlled, phase 1 study of JMKX003948 Ophthalmic Suspension to evaluate the safety, tolerability and PK of single and multiple ascending doses in healthy participants. Participant will be randomized to receive either JMKX003948 Ophthalmic Suspension (1%, 2%, 3% or 5%) or matching placebo (JMKX003948 Ophthalmic Suspension: placebo= 6: 2, N=8 per cohort). Five cohorts (Cohort 1-5) are planned. Cohorts could also de-escalate to a lower concentration if current formulation was not tolerated (Cohort 1b, 2b and 3b). In case of de-escalation, Cohort 1b and 2b will continue to escalate to Cohort 1c and Cohort 2c, respectively. Participants will be admitted to the site on Day -1 after screening (up to 28 days), and remain domiciled until Day 14 for Cohort 1-4, Day 8 for other cohorts.