<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01726075</url>
  </required_header>
  <id_info>
    <org_study_id>4C-2011-02</org_study_id>
    <secondary_id>2012-001200-38</secondary_id>
    <nct_id>NCT01726075</nct_id>
  </id_info>
  <brief_title>Trial to Assess the Efficacy of Neuroprotective Drugs Administered Topically to Prevent or Arrest Diabetic Retinopathy</brief_title>
  <acronym>EUROCONDOR</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BCN Peptides</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BCN Peptides</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess whether neuroprotective drugs administered topically (somatostatin and brimonidine)&#xD;
      are able to prevent or arrest the development and progression of neurodegenerative changes&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To assess whether neuroprotective drugs administered topically (somatostatin and brimonidine)&#xD;
      are able to prevent or arrest the development and progression of neurodegenerative changes&#xD;
      related to diabetic retinopathy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in the Implicit Time assessed by mfERG (IT-mfERG) at month 6, 12, 18 and 24</measure>
    <time_frame>month 24</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Retinal Nerve Fiber Layer (RNFL) assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) at month 0</measure>
    <time_frame>month 0</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 6</measure>
    <time_frame>month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 12</measure>
    <time_frame>month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 18</measure>
    <time_frame>month 18</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 24</measure>
    <time_frame>month 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ganglion Cell Layer (GCL) assessed by SD-OCT at month 0</measure>
    <time_frame>month 0</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ganglion Cell Layer (GCL) assessed by SD-OCT at month 6</measure>
    <time_frame>month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ganglion Cell Layer (GCL) assessed by SD-OCT at month 12</measure>
    <time_frame>month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ganglion Cell Layer (GCL) assessed by SD-OCT at month 18</measure>
    <time_frame>month 18</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ganglion Cell Layer (GCL) assessed by SD-OCT at month 24</measure>
    <time_frame>month 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at baseline</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 6</measure>
    <time_frame>month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 12</measure>
    <time_frame>month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 18</measure>
    <time_frame>month 18</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 24</measure>
    <time_frame>month 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retinal thickness assessed by SD-OCT at month 0</measure>
    <time_frame>month 0</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retinal thickness assessed by SD-OCT at month 6</measure>
    <time_frame>month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retinal thickness assessed by SD-OCT at month 12</measure>
    <time_frame>month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retinal thickness assessed by SD-OCT at month 18</measure>
    <time_frame>month 18</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retinal thickness assessed by SD-OCT at month 24</measure>
    <time_frame>month 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Central retinal thickness assessed by SD-OCT at month 0</measure>
    <time_frame>month 0</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Central retinal thickness assessed by SD-OCT at month 6</measure>
    <time_frame>month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Central retinal thickness assessed by SD-OCT at month 12</measure>
    <time_frame>month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Central retinal thickness assessed by SD-OCT at month 18</measure>
    <time_frame>month 18</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Central retinal thickness assessed by SD-OCT at month 24</measure>
    <time_frame>month 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetic Retinopathy (DR) severity assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) scale CFP - 30º/35º-7 fields at baseline</measure>
    <time_frame>baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DR severity assessed by ETDRS scale CFP - 30º/35º-7 fields at month 24</measure>
    <time_frame>month 24</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Best Corrected Visual Acuity (BCVA) assessed by ETDRS scale at month 0</measure>
    <time_frame>month 0</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>BCVA assessed by ETDRS scale at month 6</measure>
    <time_frame>month 6</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>BCVA assessed by ETDRS scale at month 12</measure>
    <time_frame>month 12</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>BCVA assessed by ETDRS scale at month 18</measure>
    <time_frame>month 18</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>BCVA assessed by ETDRS scale at month 24</measure>
    <time_frame>month 24</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Visual Fields defects assessed by Visual Fields Test at month 0</measure>
    <time_frame>month 0</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Visual Fields defects assessed by Visual Fields Test at month 24</measure>
    <time_frame>month 24</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Visual health assessed by Visual Function Questionnaire (VFQ-25) at month 0</measure>
    <time_frame>month 0</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Visual health assessed by Visual Function Questionnaire (VFQ-25) at month 24</measure>
    <time_frame>month 24</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Adverse Events assessed by inquiry at month 0</measure>
