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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BCN Peptides
ClinicalTrials.gov Identifier:
NCT01726075
First received: November 7, 2012
Last updated: January 11, 2016
Last verified: January 2016
  Purpose
To assess whether neuroprotective drugs administered topically (somatostatin and brimonidine) are able to prevent or arrest the development and progression of neurodegenerative changes

Condition Intervention Phase
Diabetic Retinopathy Drug: COLIRIOBCN070660 Drug: Placebo Drug: Brimonidine Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by BCN Peptides:

Primary Outcome Measures:
  • Changes in the Implicit Time assessed by mfERG (IT-mfERG) at month 6, 12, 18 and 24 [ Time Frame: month 24 ]

Secondary Outcome Measures:
  • 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 ]
  • Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at baseline [ Time Frame: baseline ]
  • Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 6 [ Time Frame: month 6 ]
  • Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 12 [ Time Frame: month 12 ]
  • Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 18 [ Time Frame: month 18 ]
  • Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 24 [ Time Frame: month 24 ]
  • Retinal thickness assessed by SD-OCT at month 0 [ Time Frame: month 0 ]
  • Retinal thickness assessed by SD-OCT at month 6 [ Time Frame: month 6 ]
  • Retinal thickness assessed by SD-OCT at month 12 [ Time Frame: month 12 ]
  • Retinal thickness assessed by SD-OCT at month 18 [ Time Frame: month 18 ]
  • Retinal thickness assessed by SD-OCT at month 24 [ Time Frame: month 24 ]
  • Central retinal thickness assessed by SD-OCT at month 0 [ Time Frame: month 0 ]
  • Central retinal thickness assessed by SD-OCT at month 6 [ Time Frame: month 6 ]
  • Central retinal thickness assessed by SD-OCT at month 12 [ Time Frame: month 12 ]
  • Central retinal thickness assessed by SD-OCT at month 18 [ Time Frame: month 18 ]
  • Central retinal thickness assessed by SD-OCT at month 24 [ Time Frame: month 24 ]
  • Diabetic Retinopathy (DR) severity assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) scale CFP - 30º/35º-7 fields at baseline [ Time Frame: baseline ]
  • DR severity assessed by ETDRS scale CFP - 30º/35º-7 fields at month 24 [ Time Frame: month 24 ]

Other Outcome Measures:
  • Best Corrected Visual Acuity (BCVA) assessed by ETDRS scale at month 0 [ Time Frame: month 0 ]
  • BCVA assessed by ETDRS scale at month 6 [ Time Frame: month 6 ]
  • BCVA assessed by ETDRS scale at month 12 [ Time Frame: month 12 ]
  • BCVA assessed by ETDRS scale at month 18 [ Time Frame: month 18 ]
  • BCVA assessed by ETDRS scale at month 24 [ Time Frame: month 24 ]
  • Visual Fields defects assessed by Visual Fields Test at month 0 [ Time Frame: month 0 ]
  • Visual Fields defects assessed by Visual Fields Test at month 24 [ Time Frame: month 24 ]
  • Visual health assessed by Visual Function Questionnaire (VFQ-25) at month 0 [ Time Frame: month 0 ]
  • Visual health assessed by Visual Function Questionnaire (VFQ-25) at month 24 [ Time Frame: month 24 ]
  • Adverse Events assessed by inquiry at month 0 [ Time Frame: month 0 ]
  • Adverse Events assessed by inquiry at month 3 [ Time Frame: month 3 ]
  • Adverse Events assessed by inquiry at month 6 [ Time Frame: month 6 ]
  • Adverse Events assessed by inquiry at month 12 [ Time Frame: month 12 ]
  • Adverse Events assessed by inquiry at month 18 [ Time Frame: month 18 ]
  • Adverse Events assessed by inquiry at month 24 [ Time Frame: month 24 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Enrollment: 450
Study Start Date: February 2013
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: COLIRIOBCN070660
COLIRIOBCN070660 Somatostatin 1mg/mL Eye drops, solution. One drop/eye administered twice a day.
Drug: COLIRIOBCN070660
One drop per eye twice a day during 24 months
Other Name: Somatostatin eye drops
Placebo Comparator: Placebo
Placebo Eye drops, solution. One drop/eye administered twice a day.
Drug: Placebo
One drop per eye twice a day during 24 months
Other Name: placebo eye drops
Experimental: Brimonidine
Brimonidine tartrate 2mg/mL One drop/eye administered twice a day.
Drug: Brimonidine
One drop per eye twice a day during 24 months
Other Name: Brimonidine eye drops

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.
  Eligibility

Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 < 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726075

Locations
Denmark
Syddansk Universitet (SDU)
Odense, Denmark
France
AP - Hopitaux de Paris (AP-HP)
Paris, France, 75010
Germany
Universitaet Ulm (UUlm)
Ulm, Germany, 89081
Italy
Universita Vita-Salute San Raffaele (USR)
Milano, Italy, 20132
Universita degli Study di Padova(UPadova)
Padova, Italy, 35128
Portugal
Aibili - Cec
Coimbra, Portugal, 3000-548
Spain
Institut Catala de la Salut - Hospital Universitari Vall d'Hebron (ICS-HUVH)
Barcelona, Spain, 08035
United Kingdom
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
Sponsors and Collaborators
BCN Peptides
Investigators
Principal Investigator: José Cunha-Vaz, Prof. Association for Innovation and Biomedical Research on Light and Image
  More Information

Responsible Party: BCN Peptides
ClinicalTrials.gov Identifier: NCT01726075     History of Changes
Other Study ID Numbers: 4C-2011-02
2012-001200-38 ( EudraCT Number )
Study First Received: November 7, 2012
Last Updated: January 11, 2016

Keywords provided by BCN Peptides:
diabetic retinopathy

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Ophthalmic Solutions
Tetrahydrozoline
Brimonidine Tartrate
Somatostatin
Neuroprotective Agents
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones

ClinicalTrials.gov processed this record on July 25, 2017