<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/NCT02976012</url>
  </required_header>
  <id_info>
    <org_study_id>VGFTe-DR-1548</org_study_id>
    <nct_id>NCT02976012</nct_id>
  </id_info>
  <brief_title>Endolaserless Vitrectomy With Intravitreal IAI for PDR-Related VH</brief_title>
  <acronym>LASERLESS</acronym>
  <official_title>Endolaserless Vitrectomy With Intravitreal Aflibercept Injection for Proliferative Diabetic Retinopathy-Related Vitreous Hemorrhage (LASER LESS TRIAL)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Southeast Retina Center, Georgia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Southeast Retina Center, Georgia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase I/II open label, randomized, interventional clinical trial. Study eyes will&#xD;
      receive one preoperative intravitreal aflibercept injection (IAI) &lt;21 days but &gt;7 days prior&#xD;
      to vitrectomy and one intraoperative IAI at end of surgery followed by randomization in a 1:1&#xD;
      ratio into either 4 mandatory postoperative q4weeks IAI followed by mandatory q8 weeks IAI&#xD;
      for 52 weeks follow-up (q8 week Group) or 2 mandatory postoperative q4weeks IAI followed by&#xD;
      mandatory q16 weeks IAI for 52 weeks follow-up (q16 week Group).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase I/II open label, randomized, interventional clinical trial. Study eyes will&#xD;
      receive one preoperative intravitreal aflibercept injection (IAI) &lt;21 days but &gt;7 days prior&#xD;
      to vitrectomy and one intraoperative intravitreal aflibercept at end of surgery followed by&#xD;
      randomization in a 1:1 ratio into either 4 mandatory postoperative q4weeks IAI followed by&#xD;
      mandatory q8 weeks IAI for 52 weeks follow-up (q8 week Group) or 2 mandatory postoperative&#xD;
      q4weeks IAI followed by mandatory q16 weeks IAI for 52 weeks follow-up (q16 week Group).&#xD;
&#xD;
      Follow-up visits occur 1 day and 1-2 weeks, and 4 weeks postoperatively and then every 4&#xD;
      weeks from the first postoperative IAI for 52 weeks. One preoperative visit and every&#xD;
      postoperative visit (except day one postoperatively) will include ETDRS Best Corrected Visual&#xD;
      Acuity (BCVA), Intraocular Pressure (IOP) measurement, Slit lamp biomicroscopy, Indirect&#xD;
      ophthalmoscopy, Heidelberg Spectralis Spectral Domain Optical Coherence Tomography (SD-OCT)&#xD;
      (no OCT for preoperative visit) and evaluation for systemic and ocular adverse events. Seven&#xD;
      standard field photographs and Optos wide-field fluorescein angiography will be performed at&#xD;
      postoperative visits at 4, 16, 28, 40,and 52 weeks. Humphrey visual field (HVF) testing (30-2&#xD;
      and 60-4 test patterns) will be performed at postoperative visits at 4 and 52 weeks.&#xD;
      Preoperative B scan echography will be required standard of care(SOC) to assess for macular&#xD;
      traction, non-macular traction, retinal detachment and vitreous hemorrhage(VH).&#xD;
      Identification of traction macular detachment will exclude the patient from the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2016</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">June 2018</primary_completion_date>
  <phase>Phase 1/Phase 2</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>• Ocular and systemic safety evaluation for adverse events at any time point through 52 weeks:</measure>
    <time_frame>Through 52 weeks from Baseline</time_frame>
    <description>Examples include worsened acuity &gt;30 letters, rhegmatogenous or tractional retinal detachment, endophthalmitis, new or increased vitreous hemorrhage, cataract progression or surgery, need for additional vitrectomy or scleral buckle, development of new DME after OCT documentation of absence of DME, systemic thromboembolic events, deaths and systemic serious adverse events at any time point through week 52.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean change in BCVA letter score</measure>
    <time_frame>52 weeks from Baseline</time_frame>
    <description>Mean change in BCVA letter score over time through week 52</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean BCVA letter score</measure>
    <time_frame>52 weeks from Baseline</time_frame>
    <description>Mean BCVA letter score over time through week 52</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of eyes with progression of PDR</measure>
    <time_frame>Through 52 weeks from Baseline</time_frame>
    <description>Proportion of eyes with progression of PDR as defined above at any time point through week 52</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean OCT CSF thickness</measure>
    <time_frame>Through 52 weeks from Baseline</time_frame>
    <description>Mean OCT CSF thickness over time through week 52</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of eyes with OCT CSF thickness &lt;300um</measure>
    <time_frame>Through 52 weeks from Baseline</time_frame>
    <description>Proportion of eyes with OCT CSF thickness &lt;300um at week 52</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of eyes with absence of Optos widefield fluorescein angiographic macular leakage</measure>
    <time_frame>Through 52 weeks from Baseline</time_frame>