    <time_frame>month 0</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Adverse Events assessed by inquiry at month 3</measure>
    <time_frame>month 3</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Adverse Events assessed by inquiry at month 6</measure>
    <time_frame>month 6</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Adverse Events assessed by inquiry at month 12</measure>
    <time_frame>month 12</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Adverse Events assessed by inquiry at month 18</measure>
    <time_frame>month 18</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Adverse Events assessed by inquiry at month 24</measure>
    <time_frame>month 24</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 0</measure>
    <time_frame>month 0</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 3</measure>
    <time_frame>month 3</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 6</measure>
    <time_frame>month 6</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 12</measure>
    <time_frame>month 12</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 18</measure>
    <time_frame>month 18</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 24</measure>
    <time_frame>month 24</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">450</enrollment>
  <condition>Diabetic Retinopathy</condition>
  <arm_group>
    <arm_group_label>COLIRIOBCN070660</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>COLIRIOBCN070660 Somatostatin 1mg/mL Eye drops, solution. One drop/eye administered twice a day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Eye drops, solution. One drop/eye administered twice a day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Brimonidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Brimonidine tartrate 2mg/mL One drop/eye administered twice a day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>COLIRIOBCN070660</intervention_name>
    <description>One drop per eye twice a day during 24 months</description>
    <arm_group_label>COLIRIOBCN070660</arm_group_label>
    <other_name>Somatostatin eye drops</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>One drop per eye twice a day during 24 months</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>placebo eye drops</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Brimonidine</intervention_name>
    <description>One drop per eye twice a day during 24 months</description>
    <arm_group_label>Brimonidine</arm_group_label>
    <other_name>Brimonidine eye drops</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with type 2 diabetes mellitus&#xD;
&#xD;
          2. Diabetes duration ≥ 5 years&#xD;
&#xD;
          3. Aged between 45-75 years-old&#xD;
&#xD;
          4. ETDRS level &lt; 20 (microaneurysms absent) (50% of enrolled patients) Or ETDRS levels 20&#xD;
             or 35 with presence of at least one microaneurysm in Field 2 between the superior and&#xD;
             inferior arcades (50% of enrolled patients) in the Study Eye as determined by the&#xD;
             Reading Centre.&#xD;
&#xD;
          5. Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous laser photocoagulation&#xD;
&#xD;
          2. Other diseases which may induce retinal degeneration (e.g. glaucoma)&#xD;
&#xD;
          3. Subject with a refractive error ≥ ± 5 diopter&#xD;
&#xD;
          4. Inadequate ocular media and/ or pupil dilatation that do not permit good quality&#xD;
             fundus photography.&#xD;
&#xD;
          5. Renal failure (creatinine &gt; 1.4 mg/dl)&#xD;
&#xD;
          6. HbA1C &gt; 10 % in the previous 6 months and at Screening&#xD;
&#xD;
          7. Subjects taking somatostatin or brimonidine, for any indication, in the previous 3&#xD;
             months&#xD;
&#xD;
          8. Subject has a condition or is in a situation which may put the subject at significant&#xD;
             risk, may confound the study results or may interfere significantly with the patient's&#xD;
             participation in the study.&#xD;
&#xD;
          9. Pregnancy or nursing&#xD;
&#xD;
         10. Hypersensitivity to the active substances to be tested or to any of the excipients&#xD;
&#xD;
         11. Subject receiving systemic monoamine oxidase (MAO) inhibitor therapy or&#xD;
             antidepressants which affect noradrenergic transmission (e.g. tricyclic&#xD;
             antidepressants and mianserin)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>José Cunha-Vaz, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Association for Innovation and Biomedical Research on Light and Image</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Syddansk Universitet (SDU)</name>
      <address>
        <city>Odense</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AP - Hopitaux de Paris (AP-HP)</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaet Ulm (UUlm)</name>
      <address>
        <city>Ulm</city>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universita Vita-Salute San Raffaele (USR)</name>
      <address>
        <city>Milano</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universita degli Study di Padova(UPadova)</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aibili - Cec</name>
      <address>
        <city>Coimbra</city>
        <zip>3000-548</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Catala de la Salut - Hospital Universitari Vall d'Hebron (ICS-HUVH)</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gloucestershire Hospitals NHS Foundation Trust (CHGH)</name>
      <address>
        <city>Cheltenham</city>
        <state>Gloucestershire</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aston University (UAston)Heart of England NHS Foundation Trust</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Liverpool (UOL)</name>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moorfields Eye Hospital NHS Foundation Trust (MEH)</name>
      <address>
        <city>London</city>
        <zip>EC1V2PD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Portugal</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>January 11, 2016</last_update_submitted>
