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Clinical trialNCT05581498WithdrawnInterventional

Glaucoma Exercise as Medicine Study (GEMS).

SponsorJohns Hopkins UniversityEnrollment0Glaucoma
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Project Summary Abstract: While lifestyle changes, particularly exercise, have been suggested to protect against damage to ganglion cells in animal models, definitive evidence demonstrating its benefits in humans is lacking. Here, in a group of individuals with ganglion cell damage from glaucoma and a separate control group without significant eye disease, the investigators study the effects of a remotely delivered exercise training program by a trained exercise physiologist consisting of resistance training combined with cycling on a stationary bike. Three outcomes will be examined to evaluate if exercise might be of potential long-term benefit in protecting ganglion cells. In Aim 1, the investigators will examine the trial's primary outcome, a comparison of the pointwise change in the visual field (VF) sensitivity over the exercise period compared to a preceding usual activity period. Given the subjective nature of VF testing, Electroretinogram (ERG) testing will be employed as a more objective secondary outcome. Together, these outcomes will determine if neuro recovery is possible with exercise in individuals with GC damage from glaucoma (as has been demonstrated for Intraocular pressure (IOP)-lowering and, more recently, nicotinamide) and if neuro enhancement (improvement in the function above an already-normal level) is possible in adults without eye disease. In Aim 2, the investigators will examine if an exercise produces physiologic changes in the human eye (glaucoma and control), which would give mechanistic plausibility for a neuroprotective effect. Specifically, the investigators will compare exercise-induced changes in large vessel retinal blood flow, the density of and flux within perfused capillaries, large-vessel arterial-venous oxygen (O2) saturation gradients, inner retinal O2 metabolism, and serum levels of brain-derived neurotrophic factor (BDNF) to changes occurring in the preceding usual activity control period. Finally, in Aim 3, the investigators will examine if exercise benefits quality of life (QOL) in individuals with VF damage from glaucoma within specific domains (mobility, ocular discomfort, and mood) independent of changes in visual function. Together, these findings will provide important information regarding whether exercise produces short-term changes in eyes, which suggests possible long-term protection against ganglion cell damage.

Investigators

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Sites

No facility list is in our current data snapshot for this study. The registry record on ClinicalTrials.gov ↗ carries any published locations. Why? →

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Jun 2026
Primary completion
31 Dec 2028
Completion
31 Dec 2028
Last update posted
5 Aug 2026
Registered enrollment
0
Registry id
NCT05581498

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.