To assess whether neuroprotective drugs administered topically (somatostatin and brimonidine)
are able to prevent or arrest the development and progression of neurodegenerative changes
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Locations near you
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Full eligibility criteria for NCT01726075
Ages eligible for Study
45 Years to 75 Years
Genders eligible for Study
Accepts Healthy Volunteers
Patients with type 2 diabetes mellitus
Diabetes duration ≥ 5 years
Aged between 45-75 years-old
ETDRS level < 20 (microaneurysms absent) (50% of enrolled patients) Or ETDRS levels 20 or 35 with presence of at least one microaneurysm in Field 2 between the superior and inferior arcades (50% of enrolled patients) in the Study Eye as determined by the Reading Centre.
Previous laser photocoagulation
Other diseases which may induce retinal degeneration (e.g. glaucoma)
Subject with a refractive error ≥ ± 5 diopter
Inadequate ocular media and/ or pupil dilatation that do not permit good quality fundus photography.
Renal failure (creatinine > 1.4 mg/dl)
HbA1C > 10 % in the previous 6 months and at Screening
Subjects taking somatostatin or brimonidine, for any indication, in the previous 3 months
Subject has a condition or is in a situation which may put the subject at significant risk, may confound the study results or may interfere significantly with the patient's participation in the study.
Pregnancy or nursing
Hypersensitivity to the active substances to be tested or to any of the excipients
Subject receiving systemic monoamine oxidase (MAO) inhibitor therapy or antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin)
All locations for NCT01726075
Syddansk Universitet (SDU)
AP - Hopitaux de Paris (AP-HP)
Paris, France, 75010
Universitaet Ulm (UUlm)
Ulm, Germany, 89081
Universita Vita-Salute San Raffaele (USR)
Milano, Italy, 20132
Universita degli Study di Padova(UPadova)
Padova, Italy, 35128
Aibili - Cec
Coimbra, Portugal, 3000-548
Institut Catala de la Salut - Hospital Universitari Vall d'Hebron (ICS-HUVH)
Barcelona, Spain, 08035
United Kingdom (4)
Gloucestershire Hospitals NHS Foundation Trust (CHGH)
Cheltenham, Gloucestershire, United Kingdom
Aston University (UAston)Heart of England NHS Foundation Trust
Birmingham, United Kingdom
The University of Liverpool (UOL)
Liverpool, United Kingdom
Moorfields Eye Hospital NHS Foundation Trust (MEH)
London, United Kingdom, EC1V2PD
View full eligibility
Tris trial is registered with FDA with number: NCT01726075. The sponsor of the trial is BCN Peptides and it is looking for 450 volunteers for the current phase.
Official trial title: Neurodegeneration as Early Event in Pathogenesis of Diabetic Retinopathy:Multicentric, Prospective, Ph. II-III,Random.Controlled Trial to Assess Efficacy of Neuroprotective Drugs Administered Topically to Prevent/Arrest Diabetic Retinopathy
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