<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/NCT04444492</url>
  </required_header>
  <id_info>
    <org_study_id>CoRaLaII</org_study_id>
    <nct_id>NCT04444492</nct_id>
  </id_info>
  <brief_title>Combination of Ranibizumab and Targeted Laser Photocoagulation</brief_title>
  <acronym>CoRaLaII</acronym>
  <official_title>Long-term Need of Ranibizumab Injections With or Without Early Targeted Peripheral Laser Photocoagulation for Treatment of Macular Edema Due to Central Retinal Vein Occlusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Giessen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Leipzig</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Giessen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intravitreal injections of Ranibizumab will be applied in all patients according to treatment&#xD;
      guidelines. The experimental group will receive additional targeted laser photocoagulation of&#xD;
      the peripheral areas of capillary non-perfusion (up to 4 laser treatments within 1st year of&#xD;
      the study). Based on the long-term observation after CoRaLa I study an importantly shorter&#xD;
      duration of treatment and a relevant reduction of the total number of re-injections in RL&#xD;
      patients is expected.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Retinal vein occlusion (RVO) is the second most common retinal vascular disease leading to&#xD;
      visual impairment. Main cause for visual impairment in CRVO (Central Retinal Vein Occlusion)&#xD;
      is macular edema (ME) while neovascularization of the retina and/or the anterior segment is&#xD;
      the most serious complication leading to vitreous hemorrhage, retinal detachment and&#xD;
      neovascular glaucoma. In serious cases loss of vision is imminent. To date, no causal&#xD;
      treatment has been proven to be effective in large trials. Intravitreal injections of drugs&#xD;
      that inhibit the vascular endothelial growth factor (VEGF) and other inflammatory factors are&#xD;
      the current treatments of choice for ME due to CRVO. Two different anti-VEGF drugs&#xD;
      (ranibizumab and aflibercept), and a biodegradable dexamethasone implant are approved by the&#xD;
      EMA (European Medicines Agency). Based on data from confirmatory studies anti-VEGF-drugs are&#xD;
      recommended as a treatment of first choice in patients with RVO. All intravitreal drugs&#xD;
      provide only a temporary effect with need for re-treatment for recurrences of ME. Mean number&#xD;
      of ranibizumab application needed in CRVO patients was found to be 7.4 to 10.2 injections in&#xD;
      12 months. A significant number of CRVO patients require treatment over several years. Need&#xD;
      for repetitive treatments and ophthalmic controls are a major burden for patients (and their&#xD;
      relatives who are required for driving the patients to ophthalmologists) despite of only few&#xD;
      adverse events and generally well-tolerated injections. Endophthalmitis is the most severe&#xD;
      ocular complication which can be eye-sight-threatening. The more injections are administered,&#xD;
      the higher is the cumulative risk of complications. Due to high costs (&gt;1000 € per injection)&#xD;
      treatment with repeated injections over years is of significant socio-economic importance,&#xD;
      too. Therefore, treatments concepts which would lead to permanent reduction of ME and/or&#xD;
      significantly reduce the number of re-injections over long-term periods are the major&#xD;
      currently unmet need in patients with RVO.&#xD;
&#xD;
      Until now, several studies evaluated the impact of the additional pan-retinal laser&#xD;
      photocoagulation in patients undergoing the anti-VEGF-treatment for the ME due to retinal&#xD;
      vein occlusions. However, most of the studies are limited by retrospective design, small&#xD;
      number of evaluated patients or lack of the randomization. None of the available prospective&#xD;
      randomized studies had sufficient power to finally clarify the benefit of the additional&#xD;
      laser treatment. Therefore, there is an unmet need for a large randomized, prospective,&#xD;
      multicentric trials.&#xD;
&#xD;
      The proposed study will be the first sufficiently powered trial evaluating the long-term&#xD;
      effect of targeted laser photocoagulation performed selectively (targeted) in peripheral&#xD;
      areas of non-perfusion in combination with standard anti-VEGF treatment (ranibizumab&#xD;
      injections) on the duration of the required intravitreal treatment over time period of 2&#xD;
      years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 25, 2020</start_date>
