drugset / Trial / NCT04052269

Phosphodiesterase Inhibitors in Glaucoma Study (PhiGS)

NCT04052269

Phase 3 Suspended 30 enrolled Imperial College London
Non-randomizedParallel-groupOpen-labelTreatment

Summary

It is commonly known that high eye pressure is associated with glaucoma. However, there is also a theory that poor circulation to the eye is a contributing factor. Therefore, if we can increase the flow of blood to the eye, we may be able to stop people losing vision from this disease. Phosphodiesterase inhibitors (for example sildenafil, tadalafil, Viagra®, Cialis®) are drugs used to improve blood flow to certain parts of the body. They are commonly used on an ad-hoc basis to treat erectile dysfunction, in addition to problems with blood circulation to the lungs, fingers and toes. The majority of previous work in this field has been completed using insensitive, poorly reproducible techniques such as colour doppler ultrasound. Since then, a new imaging modality able to image blood flow in blood vessels without the need for the injection of contrast has entered clinical use. This initial pilot study is designed as a proof-of-concept study to investigate whether we can measure detectable changes in the blood flow to the retina and choroid at the back of the eye following ingestion of a phosphodiesterase inhibitor medication by healthy and glaucomatous volunteers already taking this medication for erectile dysfunction.

Timeline

Start
2019-06-21
Primary completion
2021-10-30
Completion
2022-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Sildenafil Unknown 100 mg Oral
Subject Tadalafil Small molecule Oral

Indications