    <description>Proportion of eyes with absence of Optos widefield fluorescein angiographic macular leakage at week 52</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of eyes with absence of active neovascularization</measure>
    <time_frame>Through 52 weeks from Baseline</time_frame>
    <description>Proportion of eyes with absence of active neovascularization by Optos widefield fluorescein angiography at week 52</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of eyes with absence of active neovascularization</measure>
    <time_frame>Through 52 weeks from Baseline</time_frame>
    <description>Proportion of eyes with absence of active neovascularization by 7 standard field photography at week 52</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of eyes with unchanged, worsened, or improved fluorescein angiographic macular leakage</measure>
    <time_frame>Through 52 weeks from Baseline</time_frame>
    <description>Proportion of eyes with unchanged, worsened, or improved fluorescein angiographic macular leakage from baseline angiograms at week 52</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of eyes with unchanged, worsened, or improved fluorescein angiographic neovascularization</measure>
    <time_frame>Through 52 weeks from Baseline</time_frame>
    <description>Proportion of eyes with unchanged, worsened, or improved fluorescein angiographic neovascularization from baseline angiograms at week 52</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of eyes with unchanged, worsened, or improved fundus photographic DME appearance</measure>
    <time_frame>Through 52 weeks from Baseline</time_frame>
    <description>Proportion of eyes with unchanged, worsened, or improved fundus photographic DME appearance from baseline photographs at week 52</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean cumulative score and change for the combined 30-2 and 60-4 HVF test</measure>
    <time_frame>Through 52 weeks from Baseline</time_frame>
    <description>Mean cumulative score and change for the combined 30-2 and 60-4 HVF test from week 4 to week 52.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of eyes requiring additional IAI other than mandatory injections</measure>
    <time_frame>Through 52 weeks from Baseline</time_frame>
    <description>Proportion of eyes requiring additional IAI other than mandatory injections through week 52</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of eye with progression of PDR requiring rescue PRP standard of care</measure>
    <time_frame>Through 52 weeks from Baseline</time_frame>
    <description>Proportion of eye with progression of PDR requiring rescue PRP standard of care at any time point through 52 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of eyes requiring PRP or retinopexy</measure>
    <time_frame>Through 52 weeks from Baseline</time_frame>
    <description>Proportion of eyes requiring PRP or retinopexy through week 52</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of eyes requiring additional vitrectomy</measure>
    <time_frame>Through 52 weeks from Baseline</time_frame>
    <description>Proportion of eyes requiring additional vitrectomy through week 52</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of enrolled eyes requiring intraoperative endolaser in a PRP pattern at the time of initial vitrectomy</measure>
    <time_frame>Through 52 weeks from Baseline</time_frame>
    <description>Proportion of enrolled eyes requiring intraoperative endolaser in a PRP pattern at the time of initial vitrectomy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Proliferative Diabetic Retinopathy</condition>
  <arm_group>
    <arm_group_label>IAI q8 week Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Eyes will be randomized on the day of endolaserless vitrectomy surgery or first postoperative 1-2 week visit to a group (&quot;q8 week Group&quot;) where 4 additional mandatory postoperative q4weeks IAI followed by mandatory q8 weeks IAI for 52 weeks follow-up. Starting at week 20 in the q8week group eyes may be eligible to receive additional 2mg IAI (intravitreal aflibercept) (monthly) treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IAI q16 week Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Eyes will be randomized on the day of endolaserless vitrectomy surgery or first postoperative 1-2 week visit to a group (q16week Group) where 2 additional mandatory postoperative q4weeks IAI will be followed by mandatory q16weeks IAI for 52 weeks follow-up. Starting at week 12 in the q16 group, eyes may be eligible to receive additional 2mg IAI (intravitreal aflibercept) (monthly) treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aflibercept</intervention_name>
    <description>. Study eyes will receive one preoperative intravitreal aflibercept injection (IAI) &lt;21 days prior to vitrectomy and one intraoperative intravitreal aflibercept at end of surgery. Eyes will be randomized on the day of surgery or 1-2 weeks post-operatively to either a q8week IAI dosing regimen group or a q16week IAI dosing regimen group.</description>
    <arm_group_label>IAI q16 week Group</arm_group_label>
    <arm_group_label>IAI q8 week Group</arm_group_label>
    <other_name>Eylea</other_name>
    <other_name>2 mg/0.05 mL single use vial for intravitreal injection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endolaserless Vitrectomy</intervention_name>
