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Prognostic Factors for Visual Improvement in Patients Undergoing Intravitreal Ranibizumab for Retinal Vein Occlusion

Primary Purpose

Researcher-Subject Relations

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ranibizumab
Sponsored by
St. Marianna University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Researcher-Subject Relations

Eligibility Criteria

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

Inclusion Criteria:

  • Age ≥ 18, Patient of RVO, BCVA ≥ 0.1 (decimal visual acuity), Mean VRT≥ 250 μm
  • signed informed consent

Exclusion Criteria:

  • Laser photocoagulation for ME ≤ 4 months prior to initiation of this study therapy
  • Intraocular corticosteroid use ≤ 3 months prior to initiation of this study therapy
  • History of anti-VEGF treatment (intravitreal ≤3 months prior to initiation of this study therapy, systemic ≤ 6 months prior to initiation of this study therapy)
  • Stroke or myocardial infarction ≤ 3 months prior to initiation of this study
  • Pregnancy or potential pregnancy, and breastfeeding
  • Severe liver dysfunction, severe CKD/hemodialysis, uncontrolled DM (HbA1c>10), uncontrolled hypertension (BP≥ 160/100 mmHg)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Ranibizumab

    Arm Description

    Ranibizumab

    Outcomes

    Primary Outcome Measures

    Best-corrected visual acuity at 1 year after primary treatment

    Secondary Outcome Measures

    age, past medical history, complication (ex. Hypertension, Hyperlipidemia etc.), pretreatment BCVA, the photoreceptor outer segment (PROS) length, central foveal thickness (CFT), outer foveal thickness (OFT), and outer nuclear layer thickness (ONLT)

    Full Information

    First Posted
    March 22, 2014
    Last Updated
    August 24, 2017
    Sponsor
    St. Marianna University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02144662
    Brief Title
    Prognostic Factors for Visual Improvement in Patients Undergoing Intravitreal Ranibizumab for Retinal Vein Occlusion
    Official Title
    To Investigate Prognostic Factors for Visual Improvement in Patients Undergoing Intravitreal Ranibizumab for Retinal Vein Occlusion
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2014 (undefined)
    Primary Completion Date
    January 31, 2017 (Actual)
    Study Completion Date
    April 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    St. Marianna University School of Medicine

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Primary Objective: To investigate the pretreatment quantitative factors as shown in SD-OCT images that correlate with posttreatment VA in patients who underwent intravitreal Lucentis (Ranibizumab) for RVO. Secondary Objectives: Correlations between posttreatment BCVA and pretreatment factors were evaluated, including age, pretreatment BCVA, photoreceptor outer segment (PROS) length, central foveal thickness (CFT), outer foveal thickness (OFT), and outer nuclear layer thickness (ONLT). The factors influencing posttreatment BCVA were evaluated using multiple regression analysis. Detailed information on macular morphology, such as the photoreceptor IS/OS junction and ELM, can be obtained in SD-OCT. Some OCT studies evaluated other quantitative factors in eye disease. It was reported that PROS length was correlated with BCVA in patients with DME.¹ Other investigators suggested that the thickness, area, and volume of the outer layer were correlated with BCVA in patients with dry age-related macular degeneration (AMD).² Outer foveal thickness (OFT) and relative reflectivity of the outer nuclear layer (ONL) were associated with BCVA in patients with macular hole.3, 4 The volume of the ONL was found to be associated with BCVA in patients with AMD.5 The aim of this study was to investigate the pretreatment quantitative factors as shown in SD-OCT images that correlate with posttreatment VA in patients who underwent intravitreal Lucentis (Ranibizumab) for RVO.
    Detailed Description
    Detailed information on macular morphology, such as the photoreceptor IS/OS junction and ELM, can be obtained in SD-OCT. Some OCT studies evaluated other quantitative factors in eye disease. It was reported that PROS length was correlated with BCVA in patients with DME.¹ Other investigators suggested that the thickness, area, and volume of the outer layer were correlated with BCVA in patients with dry age-related macular degeneration (AMD).² OFT and relative reflectivity of the ONL were associated with BCVA in patients with macular hole.3, 4 The volume of the ONL was found to be associated with BCVA in patients with AMD.5 The aim of this study was to investigate the pretreatment quantitative factors as shown in SD-OCT images that correlate with posttreatment VA in patients who underwent intravitreal Lucentis (Ranibizumab) for RVO.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Researcher-Subject Relations

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ranibizumab
    Arm Type
    Experimental
    Arm Description
    Ranibizumab
    Intervention Type
    Drug
    Intervention Name(s)
    Ranibizumab
    Other Intervention Name(s)
    Lucentis
    Intervention Description
    0.5mg ranibizumab intravitreal injection
    Primary Outcome Measure Information:
    Title
    Best-corrected visual acuity at 1 year after primary treatment
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    age, past medical history, complication (ex. Hypertension, Hyperlipidemia etc.), pretreatment BCVA, the photoreceptor outer segment (PROS) length, central foveal thickness (CFT), outer foveal thickness (OFT), and outer nuclear layer thickness (ONLT)
    Time Frame
    baseline, 3months, 6months, 9month and 12months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 18, Patient of RVO, BCVA ≥ 0.1 (decimal visual acuity), Mean VRT≥ 250 μm signed informed consent Exclusion Criteria: Laser photocoagulation for ME ≤ 4 months prior to initiation of this study therapy Intraocular corticosteroid use ≤ 3 months prior to initiation of this study therapy History of anti-VEGF treatment (intravitreal ≤3 months prior to initiation of this study therapy, systemic ≤ 6 months prior to initiation of this study therapy) Stroke or myocardial infarction ≤ 3 months prior to initiation of this study Pregnancy or potential pregnancy, and breastfeeding Severe liver dysfunction, severe CKD/hemodialysis, uncontrolled DM (HbA1c>10), uncontrolled hypertension (BP≥ 160/100 mmHg)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jiro Kogo, M.D., Ph. D.
    Organizational Affiliation
    St. Marianna University School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Prognostic Factors for Visual Improvement in Patients Undergoing Intravitreal Ranibizumab for Retinal Vein Occlusion

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