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Evaluation of the "Treat-and-extend" Scheme in Patients With Retinal Vein Occlusion (RVO) With and Without LASER Treatment of Ischaemic Retinal Areas (PEARL)

Primary Purpose

Central Retinal Vein Occlusion With Macular Edema

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ranibizumab
Laser
Sponsored by
PD. Dr. med. Armin Wolf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Retinal Vein Occlusion With Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • retinal vein occlusion with OCT-diagnosed macular edema with a documented duration of 3 months or less
  • age over 18
  • documented maximal visual acuity of 0,5 ETDRS
  • voluntary participation in this study as proven by written informed consent
  • ability to follow study instructions and likely to attend and complete all required visits
  • pre-menopausal female patients with childbearing potential must use an approved contraceptive method (Pearl index <1)
  • pre-menopausal female patients with childbearing potential: a negative serum pregnancy test must be obtained prior to treatment start
  • ischemic area of more than 5 pupillary distance (PD) in angiography

Exclusion Criteria:

  • subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial
  • patients with known allergy to Ranibizumab or ingredients of the injection solution
  • treatment in another clinical trial with therapeutic intervention or use of any other investigational medicinal product (IMP) during the trial or within the 30 days before enrolment
  • known or persistent abuse of medication, drugs or alcohol
  • women who are pregnant or breast-feeding
  • failure of laboratory inclusion criteria
  • diabetic retinopathy
  • previous anti-VEGF (Lucentis ®, Avastin®, Eylea®) or LASER therapy due to RVO
  • previous intravitreal steroid therapy
  • status post excision of the vitreous body
  • status post intraocular surgery within 3 months before enrolment
  • established or suspected ocular or periocular infection
  • evidence of giant cell arteriitis
  • retinal hemorrhages that seem to prevent a Laser-treatment of ischemic areals within the following 12 weeks
  • unregulated hypertension above 200/120 mmHg
  • cerebral vascular occurence or myocardium infarct within 12 months before enrolment
  • relevant systemic diseases that might be associated with elevated VEGF serum concentration
  • active malignancies (status post successful treatment of malignancies is no exclusion criterion)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Ranibizumab

    Ranibizumab + Laser

    Arm Description

    Patients receive intravitreal injections of 0,5 mg Ranibizumab (Lucentis®) / injection following the "treat-and-extend" scheme for 12 months.

    Apart from receiving intravitreal injections of 0,5 mg Ranibizumab (Lucentis®) / injection following the "treat-and-extend" scheme for 12 months, patients receive a panretinal photocoagulation on visit 3 and / or 4.

    Outcomes

    Primary Outcome Measures

    Differences in the length of the treatment-free interval in patients with or without panretinal photocoagulation
    Length of the longest interval between reinjections that did not result in recurrence

    Secondary Outcome Measures

    Number of Injections
    Retinal thickness in µm measured by spectral domain (SD)-Optical coherence tomography (OCT) at end-of-study visit
    end-of-study visit is performed at individualized retreatment interval (can range from 4-9 weeks) after last injection within 12 months after first injection of Ranibizumab
    Visus at end-of-study visit
    end-of-study visit is performed at individualized retreatment interval (can range from 4-9 weeks) after last injection within 12 months after first injection of Ranibizumab
    Percentage of patients with retinal thickness of more than 220 µm in the OCT examination at the end-of-study visit
    end-of-study visit is performed at individualized retreatment interval (can range from 4-9 weeks) after last injection within 12 months after first injection of Ranibizumab

    Full Information

    First Posted
    August 4, 2015
    Last Updated
    August 11, 2015
    Sponsor
    PD. Dr. med. Armin Wolf
    Collaborators
    University Hospital, Bonn
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02522897
    Brief Title
    Evaluation of the "Treat-and-extend" Scheme in Patients With Retinal Vein Occlusion (RVO) With and Without LASER Treatment of Ischaemic Retinal Areas
    Acronym
    PEARL
    Official Title
    Evaluation of the "Treat-and-extend" Scheme in Patients With Retinal Vein Occlusion (RVO) With and Without LASER Treatment of Ischaemic Retinal Areas
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    January 2018 (Anticipated)
    Study Completion Date
    January 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    PD. Dr. med. Armin Wolf
    Collaborators
    University Hospital, Bonn

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine if additional panretinal photocoagulation of ischemic areas following retinal vein occlusion (RVO) may reduce the rate of recurrence and allow longer treatment intervals in anti-Vascular Endothelial Growth Factor (VEGF) treatment following the "trea-and-extend" scheme.
    Detailed Description
    Patients with macular edema following RVO receive an anti-VEGF treatment by injection of Ranibizumab for 12 months in the "treat-and-extend" scheme. Following this scheme, all patients receive a series of three injections at the interval of 4 weeks. Thereafter, the retreatment interval is determined by results of certain examinations. The next control including a reinjection is scheduled with an extension of one week until the patient presents signs of recurrence. Assuming that by the time of recurrence the interval is too long, the next control (following a retreatment) is then scheduled one week sooner than the last control. Following this treatment schedule, the individualized retreatment interval is thereafter kept steady. Half the patients receive an additional panretinal photocoagulation on visit 3 and / or 4. Aim of this study is to investigate if this additional panretinal photocoagulation may result in a longer individualized retreatment interval corresponding to a reduced rate of recurrence of macular edema.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Central Retinal Vein Occlusion With Macular Edema

