Back to resultsTrial to Assess the Efficacy of Neuroprotective Drugs Administered Topically to Prevent or Arrest Diabetic Retinopathy (EUROCONDOR)
Primary Purpose
Diabetic Retinopathy
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
COLIRIOBCN070660
Placebo
Brimonidine
Sponsored by
About this trial
This is an interventional prevention trial for Diabetic Retinopathy focused on measuring diabetic retinopathy
Eligibility Criteria
Inclusion Criteria:
- 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.
- Informed Consent
Exclusion Criteria:
- 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)
Sites / Locations
- Syddansk Universitet (SDU)
- AP - Hopitaux de Paris (AP-HP)
- Universitaet Ulm (UUlm)
- Universita Vita-Salute San Raffaele (USR)
- Universita degli Study di Padova(UPadova)
- Aibili - Cec
- Institut Catala de la Salut - Hospital Universitari Vall d'Hebron (ICS-HUVH)
- Gloucestershire Hospitals NHS Foundation Trust (CHGH)
- Aston University (UAston)Heart of England NHS Foundation Trust
- The University of Liverpool (UOL)
- Moorfields Eye Hospital NHS Foundation Trust (MEH)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
COLIRIOBCN070660
Placebo
Brimonidine
Arm Description
COLIRIOBCN070660 Somatostatin 1mg/mL Eye drops, solution. One drop/eye administered twice a day.
Placebo Eye drops, solution. One drop/eye administered twice a day.
Brimonidine tartrate 2mg/mL One drop/eye administered twice a day.
Outcomes
Primary Outcome Measures
Changes in the Implicit Time assessed by mfERG (IT-mfERG) at month 6, 12, 18 and 24
Secondary Outcome Measures
Retinal Nerve Fiber Layer (RNFL) assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) at month 0
Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 6
Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 12
Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 18
Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 24
Ganglion Cell Layer (GCL) assessed by SD-OCT at month 0
Ganglion Cell Layer (GCL) assessed by SD-OCT at month 6
Ganglion Cell Layer (GCL) assessed by SD-OCT at month 12
Ganglion Cell Layer (GCL) assessed by SD-OCT at month 18
Ganglion Cell Layer (GCL) assessed by SD-OCT at month 24
Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at baseline
Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 6
Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 12
Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 18
Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 24
Retinal thickness assessed by SD-OCT at month 0
Retinal thickness assessed by SD-OCT at month 6
Retinal thickness assessed by SD-OCT at month 12
Retinal thickness assessed by SD-OCT at month 18
Retinal thickness assessed by SD-OCT at month 24
Central retinal thickness assessed by SD-OCT at month 0
Central retinal thickness assessed by SD-OCT at month 6
Central retinal thickness assessed by SD-OCT at month 12
Central retinal thickness assessed by SD-OCT at month 18
Central retinal thickness assessed by SD-OCT at month 24
Diabetic Retinopathy (DR) severity assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) scale CFP - 30º/35º-7 fields at baseline
DR severity assessed by ETDRS scale CFP - 30º/35º-7 fields at month 24
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01726075
Brief Title
Trial to Assess the Efficacy of Neuroprotective Drugs Administered Topically to Prevent or Arrest Diabetic Retinopathy
Acronym
EUROCONDOR
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BCN Peptides
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To assess whether neuroprotective drugs administered topically (somatostatin and brimonidine) are able to prevent or arrest the development and progression of neurodegenerative changes
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
diabetic retinopathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
450 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COLIRIOBCN070660
Arm Type
Experimental
Arm Description
COLIRIOBCN070660 Somatostatin 1mg/mL Eye drops, solution. One drop/eye administered twice a day.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Eye drops, solution. One drop/eye administered twice a day.
Arm Title
Brimonidine
Arm Type
Experimental
Arm Description
Brimonidine tartrate 2mg/mL One drop/eye administered twice a day.
Intervention Type
Drug
Intervention Name(s)
COLIRIOBCN070660
Other Intervention Name(s)
Somatostatin eye drops
Intervention Description
One drop per eye twice a day during 24 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
placebo eye drops
Intervention Description
One drop per eye twice a day during 24 months
Intervention Type
Drug
Intervention Name(s)
Brimonidine
Other Intervention Name(s)
Brimonidine eye drops
Intervention Description
One drop per eye twice a day during 24 months
Primary Outcome Measure Information:
Title
Changes in the Implicit Time assessed by mfERG (IT-mfERG) at month 6, 12, 18 and 24
Time Frame
month 24
Secondary Outcome Measure Information:
Title
Retinal Nerve Fiber Layer (RNFL) assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) at month 0
Time Frame
month 0
Title
Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 6
Time Frame
month 6
Title
Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 12
Time Frame
month 12
Title
Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 18
Time Frame
month 18
Title
Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 24
Time Frame
month 24
Title
Ganglion Cell Layer (GCL) assessed by SD-OCT at month 0
Time Frame
month 0
Title
Ganglion Cell Layer (GCL) assessed by SD-OCT at month 6
Time Frame
month 6
Title
Ganglion Cell Layer (GCL) assessed by SD-OCT at month 12
Time Frame
month 12
Title
Ganglion Cell Layer (GCL) assessed by SD-OCT at month 18
Time Frame
month 18
Title
Ganglion Cell Layer (GCL) assessed by SD-OCT at month 24