    <description>Endolaserless vitrectomy and intraoperative and postoperative IAI in patients with PDR-related vitreous hemorrhage</description>
    <arm_group_label>IAI q16 week Group</arm_group_label>
    <arm_group_label>IAI q8 week Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults age &gt;18 years with Diabetes Mellitus&#xD;
&#xD;
          2. PDR- related vitreous hemorrhage and not of another cause&#xD;
&#xD;
          3. BCVA Vision LP or better&#xD;
&#xD;
          4. Investigator determination that vitrectomy indicated for PDR-related vitreous&#xD;
             hemorrhage&#xD;
&#xD;
          5. Willing and able to comply with clinic visits and study-related procedures&#xD;
&#xD;
          6. Provide HIPPA and signed informed consent prior to any study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. A condition per investigator opinion, would preclude participation in the study&#xD;
             (unstable medical status, cardiovascular disease, glycemic control, inability to&#xD;
             follow up etc.)&#xD;
&#xD;
          2. Participation in an investigational trial within 30 days of enrollment&#xD;
&#xD;
          3. Known allergy to IAI&#xD;
&#xD;
          4. Systemic anti-VEGF or pro-VEGF treatment within 4 months of enrollment&#xD;
&#xD;
          5. For women of childbearing age, pregnant or lactating or intending to become pregnant&#xD;
             within the next 3 years&#xD;
&#xD;
          6. History of PRP or peripheral retinal cryopexy or peripheral retinopexy for any reason&#xD;
             in the study eye&#xD;
&#xD;
          7. History of vitrectomy in the study eye&#xD;
&#xD;
          8. History or evidence for rhegmatogenous retinal detachment in the study eye&#xD;
&#xD;
          9. Evidence of traction retinal detachment involving or threatening central macula in the&#xD;
             study eye&#xD;
&#xD;
         10. Exam evident of external ocular infection (i.e. conjunctivitis, significant&#xD;
             blepharitis, chalazion etc)&#xD;
&#xD;
         11. Intravitreal anti-VEGF injection in the study eye &lt;4weeks from enrollment.&#xD;
&#xD;
         12. Pregnant or breast-feeding women&#xD;
&#xD;
         13. Sexually active men* or women of childbearing potential** who are unwilling to&#xD;
             practice adequate contraception during the study (adequate contraceptive measures&#xD;
             include stable use of oral contraceptives or other prescription pharmaceutical&#xD;
             contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device&#xD;
             [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or&#xD;
             jelly, or diaphragm plus contraceptive sponge, foam, or jelly) *Contraception is not&#xD;
             required for men with documented vasectomy. **Postmenopausal women must be amenorrheic&#xD;
             for at least 12 months in order not to be considered of child bearing potential.&#xD;
             Pregnancy testing and contraception are not required for women with documented&#xD;
             hysterectomy or tubal ligation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dennis M Marcus, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Southeast Retina Center, PC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dennis M Marcus, MD</last_name>
    <phone>706-650-0061</phone>
    <email>dmarcus@southeastretina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Siobhan Ortiz</last_name>
    <phone>706-650-0061</phone>
    <email>siobhan@southeastretina.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Southeast Retina Center, PC</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30809</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Siobhan Ortiz</last_name>
      <phone>706-650-0061</phone>
    </contact>
    <contact_backup>
      <last_name>Dennis M Marcus, MD</last_name>
      <phone>706-650-0061</phone>
      <email>dmarcus@southeastretina.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 4, 2015</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>November 23, 2016</last_update_submitted>
  <last_update_submitted_qc>November 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Southeast Retina Center, Georgia</investigator_affiliation>
    <investigator_full_name>Dennis M. Marcus, M.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Proliferative Diabetic Retinopathy</keyword>
  <keyword>Aflibercept</keyword>
  <keyword>Vitreous Hemorrhage</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>
    <mesh_term>Vitreous Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aflibercept</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02976012
org study id: VGFTe-DR-1548
nct id: NCT02976012
lead sponsor: 
has dmc: No
This is a phase I/II open label, randomized, interventional clinical trial. Study eyes will
      receive one preoperative intravitreal aflibercept injection (IAI) <21 days but >7 days prior
      to vitrectomy and one intraoperative IAI at end of surgery followed by randomization in a 1:1
      ratio into either 4 mandatory postoperative q4weeks IAI followed by mandatory q8 weeks IAI
      for 52 weeks follow-up (q8 week Group) or 2 mandatory postoperative q4weeks IAI followed by
      mandatory q16 weeks IAI for 52 weeks follow-up (q16 week Group).