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ranibizumab
    Arm Type
    Active Comparator
    Arm Description
    Patients receive intravitreal injections of 0,5 mg Ranibizumab (Lucentis®) / injection following the "treat-and-extend" scheme for 12 months.
    Arm Title
    Ranibizumab + Laser
    Arm Type
    Experimental
    Arm Description
    Apart from receiving intravitreal injections of 0,5 mg Ranibizumab (Lucentis®) / injection following the "treat-and-extend" scheme for 12 months, patients receive a panretinal photocoagulation on visit 3 and / or 4.
    Intervention Type
    Drug
    Intervention Name(s)
    Ranibizumab
    Other Intervention Name(s)
    Lucentis
    Intervention Type
    Device
    Intervention Name(s)
    Laser
    Other Intervention Name(s)
    Visulas 532s Laser
    Primary Outcome Measure Information:
    Title
    Differences in the length of the treatment-free interval in patients with or without panretinal photocoagulation
    Description
    Length of the longest interval between reinjections that did not result in recurrence
    Time Frame
    within 12 months after first injection of Ranibizumab
    Secondary Outcome Measure Information:
    Title
    Number of Injections
    Time Frame
    within 12 months after first injection of Ranibizumab
    Title
    Retinal thickness in µm measured by spectral domain (SD)-Optical coherence tomography (OCT) at end-of-study visit
    Description
    end-of-study visit is performed at individualized retreatment interval (can range from 4-9 weeks) after last injection within 12 months after first injection of Ranibizumab
    Time Frame
    4-9 weeks after last injection within
    Title
    Visus at end-of-study visit
    Description
    end-of-study visit is performed at individualized retreatment interval (can range from 4-9 weeks) after last injection within 12 months after first injection of Ranibizumab
    Time Frame
    4-9 weeks after last injection within
    Title
    Percentage of patients with retinal thickness of more than 220 µm in the OCT examination at the end-of-study visit
    Description
    end-of-study visit is performed at individualized retreatment interval (can range from 4-9 weeks) after last injection within 12 months after first injection of Ranibizumab
    Time Frame
    4-9 weeks after last injection within

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: retinal vein occlusion with OCT-diagnosed macular edema with a documented duration of 3 months or less age over 18 documented maximal visual acuity of 0,5 ETDRS voluntary participation in this study as proven by written informed consent ability to follow study instructions and likely to attend and complete all required visits pre-menopausal female patients with childbearing potential must use an approved contraceptive method (Pearl index <1) pre-menopausal female patients with childbearing potential: a negative serum pregnancy test must be obtained prior to treatment start ischemic area of more than 5 pupillary distance (PD) in angiography Exclusion Criteria: subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial patients with known allergy to Ranibizumab or ingredients of the injection solution treatment in another clinical trial with therapeutic intervention or use of any other investigational medicinal product (IMP) during the trial or within the 30 days before enrolment known or persistent abuse of medication, drugs or alcohol women who are pregnant or breast-feeding failure of laboratory inclusion criteria diabetic retinopathy previous anti-VEGF (Lucentis ®, Avastin®, Eylea®) or LASER therapy due to RVO previous intravitreal steroid therapy status post excision of the vitreous body status post intraocular surgery within 3 months before enrolment established or suspected ocular or periocular infection evidence of giant cell arteriitis retinal hemorrhages that seem to prevent a Laser-treatment of ischemic areals within the following 12 weeks unregulated hypertension above 200/120 mmHg cerebral vascular occurence or myocardium infarct within 12 months before enrolment relevant systemic diseases that might be associated with elevated VEGF serum concentration active malignancies (status post successful treatment of malignancies is no exclusion criterion)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Verena Dykstra, Dr.
    Phone
    +49 228 287 16360
    Email
    verena.dykstra@ukb.uni-bonn.de
    First Name & Middle Initial & Last Name or Official Title & Degree
    Almut Steinhagen, Dr.
    Phone
    +49 228 287 16029
    Email
    almut.steinhagen@ukb.uni-bonn.de
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Armin Wolf, PD Dr.
    Organizational Affiliation
    Eye Clinic of the Ludwig Maximilians University of Munich
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of the "Treat-and-extend" Scheme in Patients With Retinal Vein Occlusion (RVO) With and Without LASER Treatment of Ischaemic Retinal Areas

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