Time Frame
month 24
Title
Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at baseline
Time Frame
baseline
Title
Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 6
Time Frame
month 6
Title
Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 12
Time Frame
month 12
Title
Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 18
Time Frame
month 18
Title
Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 24
Time Frame
month 24
Title
Retinal thickness assessed by SD-OCT at month 0
Time Frame
month 0
Title
Retinal thickness assessed by SD-OCT at month 6
Time Frame
month 6
Title
Retinal thickness assessed by SD-OCT at month 12
Time Frame
month 12
Title
Retinal thickness assessed by SD-OCT at month 18
Time Frame
month 18
Title
Retinal thickness assessed by SD-OCT at month 24
Time Frame
month 24
Title
Central retinal thickness assessed by SD-OCT at month 0
Time Frame
month 0
Title
Central retinal thickness assessed by SD-OCT at month 6
Time Frame
month 6
Title
Central retinal thickness assessed by SD-OCT at month 12
Time Frame
month 12
Title
Central retinal thickness assessed by SD-OCT at month 18
Time Frame
month 18
Title
Central retinal thickness assessed by SD-OCT at month 24
Time Frame
month 24
Title
Diabetic Retinopathy (DR) severity assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) scale CFP - 30º/35º-7 fields at baseline
Time Frame
baseline
Title
DR severity assessed by ETDRS scale CFP - 30º/35º-7 fields at month 24
Time Frame
month 24
Other Pre-specified Outcome Measures:
Title
Best Corrected Visual Acuity (BCVA) assessed by ETDRS scale at month 0
Time Frame
month 0
Title
BCVA assessed by ETDRS scale at month 6
Time Frame
month 6
Title
BCVA assessed by ETDRS scale at month 12
Time Frame
month 12
Title
BCVA assessed by ETDRS scale at month 18
Time Frame
month 18
Title
BCVA assessed by ETDRS scale at month 24
Time Frame
month 24
Title
Visual Fields defects assessed by Visual Fields Test at month 0
Time Frame
month 0
Title
Visual Fields defects assessed by Visual Fields Test at month 24
Time Frame
month 24
Title
Visual health assessed by Visual Function Questionnaire (VFQ-25) at month 0
Time Frame
month 0
Title
Visual health assessed by Visual Function Questionnaire (VFQ-25) at month 24
Time Frame
month 24
Title
Adverse Events assessed by inquiry at month 0
Time Frame
month 0
Title
Adverse Events assessed by inquiry at month 3
Time Frame
month 3
Title
Adverse Events assessed by inquiry at month 6
Time Frame
month 6
Title
Adverse Events assessed by inquiry at month 12
Time Frame
month 12
Title
Adverse Events assessed by inquiry at month 18
Time Frame
month 18
Title
Adverse Events assessed by inquiry at month 24
Time Frame
month 24
Title
ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 0
Time Frame
month 0
Title
ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 3
Time Frame
month 3
Title
ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 6
Time Frame
month 6
Title
ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 12
Time Frame
month 12
Title
ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 18
Time Frame
month 18
Title
ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 24
Time Frame
month 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Informed Consent
Exclusion Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Cunha-Vaz, Prof.
Organizational Affiliation
Association for Innovation and Biomedical Research on Light and Image
Official's Role
Principal Investigator
Facility Information:
Facility Name
Syddansk Universitet (SDU)
City
Odense
Country
Denmark
Facility Name
AP - Hopitaux de Paris (AP-HP)
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Universitaet Ulm (UUlm)
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Universita Vita-Salute San Raffaele (USR)
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Universita degli Study di Padova(UPadova)
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Aibili - Cec
City
Coimbra
ZIP/Postal Code
3000-548
Country
Portugal
Facility Name
Institut Catala de la Salut - Hospital Universitari Vall d'Hebron (ICS-HUVH)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Gloucestershire Hospitals NHS Foundation Trust (CHGH)
City
Cheltenham
State/Province
Gloucestershire
Country
United Kingdom
Facility Name
Aston University (UAston)Heart of England NHS Foundation Trust
City
Birmingham
Country
United Kingdom
Facility Name
The University of Liverpool (UOL)
City
Liverpool
Country
United Kingdom
Facility Name
Moorfields Eye Hospital NHS Foundation Trust (MEH)
City
London
ZIP/Postal Code
EC1V2PD
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
28785768
Citation
Cunha-Vaz J, Ribeiro L, Costa M, Simo R. Diabetic Retinopathy Phenotypes of Progression to Macular Edema: Pooled Analysis From Independent Longitudinal Studies of up to 2 Years' Duration. Invest Ophthalmol Vis Sci. 2017 May 1;58(6):BIO206-BIO210. doi: 10.1167/iovs.17-21780.
Results Reference
derived
PubMed Identifier
28663190
Citation
Santos AR, Ribeiro L, Bandello F, Lattanzio R, Egan C, Frydkjaer-Olsen U, Garcia-Arumi J, Gibson J, Grauslund J, Harding SP, Lang GE, Massin P, Midena E, Scanlon P, Aldington SJ, Simao S, Schwartz C, Ponsati B, Porta M, Costa MA, Hernandez C, Cunha-Vaz J, Simo R; European Consortium for the Early Treatment of Diabetic Retinopathy (EUROCONDOR). Functional and Structural Findings of Neurodegeneration in Early Stages of Diabetic Retinopathy: Cross-sectional Analyses of Baseline Data of the EUROCONDOR Project. Diabetes. 2017 Sep;66(9):2503-2510. doi: 10.2337/db16-1453. Epub 2017 Jun 29.
Results Reference
derived
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Trial to Assess the Efficacy of Neuroprotective Drugs Administered Topically to Prevent or Arrest Diabetic Retinopathy
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