  <completion_date type="Anticipated">July 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">July 30, 2025</primary_completion_date>
  <phase>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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>blinded BCVA assessor</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy endpoint is the time to treatment success</measure>
    <time_frame>up-to 29 months</time_frame>
    <description>Time from randomisation until the date of last criteria-based intravitreal injection in case that thereafter a treatment-free period for (at least) 6 months was observed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Best corrected visual acuity (BCVA)</measure>
    <time_frame>Month 29</time_frame>
    <description>Best corrected visual acuity (BCVA) in number of ETDRS letters (Early Treatment of Diabetes Retinopathy Study) per visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Central subfield thickness (CST)</measure>
    <time_frame>Month 29</time_frame>
    <description>Central subfield thickness (CST) measured by OCT per visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of ranibizumab injections</measure>
    <time_frame>Month 29</time_frame>
    <description>Number of ranibizumab injections required until treatment success and up to the end of Observation.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Development of neovascularization(s)</measure>
    <time_frame>Month 24</time_frame>
    <description>Proportion of subjects developing neovascularization(s) of retina, optic disc, and/or in anterior segment over the total period of observation.</description>
  </other_outcome>
  <other_outcome>
    <measure>The area of non-perfusion</measure>
    <time_frame>Month 24</time_frame>
    <description>The area of non-perfusion (assessed by FA) will be quantified as sum of all areas identified</description>
  </other_outcome>
  <other_outcome>
    <measure>Vessel density</measure>
    <time_frame>Month 24</time_frame>
    <description>Assessed by OCT-angiography, will be quantified by a metric measure with the range [0;1]</description>
  </other_outcome>
  <other_outcome>
    <measure>Potential visual field loss</measure>
    <time_frame>Month 4 and Month 24</time_frame>
    <description>The change between the two timepoints (Months 4 and 24) per arm will be used to characterize the both groups and be compared between treatment arms.</description>
  </other_outcome>
  <other_outcome>
    <measure>The number of laser treatments and the laser spots given in the experimental group (RL-arm).</measure>
    <time_frame>Month 24</time_frame>
    <description>The number of visits with applied laser treatment and the laser spots applied in the experimental group (RL-arm) will be counted for descriptive reasons and be compared between treatment arms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Health-related quality of life (QoL): Visual Function Questionnaire VFQ25</measure>
    <time_frame>Baseline, Month 12 and Month 24</time_frame>
    <description>Measured by the Visual Function Questionnaire VFQ25</description>
  </other_outcome>
  <other_outcome>
    <measure>Areal of foveal avascular zone</measure>
    <time_frame>Month 24</time_frame>
    <description>Area of the foveal avascular zone (FAZ, assessed by OCT-angiography, will be quantified in [mmm²])</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Central Retinal Vein Occlusion With Macular Edema</condition>
  <arm_group>
    <arm_group_label>Ranibizumab+Laser-arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ranibizumab injections and additional targeted laser</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ranibizumab-arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Only Ranibizumab injections</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ranibizumab Injection</intervention_name>
    <description>initial three injections of Ranibizumab - afterwards pro re nata monthly</description>
    <arm_group_label>Ranibizumab+Laser-arm</arm_group_label>
    <arm_group_label>Ranibizumab-arm</arm_group_label>
    <other_name>Lucentis</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laser photocoagulation</intervention_name>
    <description>Areas of capillary non-perfusion will be treated with photocoagulation upto 4 times</description>
    <arm_group_label>Ranibizumab+Laser-arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of macular edema due to central retinal vein occlusion foveal thickness &gt;&#xD;
             250 μm (measured by OCT)&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Written informed consent of the patient&#xD;
&#xD;
          -  BCVA score in the study eye between 24 letters (20/320) and 78 letters (20/25)&#xD;
