Abstract
Purpose: To investigate the trends and progresses in glaucoma research by searching two major clinical trial registries; clinicaltrials.gov, and Australianclinicaltrials.gov.au.Methods: All clinical trials with glaucoma covered by Clinicaltrials.gov, and Australianclinicaltrials.gov.au starting the study before 1 January 2021 were included. Trials evaluating glaucoma treatment were separated from non-treatment trials and divided into three major categories: “laser treatment,” “surgical treatment,” and “medical treatment.” In the category of “medical treatment,” new compounds and their individual targets were identified and subcategorized according to treatment strategy; intraocular pressure (IOP)-lowering, neuroprotective or vascular. The phase transition success rates were calculated.Results: One-thousand five hundred and thirty-seven trials were identified. Sixty-three percent (n = 971) evaluated glaucoma treatment, of which medical treatment accounted for the largest proportion (53%). The majority of medical trials evaluated IOP-lowering compounds, while trials with neuroprotective or vascular compounds accounted for only 5 and 3%, respectively. Eighty-eight new compounds were identified. Phase I, II, and III transition success rates were 63, 26, and 47%, respectively.Conclusion: The number of clinical trials in glaucoma research has increased significantly over the last 30 years. Among the most recently evaluated compounds, all three main treatment strategies were represented, but clinical trials in neuroprotection and vascular modalities are still sparse. In addition to traditional medicines, dietary supplements and growth factors are assessed for a potential anti-glaucomatous effect. Phase II and III success rates were below previously reported success rates for all diseases and ophthalmology in general. A stricter phenotyping of patients can improve the success rates in glaucoma and ophthalmological research and gain a better understanding of responders and non-responders.
Highlights
Glaucoma is one of the leading causes of global irreversible blindness, and the prevalence is increasing [1, 2]
The objective of this paper is to provide an overview of the different types of glaucoma treatments and to investigate whether the strategies and targets in glaucoma drug development have changed over time
One-thousand five hundred and twenty-three trials were identified in the ClinicalTrials database, and in addition, 14 trials were identified in the Australian Clinical Database
Summary
Glaucoma is one of the leading causes of global irreversible blindness, and the prevalence is increasing [1, 2]. Glaucoma is characterized by a progressive degeneration of the optic nerve with corresponding visual field loss and blindness if left untreated. The pathophysiology of glaucoma is multifactorial and there are several clinical phenotypes [3]. Glaucoma can be divided into primary glaucoma, secondary glaucoma and the rarer forms of juvenile and congenital glaucoma. There are two clinical phenotypes, open-angle glaucoma (POAG) and angle-closure glaucoma. In all glaucoma subtypes, elevated intraocular pressure (IOP) is recognized as a major risk factor for the development and progression of glaucoma and lowering IOP is currently the only documented method of treating glaucoma
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