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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
BCN Peptides
ClinicalTrials.gov Identifier:
NCT01726075
First received: November 7, 2012
Last updated: November 19, 2013
Last verified: November 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 0 [ Time Frame: month 0 ] [ Designated as safety issue: No ]
  • Changes in the Implicit Time assessed by mfERG (IT-mfERG)at month 6 [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • Changes in the Implicit Time assessed by mfERG (IT-mfERG)at month 12 [ Time Frame: month 12 ] [ Designated as safety issue: No ]
  • Changes in the Implicit Time assessed by mfERG (IT-mfERG)at month 18 [ Time Frame: month 18 ] [ Designated as safety issue: No ]
  • Changes in the Implicit Time assessed by mfERG (IT-mfERG)at month 24 [ Time Frame: month 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Retinal Nerve Fiber Layer (RNFL) assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) at month 0 [ Time Frame: month 0 ] [ Designated as safety issue: Yes ]
  • Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 6 [ Time Frame: month 6 ] [ Designated as safety issue: Yes ]
  • Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 12 [ Time Frame: month 12 ] [ Designated as safety issue: Yes ]
  • Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 18 [ Time Frame: month 18 ] [ Designated as safety issue: Yes ]
  • Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 24 [ Time Frame: month 24 ] [ Designated as safety issue: Yes ]
  • Ganglion Cell Layer (GCL) assessed by SD-OCT at month 0 [ Time Frame: month 0 ] [ Designated as safety issue: Yes ]
  • Ganglion Cell Layer (GCL) assessed by SD-OCT at month 6 [ Time Frame: month 6 ] [ Designated as safety issue: Yes ]
  • Ganglion Cell Layer (GCL) assessed by SD-OCT at month 12 [ Time Frame: month 12 ] [ Designated as safety issue: Yes ]
  • Ganglion Cell Layer (GCL) assessed by SD-OCT at month 18 [ Time Frame: month 18 ] [ Designated as safety issue: Yes ]
  • Ganglion Cell Layer (GCL) assessed by SD-OCT at month 24 [ Time Frame: month 24 ] [ Designated as safety issue: Yes ]
  • Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at baseline [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
  • Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 6 [ Time Frame: month 6 ] [ Designated as safety issue: Yes ]
  • Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 12 [ Time Frame: month 12 ] [ Designated as safety issue: Yes ]
  • Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 18 [ Time Frame: month 18 ] [ Designated as safety issue: Yes ]
  • Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 24 [ Time Frame: month 24 ] [ Designated as safety issue: Yes ]
  • Retinal thickness assessed by SD-OCT at month 0 [ Time Frame: month 0 ] [ Designated as safety issue: Yes ]
  • Retinal thickness assessed by SD-OCT at month 6 [ Time Frame: month 6 ] [ Designated as safety issue: Yes ]
  • Retinal thickness assessed by SD-OCT at month 12 [ Time Frame: month 12 ] [ Designated as safety issue: Yes ]
  • Retinal thickness assessed by SD-OCT at month 18 [ Time Frame: month 18 ] [ Designated as safety issue: Yes ]
  • Retinal thickness assessed by SD-OCT at month 24 [ Time Frame: month 24 ] [ Designated as safety issue: Yes ]
  • Central retinal thickness assessed by SD-OCT at month 0 [ Time Frame: month 0 ] [ Designated as safety issue: Yes ]
  • Central retinal thickness assessed by SD-OCT at month 6 [ Time Frame: month 6 ] [ Designated as safety issue: Yes ]
  • Central retinal thickness assessed by SD-OCT at month 12 [ Time Frame: month 12 ] [ Designated as safety issue: Yes ]
  • Central retinal thickness assessed by SD-OCT at month 18 [ Time Frame: month 18 ] [ Designated as safety issue: Yes ]
  • Central retinal thickness assessed by SD-OCT at month 24 [ Time Frame: month 24 ] [ Designated as safety issue: Yes ]
  • Diabetic Retinopathy (DR) severity assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) scale CFP - 30º/35º-7 fields at baseline [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
  • DR severity assessed by ETDRS scale CFP - 30º/35º-7 fields at month 24 [ Time Frame: month 24 ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Best Corrected Visual Acuity (BCVA) assessed by ETDRS scale at month 0 [ Time Frame: month 0 ] [ Designated as safety issue: Yes ]
  • BCVA assessed by ETDRS scale at month 6 [ Time Frame: month 6 ] [ Designated as safety issue: Yes ]
  • BCVA assessed by ETDRS scale at month 12 [ Time Frame: month 12 ] [ Designated as safety issue: Yes ]
  • BCVA assessed by ETDRS scale at month 18 [ Time Frame: month 18 ] [ Designated as safety issue: Yes ]
  • BCVA assessed by ETDRS scale at month 24 [ Time Frame: month 24 ] [ Designated as safety issue: Yes ]
  • Visual Fields defects assessed by Visual Fields Test at month 0 [ Time Frame: month 0 ] [ Designated as safety issue: Yes ]
  • Visual Fields defects assessed by Visual Fields Test at month 24 [ Time Frame: month 24 ] [ Designated as safety issue: Yes ]
  • Visual health assessed by Visual Function Questionnaire (VFQ-25) at month 0 [ Time Frame: month 0 ] [ Designated as safety issue: No ]
  • Visual health assessed by Visual Function Questionnaire (VFQ-25) at month 24 [ Time Frame: month 24 ] [ Designated as safety issue: No ]
  • Adverse Events assessed by inquiry at month 0 [ Time Frame: month 0 ] [ Designated as safety issue: Yes ]
  • Adverse Events assessed by inquiry at month 3 [ Time Frame: month 3 ] [ Designated as safety issue: Yes ]
  • Adverse Events assessed by inquiry at month 6 [ Time Frame: month 6 ] [ Designated as safety issue: Yes ]
  • Adverse Events assessed by inquiry at month 12 [ Time Frame: month 12 ] [ Designated as safety issue: Yes ]
  • Adverse Events assessed by inquiry at month 18 [ Time Frame: month 18 ] [ Designated as safety issue: Yes ]
  • Adverse Events assessed by inquiry at month 24 [ Time Frame: month 24 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 450
Study Start Date: February 2013
Estimated Primary Completion Date: March 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
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
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

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: BCN Peptides
ClinicalTrials.gov Identifier: NCT01726075     History of Changes
Other Study ID Numbers: 4C-2011-02, 2012-001200-38
Study First Received: November 7, 2012
Last Updated: November 19, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comité Ético de Investigación Clínica
France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes
Denmark: Danish Health and Medicines Authority
Denmark: Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
Portugal: Ethics Committee for Clinical Research
Germany: Ministry of Health
Italy: Ethics Committee

Keywords provided by BCN Peptides:
diabetic retinopathy

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Brimonidine
Neuroprotective Agents
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protective Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2014