This is a phase I/II open label, randomized, interventional clinical trial. Study eyes will
      receive one preoperative intravitreal aflibercept injection (IAI) <21 days but >7 days prior
      to vitrectomy and one intraoperative intravitreal aflibercept at end of surgery followed by
      randomization in a 1:1 ratio into either 4 mandatory postoperative q4weeks IAI followed by
      mandatory q8 weeks IAI for 52 weeks follow-up (q8 week Group) or 2 mandatory postoperative
      q4weeks IAI followed by mandatory q16 weeks IAI for 52 weeks follow-up (q16 week Group).

      Follow-up visits occur 1 day and 1-2 weeks, and 4 weeks postoperatively and then every 4
      weeks from the first postoperative IAI for 52 weeks. One preoperative visit and every
      postoperative visit (except day one postoperatively) will include ETDRS Best Corrected Visual
      Acuity (BCVA), Intraocular Pressure (IOP) measurement, Slit lamp biomicroscopy, Indirect
      ophthalmoscopy, Heidelberg Spectralis Spectral Domain Optical Coherence Tomography (SD-OCT)
      (no OCT for preoperative visit) and evaluation for systemic and ocular adverse events. Seven
      standard field photographs and Optos wide-field fluorescein angiography will be performed at
      postoperative visits at 4, 16, 28, 40,and 52 weeks. Humphrey visual field (HVF) testing (30-2
      and 60-4 test patterns) will be performed at postoperative visits at 4 and 52 weeks.
      Preoperative B scan echography will be required standard of care(SOC) to assess for macular
      traction, non-macular traction, retinal detachment and vitreous hemorrhage(VH).
      Identification of traction macular detachment will exclude the patient from the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: • Ocular and systemic safety evaluation for adverse events at any time point through 52 weeks:
time frame: Through 52 weeks from Baseline
description: Examples include worsened acuity >30 letters, rhegmatogenous or tractional retinal detachment, endophthalmitis, new or increased vitreous hemorrhage, cataract progression or surgery, need for additional vitrectomy or scleral buckle, development of new DME after OCT documentation of absence of DME, systemic thromboembolic events, deaths and systemic serious adverse events at any time point through week 52.
measure: Mean change in BCVA letter score
time frame: 52 weeks from Baseline
description: Mean change in BCVA letter score over time through week 52
measure: Mean BCVA letter score
time frame: 52 weeks from Baseline
description: Mean BCVA letter score over time through week 52
measure: Proportion of eyes with progression of PDR
time frame: Through 52 weeks from Baseline
description: Proportion of eyes with progression of PDR as defined above at any time point through week 52
measure: Mean OCT CSF thickness
time frame: Through 52 weeks from Baseline
description: Mean OCT CSF thickness over time through week 52
measure: Proportion of eyes with OCT CSF thickness <300um
time frame: Through 52 weeks from Baseline
description: Proportion of eyes with OCT CSF thickness <300um at week 52
measure: Proportion of eyes with absence of Optos widefield fluorescein angiographic macular leakage
time frame: Through 52 weeks from Baseline
description: Proportion of eyes with absence of Optos widefield fluorescein angiographic macular leakage at week 52
measure: Proportion of eyes with absence of active neovascularization
time frame: Through 52 weeks from Baseline
description: Proportion of eyes with absence of active neovascularization by Optos widefield fluorescein angiography at week 52
measure: Proportion of eyes with absence of active neovascularization
time frame: Through 52 weeks from Baseline
description: Proportion of eyes with absence of active neovascularization by 7 standard field photography at week 52
measure: Proportion of eyes with unchanged, worsened, or improved fluorescein angiographic macular leakage
time frame: Through 52 weeks from Baseline
description: Proportion of eyes with unchanged, worsened, or improved fluorescein angiographic macular leakage from baseline angiograms at week 52
measure: Proportion of eyes with unchanged, worsened, or improved fluorescein angiographic neovascularization
time frame: Through 52 weeks from Baseline
description: Proportion of eyes with unchanged, worsened, or improved fluorescein angiographic neovascularization from baseline angiograms at week 52
measure: Proportion of eyes with unchanged, worsened, or improved fundus photographic DME appearance
time frame: Through 52 weeks from Baseline
description: Proportion of eyes with unchanged, worsened, or improved fundus photographic DME appearance from baseline photographs at week 52
measure: Mean cumulative score and change for the combined 30-2 and 60-4 HVF test
time frame: Through 52 weeks from Baseline
description: Mean cumulative score and change for the combined 30-2 and 60-4 HVF test from week 4 to week 52.
