Phosphodiesterase Inhibitors in Glaucoma Study (PhiGS)

NCT04052269 · Status: SUSPENDED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-01-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Sildenafil 100mg

study drug (Sildenafil or Tadalafil) administered orally in pill form with glass of water.

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Eduardo Dr Normando, MD, PhD · Imperial College London

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04052269 on ClinicalTrials.gov