  <last_update_submitted_qc>January 11, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>diabetic retinopathy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Diseases</mesh_term>
    <mesh_term>Diabetic Retinopathy</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brimonidine Tartrate</mesh_term>
    <mesh_term>Ophthalmic Solutions</mesh_term>
    <mesh_term>Somatostatin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01726075
org study id: 4C-2011-02
secondary id: 2012-001200-38
nct id: NCT01726075
lead sponsor: 
has dmc: Yes
To assess whether neuroprotective drugs administered topically (somatostatin and brimonidine)
      are able to prevent or arrest the development and progression of neurodegenerative changes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Changes in the Implicit Time assessed by mfERG (IT-mfERG) at month 6, 12, 18 and 24
time frame: month 24
measure: Retinal Nerve Fiber Layer (RNFL) assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) at month 0
time frame: month 0
measure: Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 6
time frame: month 6
measure: Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 12
time frame: month 12
measure: Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 18
time frame: month 18
measure: Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 24
time frame: month 24
measure: Ganglion Cell Layer (GCL) assessed by SD-OCT at month 0
time frame: month 0
measure: Ganglion Cell Layer (GCL) assessed by SD-OCT at month 6
time frame: month 6
measure: Ganglion Cell Layer (GCL) assessed by SD-OCT at month 12
time frame: month 12
measure: Ganglion Cell Layer (GCL) assessed by SD-OCT at month 18
time frame: month 18
measure: Ganglion Cell Layer (GCL) assessed by SD-OCT at month 24
time frame: month 24
measure: Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at baseline
time frame: baseline
measure: Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 6
time frame: month 6
measure: Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 12
time frame: month 12
measure: Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 18
time frame: month 18
measure: Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 24
time frame: month 24
measure: Retinal thickness assessed by SD-OCT at month 0
time frame: month 0
measure: Retinal thickness assessed by SD-OCT at month 6
time frame: month 6
measure: Retinal thickness assessed by SD-OCT at month 12
time frame: month 12
measure: Retinal thickness assessed by SD-OCT at month 18
time frame: month 18
measure: Retinal thickness assessed by SD-OCT at month 24
time frame: month 24
measure: Central retinal thickness assessed by SD-OCT at month 0
time frame: month 0
measure: Central retinal thickness assessed by SD-OCT at month 6
time frame: month 6
measure: Central retinal thickness assessed by SD-OCT at month 12
time frame: month 12
measure: Central retinal thickness assessed by SD-OCT at month 18
time frame: month 18
measure: Central retinal thickness assessed by SD-OCT at month 24
time frame: month 24
measure: Diabetic Retinopathy (DR) severity assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) scale CFP - 30º/35º-7 fields at baseline
time frame: baseline
measure: DR severity assessed by ETDRS scale CFP - 30º/35º-7 fields at month 24
time frame: month 24
measure: Best Corrected Visual Acuity (BCVA) assessed by ETDRS scale at month 0
time frame: month 0
measure: BCVA assessed by ETDRS scale at month 6
time frame: month 6
measure: BCVA assessed by ETDRS scale at month 12
time frame: month 12
measure: BCVA assessed by ETDRS scale at month 18
time frame: month 18
measure: BCVA assessed by ETDRS scale at month 24
time frame: month 24
measure: Visual Fields defects assessed by Visual Fields Test at month 0
time frame: month 0
measure: Visual Fields defects assessed by Visual Fields Test at month 24
time frame: month 24
measure: Visual health assessed by Visual Function Questionnaire (VFQ-25) at month 0
time frame: month 0
measure: Visual health assessed by Visual Function Questionnaire (VFQ-25) at month 24
time frame: month 24
measure: Adverse Events assessed by inquiry at month 0
time frame: month 0
measure: Adverse Events assessed by inquiry at month 3
time frame: month 3
measure: Adverse Events assessed by inquiry at month 6
time frame: month 6
measure: Adverse Events assessed by inquiry at month 12
time frame: month 12
measure: Adverse Events assessed by inquiry at month 18
time frame: month 18
measure: Adverse Events assessed by inquiry at month 24
time frame: month 24
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
arm group label: COLIRIOBCN070660
arm group type: Experimental
description: COLIRIOBCN070660 Somatostatin 1mg/mL Eye drops, solution. One drop/eye administered twice a day.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo Eye drops, solution. One drop/eye administered twice a day.
arm group label: Brimonidine
arm group type: Experimental
description: Brimonidine tartrate 2mg/mL One drop/eye administered twice a day.
intervention type: Drug
intervention name: COLIRIOBCN070660
description: One drop per eye twice a day during 24 months
arm group label: COLIRIOBCN070660
other name: Somatostatin eye drops
intervention type: Drug
intervention name: Placebo
description: One drop per eye twice a day during 24 months
arm group label: Placebo
other name: placebo eye drops
intervention type: Drug
intervention name: Brimonidine
description: One drop per eye twice a day during 24 months
arm group label: Brimonidine
other name: Brimonidine eye drops
criteria: 
gender: All
minimum age: 45 Years
maximum age: 75 Years
healthy volunteers: No
last name: José Cunha-Vaz, Prof.
role: Principal Investigator
affiliation: Association for Innovation and Biomedical Research on Light and Image
facility: 
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country: Denmark
country: France
country: Germany
country: Italy
country: Portugal
country: Spain
country: United Kingdom
responsible party type: Sponsor
mesh term: Retinal Diseases
mesh term: Diabetic Retinopathy
mesh term: Brimonidine Tartrate
mesh term: Ophthalmic Solutions
mesh term: Somatostatin