measure: Proportion of eyes requiring additional IAI other than mandatory injections
time frame: Through 52 weeks from Baseline
description: Proportion of eyes requiring additional IAI other than mandatory injections through week 52
measure: Proportion of eye with progression of PDR requiring rescue PRP standard of care
time frame: Through 52 weeks from Baseline
description: Proportion of eye with progression of PDR requiring rescue PRP standard of care at any time point through 52 weeks
measure: Proportion of eyes requiring PRP or retinopexy
time frame: Through 52 weeks from Baseline
description: Proportion of eyes requiring PRP or retinopexy through week 52
measure: Proportion of eyes requiring additional vitrectomy
time frame: Through 52 weeks from Baseline
description: Proportion of eyes requiring additional vitrectomy through week 52
measure: Proportion of enrolled eyes requiring intraoperative endolaser in a PRP pattern at the time of initial vitrectomy
time frame: Through 52 weeks from Baseline
description: Proportion of enrolled eyes requiring intraoperative endolaser in a PRP pattern at the time of initial vitrectomy
arm group label: IAI q8 week Group
arm group type: Active Comparator
description: Eyes will be randomized on the day of endolaserless vitrectomy surgery or first postoperative 1-2 week visit to a group ("q8 week Group") where 4 additional mandatory postoperative q4weeks IAI followed by mandatory q8 weeks IAI for 52 weeks follow-up. Starting at week 20 in the q8week group eyes may be eligible to receive additional 2mg IAI (intravitreal aflibercept) (monthly) treatment
arm group label: IAI q16 week Group
arm group type: Active Comparator
description: Eyes will be randomized on the day of endolaserless vitrectomy surgery or first postoperative 1-2 week visit to a group (q16week Group) where 2 additional mandatory postoperative q4weeks IAI will be followed by mandatory q16weeks IAI for 52 weeks follow-up. Starting at week 12 in the q16 group, eyes may be eligible to receive additional 2mg IAI (intravitreal aflibercept) (monthly) treatment.
intervention type: Drug
intervention name: Aflibercept
description: . Study eyes will receive one preoperative intravitreal aflibercept injection (IAI) <21 days prior to vitrectomy and one intraoperative intravitreal aflibercept at end of surgery. Eyes will be randomized on the day of surgery or 1-2 weeks post-operatively to either a q8week IAI dosing regimen group or a q16week IAI dosing regimen group.
arm group label: IAI q16 week Group
arm group label: IAI q8 week Group
other name: Eylea
other name: 2 mg/0.05 mL single use vial for intravitreal injection
intervention type: Procedure
intervention name: Endolaserless Vitrectomy
description: Endolaserless vitrectomy and intraoperative and postoperative IAI in patients with PDR-related vitreous hemorrhage
arm group label: IAI q16 week Group
arm group label: IAI q8 week Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Dennis M Marcus, MD
role: Principal Investigator
affiliation: Southeast Retina Center, PC
last name: Dennis M Marcus, MD
phone: 706-650-0061
email: dmarcus@southeastretina.com
last name: Siobhan Ortiz
phone: 706-650-0061
email: siobhan@southeastretina.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Southeast Retina Center, Georgia
investigator full name: Dennis M. Marcus, M.D.
investigator title: Principal Investigator
mesh term: Retinal Diseases
mesh term: Diabetic Retinopathy
mesh term: Vitreous Hemorrhage
mesh term: Aflibercept
sharing ipd: Undecided