Trial to Assess the Efficacy of Neuroprotective Drugs Administered Topically to Prevent or Arrest Diabetic Retinopathy (EUROCONDOR)
This study is currently recruiting participants.
Verified March 2013 by BCN Peptides
Sponsor:
BCN Peptides
Information provided by (Responsible Party):
BCN Peptides
ClinicalTrials.gov Identifier:
NCT01726075
First received: November 7, 2012
Last updated: March 21, 2013
Last verified: March 2013
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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:
- 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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726075
Contacts
| Contact: Miguel Ângelo Costa | +351 239 480 142 | 4c@aibili.pt |
Locations
| Denmark | |
| Syddansk Universitet (SDU) | Recruiting |
| Odense, Denmark | |
| Principal Investigator: Jakob Grauslund, MD | |
| France | |
| AP - Hopitaux de Paris (AP-HP) | Recruiting |
| Paris, France, 75010 | |
| Principal Investigator: Pascale Massin, MD | |
| Germany | |
| Universitaet Ulm (UUlm) | Recruiting |
| Ulm, Germany, 89081 | |
| Principal Investigator: Gabriele Lang, MD | |
| Italy | |
| Universita Vita-Salute San Raffaele (USR) | Not yet recruiting |
| Milano, Italy, 20132 | |
| Principal Investigator: Francesco Bandello, MD | |
| Universita degli Study di Padova(UPadova) | Not yet recruiting |
| Padova, Italy, 35128 | |
| Principal Investigator: Edoardo Midena, MD | |
| Portugal | |
| Aibili - Cec | Recruiting |
| Coimbra, Portugal, 3000-548 | |
| Principal Investigator: Luisa Ribeino, MD | |
| Spain | |
| Institut Catala de la Salut - Hospital Universitari Vall d'Hebron (ICS-HUVH) | Recruiting |
| Barcelona, Spain, 08035 | |
| Principal Investigator: José García-Arumí, MD | |
| United Kingdom | |
| Gloucestershire Hospitals NHS Foundation Trust (CHGH) | Recruiting |
| Cheltenham, Gloucestershire, United Kingdom | |
| Principal Investigator: Peter Scanlon, MD | |
| Aston University (UAston)Heart of England NHS Foundation Trust | Recruiting |
| Birmingham, United Kingdom | |
| Principal Investigator: Jonathan Gibson, MD | |
| The University of Liverpool (UOL) | Not yet recruiting |
| Liverpool, United Kingdom | |
| Principal Investigator: Simon Harding, MD | |
| Moorfields Eye Hospital NHS Foundation Trust (MEH) | Recruiting |
| London, United Kingdom, EC1V2PD | |
| Principal Investigator: Cathy Egan, MD | |
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: | March 21, 2013 |
| Health Authority: | Spain: Agencia Española de Medicamentos y Productos Sanitarios Spain: Comité Ético de Investigación Clínica France: L’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 Adrenergic alpha-2 Receptor Agonists |
Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Protective Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 21, 2013