             measured in ETDRS chart&#xD;
&#xD;
          -  History of CRVO no longer than 6 months&#xD;
&#xD;
          -  Presence of capillary non-perfusion in peripheral retina larger than 5 disc areas&#xD;
             documented in ultra wide-field fluorescein angiography&#xD;
&#xD;
          -  Ability and willingness to attend all scheduled visits and assessments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  CRVO with ischemic maculopathy defined as diameter of the foveolar avascular zone&#xD;
             larger than 2 optic disc diameters&#xD;
&#xD;
          -  Macular edema due to another etiology than retinal vein occlusion (e.g. diabetic&#xD;
             maculopathy, uveitis, age related macular degeneration, Irvine-Gass syndrome)&#xD;
&#xD;
          -  History of idiopathic central serous chorioretinopathy&#xD;
&#xD;
          -  Presence of vitreoretinal interface disease (e.g. vitreomacular traction, epiretinal&#xD;
             membrane), either on clinical examination or in OCT&#xD;
&#xD;
          -  An eye that, in the investigator's opinion, would not benefit from resolution of&#xD;
             macular edema, such as eyes with foveal atrophy, dense pigmentary changes, or dense&#xD;
             subfoveal hard exudates&#xD;
&#xD;
          -  Aphakia in the study eye&#xD;
&#xD;
          -  Scatter laser photocoagulation or macular photocoagulation in the study eye prior to&#xD;
             study entry&#xD;
&#xD;
          -  Intraocular or periocular injection of steroids in the study eye prior to study entry&#xD;
&#xD;
          -  Previous use of an anti-VEGF drug in the study eye&#xD;
&#xD;
          -  Cataract surgery or any other intraocular surgery in the study eye within 3 months&#xD;
             prior to study entry&#xD;
&#xD;
          -  Uncontrolled glaucoma (defined as intraocular pressure ≥ 30 mm Hg despite treatment&#xD;
             with maximal anti-glaucoma medications)&#xD;
&#xD;
          -  History of stroke, myocardial infarction, transient ischemic attacks within 3 months&#xD;
             prior to the study&#xD;
&#xD;
          -  Pregnancy (positive urine pregnancy test) or lactation&#xD;
&#xD;
          -  The presence of active malignancy, including lymphoproliferative disorders.&#xD;
&#xD;
          -  History of allergy to fluorescein or any component of the ranibizumab formulation&#xD;
&#xD;
          -  Active intraocular infection&#xD;
&#xD;
          -  Participation in another simultaneous interventional medical investigation or trial&#xD;
&#xD;
          -  Women with child bearing potency without effective contraception (i. e. implants,&#xD;
             injectables, combined oral contraceptives, some IUDs or vasectomised partner) during&#xD;
             the conduct of the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matus Rehak, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Department of Ophthalmology Justus-Liebig-Universität Giessen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Matus Rehak, Professor</last_name>
    <phone>0049 641 985 438 01</phone>
    <email>matus.rehak@uk-gm.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yasmine Breitenstein</last_name>
    <phone>0049 341 97 16 247</phone>
    <email>yasmine.breitenstein@zks.uni-leipzig.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Universitätsklinikum Carl Gustav Carus Dresden Klinik und Polyklinik für Augenheilkunde</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Dirk Sandner, Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Internationale Innovative Ophthalmochirurgie GbR, Klinik für Augenchirurgie</name>
      <address>
        <city>Düsseldorf</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hakan Kaymak, Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Klinik für Augenheilkunde Freiburg</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hansjürgen Agostini, Prof.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Gießen, Klinik und Poliklinik für Augenheilkunde</name>
      <address>
        <city>Gießen</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matus Rehak, Prof. MUDr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hannover MHH Universitätsklinik für Augenheilkunde</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amelie Pielen, PD. Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital of Leipzig Department of Ophthalmology</name>
      <address>
        <city>Leipzig</city>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Focke Ziemssen, Prof. Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Klinikum der Stadt Ludwigshafen Augenklinik</name>
      <address>
        <city>Ludwigshafen</city>
