Neurodegeneration as an early event in the pathogenesis of Diabetic Retinopathy: A multicentric, prospective, phase II-III, randomized controlled trial to assess the efficacy of neuroprotective drugs administered topically to prevent or arrest Diabetic Retinopathy.

Neurodegeneration as an early event in the pathogenesis of Diabetic Retinopathy: A multicentric, prospective, phase II-III, randomized controlled trial to assess the efficacy of neuroprotective drugs administered topically to prevent or arrest Diabetic Retinopathy. - EUROCONDOR

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001200-38-DE

Enrollment

450

Registered

2012-09-03

Start date

2012-09-07

Completion date

Unknown

Last updated

2015-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of neurodegeneration which occurs in Diabetic Retinopathy MedDRA version: 15.1 Level: PT Classification code 10012689 Term: Diabetic retinopathy System Organ Class: 10015919 - Eye disorders

Interventions

Product Name: COLIRIOBCN070660 Pharmaceutical Form: Eye drops, solution INN or Proposed INN: SOMATOSTATIN CAS Number: 38916-34-6 Current Sponsor code: S Other descriptive name: SOMATOSTATIN, SST Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with type 2 diabetes mellitus 2. Diabetes duration = 5 years 3. Aged between 45-75 years-old 4.ETDRS level =65 years) yes F.1.3.1 Number of subjects for this age range 450

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess whether neuroprotective drugs administered topically (somatostatin and brimonidine) are able to prevent or arrest the development and progression of neurodegenerative changes ;Secondary Objective: ?To determine the prevalence of functional and structural abnormalities related to neurodegeneration in those patients with or without detectable microvascular damage. ?To identify those patients most prone to progressive worsening of the retinopathy by identifying progression of DR using the ETDRS severity scale, BCVA, microvascular disease activity (MA turnover and retinal thickness) and neurodegenerative changes. ?To assess the correlation between the presence and progression of neuronal and glial alterations (mfERG abnormalities and ganglion cell layer thickness) and the appearance and progression of the microvascular lesions (MA turnover and overall retinal thickness). ?To assess whether there is an effect on the visual-related quality of life in the early stages of nonproliferative DR as measured by the VFQ-25. ?To evaluate the local and systemic adverse events of the selected drugs. ;Primary end point(s): Changes in the Implicit Time assessed by mfERG (IT-mfERG);Timepoint(s) of evaluation of this end point: month 0, month 6, month 12, month 18, month 24	—

Measure

Time frame

Main Objective: To assess whether neuroprotective drugs administered topically (somatostatin and brimonidine) are able to prevent or arrest the development and progression of neurodegenerative changes ;Secondary Objective: ?To determine the prevalence of functional and structural abnormalities related to neurodegeneration in those patients with or without detectable microvascular damage. ?To identify those patients most prone to progressive worsening of the retinopathy by identifying progression of DR using the ETDRS severity scale, BCVA, microvascular disease activity (MA turnover and retinal thickness) and neurodegenerative changes. ?To assess the correlation between the presence and progression of neuronal and glial alterations (mfERG abnormalities and ganglion cell layer thickness) and the appearance and progression of the microvascular lesions (MA turnover and overall retinal thickness). ?To assess whether there is an effect on the visual-related quality of life in the early stages of nonproliferative DR as measured by the VFQ-25. ?To evaluate the local and systemic adverse events of the selected drugs. ;Primary end point(s): Changes in the Implicit Time assessed by mfERG (IT-mfERG);Timepoint(s) of evaluation of this end point: month 0, month 6, month 12, month 18, month 24

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Secondary

Measure	Time frame
Secondary end point(s): Neurodegenerative variables: ?Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT ?Ganglion Cell Layer (GCL) assessed by SD-OCT Microvascular variables: ?Microaneurysm turnover assessed by Colour Fundus Photography ?Retinal thickness assessed by SD-OCT ?Central retinal thickness assessed by SD-OCT ?DR severity assessed by ETDRS scale Other variables: ?BCVA assessed by ETDRS scale ?Visual Fields defects assessed by Visual Fields Test ?Visual health assessed by Visual Function Questionnaire (VFQ-25) ?Adverse Events assessed by inquiry and ophthalmological examination ;Timepoint(s) of evaluation of this end point: -Ophthalmological Examination: Screening, month 0, month 3, month 6, month 12, month 18, month 24 -VFQ-25 and VF:month 0, month 24 -CFP – 30º/35º-7 fields (for ETDRS grading): Screening, month 24 -CFP – 45º/50º Field 2 (for automated MA assessment): Screening, month 6, month 12, month 18, month 24 -SD-OCT, BCVA:month 0, month 6, month 12, month 18, month 24	—

Measure

Time frame

Secondary end point(s): Neurodegenerative variables: ?Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT ?Ganglion Cell Layer (GCL) assessed by SD-OCT Microvascular variables: ?Microaneurysm turnover assessed by Colour Fundus Photography ?Retinal thickness assessed by SD-OCT ?Central retinal thickness assessed by SD-OCT ?DR severity assessed by ETDRS scale Other variables: ?BCVA assessed by ETDRS scale ?Visual Fields defects assessed by Visual Fields Test ?Visual health assessed by Visual Function Questionnaire (VFQ-25) ?Adverse Events assessed by inquiry and ophthalmological examination ;Timepoint(s) of evaluation of this end point: -Ophthalmological Examination: Screening, month 0, month 3, month 6, month 12, month 18, month 24 -VFQ-25 and VF:month 0, month 24 -CFP – 30º/35º-7 fields (for ETDRS grading): Screening, month 24 -CFP – 45º/50º Field 2 (for automated MA assessment): Screening, month 6, month 12, month 18, month 24 -SD-OCT, BCVA:month 0, month 6, month 12, month 18, month 24

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Countries

Denmark, France, Germany, Italy, Portugal, Spain, United Kingdom

Contacts

Public ContactSabine Janssen

TFS Trial Form Support BV

sabine.janssen@tfscro.com31418760076

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026