NCT02099981

Restoration of Retinal Vascular Responses in Type 1 Diabetic Patients

Completed Phase 1 Last updated 16 January 2018

What this trial tests

Phase 1 trial testing Aminoguanidine in Diabetic Retinopathy in 34 participants. Completed in 1 December 2017.

Timeline

1 July 2016

Primary endpoint
1 December 2017

1 December 2017

Quick facts

Lead sponsor	University of Minnesota
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	34
Start date	1 July 2016
Primary completion	1 December 2017
Estimated completion	1 December 2017
Sites	1 location across United States

Drugs / interventions tested

• Aminoguanidine — full drug profile →

Conditions studied

• Diabetic Retinopathy — all drugs for Diabetic Retinopathy →

Sponsor

University of Minnesota

Who can join

Adults 18 to 65, any sex, with Diabetic Retinopathy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The vascular response to flicker
  Time frame: 90 minutes
  The vascular response will be defined as the ratio of the maximal vessel diameter observed during the stimulation period, compared to the mean diameter during the control period

Sponsor's own description

Diabetic retinopathy is the leading cause of blindness in the developed world. The causes of the disease are poorly understood. One of the earliest changes that occur in the retinas of diabetic patients, well before overt retinopathy is observed, is a reduction in light-evoked increases in blood flow in retinal vessels. The loss of this vascular response may lead to retinal hypoxia and it has been suggested that hypoxia could be a principal cause of diabetic retinopathy.

The long-term goals of this project are to determine whether decreased blood flow in diabetic patients and the resulting retinal hypoxia contributes to the development of diabetic retinopathy and whether restoration of normal blood flow in diabetic patients slows or prevents the development of retinopathy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. PPARα Agonist Oral Therapy in Diabetic Retinopathy.
   Tomita Y, Lee D, Tsubota K, Kurihara T. · · 2020 · cited 34× · PMID 33086679 · DOI 10.3390/biomedicines8100433