        <zip>67063</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lars-Olof Hattenbach, Prof.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Gießen und Marburg GmbH, Standort Marburg Klinik für Augenheilkunde</name>
      <address>
        <city>Marburg</city>
        <zip>35043</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Walter Sekundo, Prof.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ludwig-Maximilians-Universität München, Augenklinik</name>
      <address>
        <city>München</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Siegfried Prieglinger, Prof. Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Augenzentrum am St. Franziskus-Hospital Münster</name>
      <address>
        <city>Münster</city>
        <zip>48145</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Georg Spital, Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Klinik für Augenheilkunde</name>
      <address>
        <city>Münster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Tübingen, Department für Augenheilkunde</name>
      <address>
        <city>Tübingen</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexandra Schweig, Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Ulm, Klinik für Augenheilkunde</name>
      <address>
        <city>Ulm</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Armin Hilmar Wolf, Prof. Dr.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Augen-OP-Zentrum Zschopau, Praxis für Augenheilkunde</name>
      <address>
        <city>Zschopau</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Simo Murovski, Dr.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>July 10, 2023</last_update_submitted>
  <last_update_submitted_qc>July 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>retinal vein occlusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Edema</mesh_term>
    <mesh_term>Retinal Vein Occlusion</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ranibizumab</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/NCT04444492
org study id: CoRaLaII
nct id: NCT04444492
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Intravitreal injections of Ranibizumab will be applied in all patients according to treatment
      guidelines. The experimental group will receive additional targeted laser photocoagulation of
      the peripheral areas of capillary non-perfusion (up to 4 laser treatments within 1st year of
      the study). Based on the long-term observation after CoRaLa I study an importantly shorter
      duration of treatment and a relevant reduction of the total number of re-injections in RL
      patients is expected.
Retinal vein occlusion (RVO) is the second most common retinal vascular disease leading to
      visual impairment. Main cause for visual impairment in CRVO (Central Retinal Vein Occlusion)
      is macular edema (ME) while neovascularization of the retina and/or the anterior segment is
      the most serious complication leading to vitreous hemorrhage, retinal detachment and
      neovascular glaucoma. In serious cases loss of vision is imminent. To date, no causal
      treatment has been proven to be effective in large trials. Intravitreal injections of drugs
      that inhibit the vascular endothelial growth factor (VEGF) and other inflammatory factors are
      the current treatments of choice for ME due to CRVO. Two different anti-VEGF drugs
      (ranibizumab and aflibercept), and a biodegradable dexamethasone implant are approved by the
      EMA (European Medicines Agency). Based on data from confirmatory studies anti-VEGF-drugs are
      recommended as a treatment of first choice in patients with RVO. All intravitreal drugs
      provide only a temporary effect with need for re-treatment for recurrences of ME. Mean number
      of ranibizumab application needed in CRVO patients was found to be 7.4 to 10.2 injections in
      12 months. A significant number of CRVO patients require treatment over several years. Need
      for repetitive treatments and ophthalmic controls are a major burden for patients (and their
      relatives who are required for driving the patients to ophthalmologists) despite of only few
      adverse events and generally well-tolerated injections. Endophthalmitis is the most severe
      ocular complication which can be eye-sight-threatening. The more injections are administered,
      the higher is the cumulative risk of complications. Due to high costs (>1000 € per injection)
      treatment with repeated injections over years is of significant socio-economic importance,
      too. Therefore, treatments concepts which would lead to permanent reduction of ME and/or
      significantly reduce the number of re-injections over long-term periods are the major
      currently unmet need in patients with RVO.

