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

Sponsor
BCN Peptides (Industry)
Overall Status
Completed
CT.gov ID
NCT01726075
Collaborator
(none)
450
Enrollment
11
Locations
3
Arms
33
Duration (Months)
40.9
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
450 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (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
Study Start Date :
Feb 1, 2013
Actual Primary Completion Date :
Nov 1, 2015
Actual Study Completion Date :
Nov 1, 2015

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • Brimonidine eye drops

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in the Implicit Time assessed by mfERG (IT-mfERG) at month 6, 12, 18 and 24 [month 24]

    Secondary Outcome Measures

    1. Retinal Nerve Fiber Layer (RNFL) assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) at month 0 [month 0]

    2. Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 6 [month 6]

    3. Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 12 [month 12]

    4. Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 18 [month 18]

    5. Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 24 [month 24]

    6. Ganglion Cell Layer (GCL) assessed by SD-OCT at month 0 [month 0]

    7. Ganglion Cell Layer (GCL) assessed by SD-OCT at month 6 [month 6]

    8. Ganglion Cell Layer (GCL) assessed by SD-OCT at month 12 [month 12]

    9. Ganglion Cell Layer (GCL) assessed by SD-OCT at month 18 [month 18]

    10. Ganglion Cell Layer (GCL) assessed by SD-OCT at month 24 [month 24]

    11. Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at baseline [baseline]

    12. Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 6 [month 6]

    13. Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 12 [month 12]

    14. Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 18 [month 18]

    15. Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 24 [month 24]

    16. Retinal thickness assessed by SD-OCT at month 0 [month 0]

    17. Retinal thickness assessed by SD-OCT at month 6 [month 6]

    18. Retinal thickness assessed by SD-OCT at month 12 [month 12]

    19. Retinal thickness assessed by SD-OCT at month 18 [month 18]

    20. Retinal thickness assessed by SD-OCT at month 24 [month 24]

    21. Central retinal thickness assessed by SD-OCT at month 0 [month 0]

    22. Central retinal thickness assessed by SD-OCT at month 6 [month 6]

    23. Central retinal thickness assessed by SD-OCT at month 12 [month 12]

    24. Central retinal thickness assessed by SD-OCT at month 18 [month 18]

    25. Central retinal thickness assessed by SD-OCT at month 24 [month 24]

    26. Diabetic Retinopathy (DR) severity assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) scale CFP - 30º/35º-7 fields at baseline [baseline]

    27. DR severity assessed by ETDRS scale CFP - 30º/35º-7 fields at month 24 [month 24]

    Other Outcome Measures

    1. Best Corrected Visual Acuity (BCVA) assessed by ETDRS scale at month 0 [month 0]

    2. BCVA assessed by ETDRS scale at month 6 [month 6]

    3. BCVA assessed by ETDRS scale at month 12 [month 12]

    4. BCVA assessed by ETDRS scale at month 18 [month 18]

    5. BCVA assessed by ETDRS scale at month 24 [month 24]

    6. Visual Fields defects assessed by Visual Fields Test at month 0 [month 0]

    7. Visual Fields defects assessed by Visual Fields Test at month 24 [month 24]

    8. Visual health assessed by Visual Function Questionnaire (VFQ-25) at month 0 [month 0]

    9. Visual health assessed by Visual Function Questionnaire (VFQ-25) at month 24 [month 24]

    10. Adverse Events assessed by inquiry at month 0 [month 0]

    11. Adverse Events assessed by inquiry at month 3 [month 3]

    12. Adverse Events assessed by inquiry at month 6 [month 6]

    13. Adverse Events assessed by inquiry at month 12 [month 12]

    14. Adverse Events assessed by inquiry at month 18 [month 18]

    15. Adverse Events assessed by inquiry at month 24 [month 24]

    16. ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 0 [month 0]

    17. ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 3 [month 3]

    18. ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 6 [month 6]

    19. ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 12 [month 12]

    20. ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 18 [month 18]

    21. ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 24 [month 24]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Syddansk Universitet (SDU) Odense Denmark
    2 AP - Hopitaux de Paris (AP-HP) Paris France 75010
    3 Universitaet Ulm (UUlm) Ulm Germany 89081
    4 Universita Vita-Salute San Raffaele (USR) Milano Italy 20132
    5 Universita degli Study di Padova(UPadova) Padova Italy 35128
    6 Aibili - Cec Coimbra Portugal 3000-548
    7 Institut Catala de la Salut - Hospital Universitari Vall d'Hebron (ICS-HUVH) Barcelona Spain 08035
    8 Gloucestershire Hospitals NHS Foundation Trust (CHGH) Cheltenham Gloucestershire United Kingdom
    9 Aston University (UAston)Heart of England NHS Foundation Trust Birmingham United Kingdom
    10 The University of Liverpool (UOL) Liverpool United Kingdom
    11 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    BCN Peptides
    ClinicalTrials.gov Identifier:
    NCT01726075
    Other Study ID Numbers:
    • 4C-2011-02
    • 2012-001200-38
    First Posted:
    Nov 14, 2012
    Last Update Posted:
    Jan 12, 2016
    Last Verified:
    Jan 1, 2016
    Keywords provided by BCN Peptides
    diabetic retinopathy
    Additional relevant MeSH terms:
    Retinal Diseases
    Diabetic Retinopathy
    Brimonidine Tartrate
    Ophthalmic Solutions
    Somatostatin

    Study Results

    No Results Posted as of Jan 12, 2016