Trial to Assess the Efficacy of Neuroprotective Drugs Administered Topically to Prevent or Arrest Diabetic Retinopathy

BCN Peptides450 enrolled

Overview

To assess whether neuroprotective drugs administered topically (somatostatin and brimonidine) are able to prevent or arrest the development and progression of neurodegenerative changes

To assess whether neuroprotective drugs administered topically (somatostatin and brimonidine) are able to prevent or arrest the development and progression of neurodegenerative changes related to diabetic retinopathy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

450

Conditions

Diabetic Retinopathy

Interventions

COLIRIOBCN070660DRUG

One drop per eye twice a day during 24 months

PlaceboDRUG

One drop per eye twice a day during 24 months

BrimonidineDRUG

One drop per eye twice a day during 24 months

Eligibility

Sex: ALLMin age: 45 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with type 2 diabetes mellitus 2. Diabetes duration ≥ 5 years 3. Aged between 45-75 years-old 4. 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. 5. Informed Consent Exclusion Criteria: 1. Previous laser photocoagulation 2. Other diseases which may induce retinal degeneration (e.g. glaucoma) 3. Subject with a refractive error ≥ ± 5 diopter 4. Inadequate ocular media and/ or pupil dilatation that do not permit good quality fundus photography. 5. Renal failure (creatinine \> 1.4 mg/dl) 6. HbA1C \> 10 % in the previous 6 months and at Screening 7. Subjects taking somatostatin or brimonidine, for any indication, in the previous 3 months 8. 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. 9. Pregnancy or nursing 10. Hypersensitivity to the active substances to be tested or to any of the excipients 11. Subject receiving systemic monoamine oxidase (MAO) inhibitor therapy or antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin)

Locations (11)

Syddansk Universitet (SDU)

Odense, Denmark

AP - Hopitaux de Paris (AP-HP)

Paris, Paris, France

Universitaet Ulm (UUlm)

Ulm, Germany

Outcomes

Primary Outcomes

Changes in the Implicit Time assessed by mfERG (IT-mfERG) at month 6, 12, 18 and 24

Time frame: month 24

Secondary Outcomes

Retinal Nerve Fiber Layer (RNFL) assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) at month 0

Time frame: month 0

Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 6

Time frame: month 6

Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 12

Time frame: month 12

Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 18

Time frame: month 18

Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 24

Time frame: month 24

Ganglion Cell Layer (GCL) assessed by SD-OCT at month 0

Time frame: month 0

Ganglion Cell Layer (GCL) assessed by SD-OCT at month 6

Time frame: month 6

Ganglion Cell Layer (GCL) assessed by SD-OCT at month 12

Time frame: month 12

Ganglion Cell Layer (GCL) assessed by SD-OCT at month 18

Time frame: month 18

Ganglion Cell Layer (GCL) assessed by SD-OCT at month 24

Time frame: month 24

Data from ClinicalTrials.gov

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