      Until now, several studies evaluated the impact of the additional pan-retinal laser
      photocoagulation in patients undergoing the anti-VEGF-treatment for the ME due to retinal
      vein occlusions. However, most of the studies are limited by retrospective design, small
      number of evaluated patients or lack of the randomization. None of the available prospective
      randomized studies had sufficient power to finally clarify the benefit of the additional
      laser treatment. Therefore, there is an unmet need for a large randomized, prospective,
      multicentric trials.

      The proposed study will be the first sufficiently powered trial evaluating the long-term
      effect of targeted laser photocoagulation performed selectively (targeted) in peripheral
      areas of non-perfusion in combination with standard anti-VEGF treatment (ranibizumab
      injections) on the duration of the required intravitreal treatment over time period of 2
      years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: blinded BCVA assessor
measure: Efficacy endpoint is the time to treatment success
time frame: up-to 29 months
description: Time from randomisation until the date of last criteria-based intravitreal injection in case that thereafter a treatment-free period for (at least) 6 months was observed.
measure: Best corrected visual acuity (BCVA)
time frame: Month 29
description: Best corrected visual acuity (BCVA) in number of ETDRS letters (Early Treatment of Diabetes Retinopathy Study) per visit
measure: Central subfield thickness (CST)
time frame: Month 29
description: Central subfield thickness (CST) measured by OCT per visit
measure: Number of ranibizumab injections
time frame: Month 29
description: Number of ranibizumab injections required until treatment success and up to the end of Observation.
measure: Development of neovascularization(s)
time frame: Month 24
description: Proportion of subjects developing neovascularization(s) of retina, optic disc, and/or in anterior segment over the total period of observation.
measure: The area of non-perfusion
time frame: Month 24
description: The area of non-perfusion (assessed by FA) will be quantified as sum of all areas identified
measure: Vessel density
time frame: Month 24
description: Assessed by OCT-angiography, will be quantified by a metric measure with the range [0;1]
measure: Potential visual field loss
time frame: Month 4 and Month 24
description: The change between the two timepoints (Months 4 and 24) per arm will be used to characterize the both groups and be compared between treatment arms.
measure: The number of laser treatments and the laser spots given in the experimental group (RL-arm).
time frame: Month 24
description: The number of visits with applied laser treatment and the laser spots applied in the experimental group (RL-arm) will be counted for descriptive reasons and be compared between treatment arms.
measure: Health-related quality of life (QoL): Visual Function Questionnaire VFQ25
time frame: Baseline, Month 12 and Month 24
description: Measured by the Visual Function Questionnaire VFQ25
measure: Areal of foveal avascular zone
time frame: Month 24
description: Area of the foveal avascular zone (FAZ, assessed by OCT-angiography, will be quantified in [mmm²])
arm group label: Ranibizumab+Laser-arm
arm group type: Experimental
description: Ranibizumab injections and additional targeted laser
arm group label: Ranibizumab-arm
arm group type: Active Comparator
description: Only Ranibizumab injections
intervention type: Drug
intervention name: Ranibizumab Injection
description: initial three injections of Ranibizumab - afterwards pro re nata monthly
arm group label: Ranibizumab+Laser-arm
arm group label: Ranibizumab-arm
other name: Lucentis
intervention type: Device
intervention name: Laser photocoagulation
description: Areas of capillary non-perfusion will be treated with photocoagulation upto 4 times
arm group label: Ranibizumab+Laser-arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matus Rehak, Professor
role: Study Director
affiliation: Department of Ophthalmology Justus-Liebig-Universität Giessen
last name: Matus Rehak, Professor
phone: 0049 641 985 438 01
email: matus.rehak@uk-gm.de
last name: Yasmine Breitenstein
phone: 0049 341 97 16 247
email: yasmine.breitenstein@zks.uni-leipzig.de
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Sponsor
mesh term: Macular Edema
mesh term: Retinal Vein Occlusion
mesh term: Ranibizumab