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Intravitreal Ranibizumab (Lucentis®) for Neovascular Glaucoma- a Randomized Controlled Study

Primary Purpose

Glaucoma, Neovascular, Ranibizumab

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Intravitreal ranibizumab
Sponsored by
LEANDRO CABRAL ZACHARIAS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Neovascular focused on measuring Glaucoma, Neovascular, Ranibizumab, Intraocular pressure, anti-VEGF, intravitreal injection

Eligibility Criteria

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

Inclusion Criteria:

  • IOP greater than 24 mmHg
  • Iris or anterior chamber neovascularization
  • At least 120 degrees of opened anterior chamber angle

Exclusion Criteria:

  • Visual acuity worse than counting fingers in the fellow eye
  • No light perception in the treated eye
  • Any ocular infectious disease
  • Use of systemic steroids
  • Lack of media transparency precluding laser photocoagulation
  • Thromboembolic disease
  • Known hypersensitivity to ranibizumab
  • Female participants at childbearing age not using oral contraceptives
  • Use of intravitreal anti-VEGF over the last 30 days.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Ranibizumab

    Control

    Arm Description

    Standard of care therapy plus intravitreal ranibizumab injections

    Standard of care therapy

    Outcomes

    Primary Outcome Measures

    Intraocular pressure

    Secondary Outcome Measures

    Anterior segment neovascularization
    Best corrected visual acuity
    Number of drugs needed for IOP control
    Need for IOP control surgery

    Full Information

    First Posted
    September 22, 2016
    Last Updated
    September 24, 2016
    Sponsor
    LEANDRO CABRAL ZACHARIAS
    Collaborators
    Novartis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02914626
    Brief Title
    Intravitreal Ranibizumab (Lucentis®) for Neovascular Glaucoma- a Randomized Controlled Study
    Official Title
    Intravitreal Ranibizumab (Lucentis®) for Neovascular Glaucoma- a Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2016 (undefined)
    Primary Completion Date
    October 2017 (Anticipated)
    Study Completion Date
    October 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    LEANDRO CABRAL ZACHARIAS
    Collaborators
    Novartis

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Neovascular glaucoma is a potentially blinding condition characterized by the growth of newvessels at the anterior part of the eye. This growth is driven by the overexpression of a protein called Vascular Endothelial Growth Factor (VEGF). That happens in diseases such as diabetic retinopathy or venous retinal occlusion, and lead to a fast increase in intraocular pressure (IOP). Traditional treatment include laser photocoagulation of the retina in order to decrease VEGF formation. The investigators postulate that the use of anti-VEGF intravitreal injections may accelerate recovery and decrease the need of surgery in cases of neovascular glaucoma.
    Detailed Description
    This is a prospective, randomized controlled study that aims to evaluate the efficacy of ranibizumab (Lucentis®) as an adjunct in the treatment of patients with neovascular glaucoma. 28 patients with neovascular glaucoma (14 in the study group and 14 in the control standard of care group) will be recruited at a single center- University of Sao Paulo Medical School General Hospital. A complete ophthalmologic exam will be carried out, including the obtention of an informed consent for eligible patients willing to participate on the study. Patients will be randomly assigned to either standard of care- retinal laser photocoagulation and clinical management of intraocular pressure with drops, or standard of care plus intravitreal ranibizumab injections. Two injections will be performed 30 days apart. The patients will be followed for 6 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma, Neovascular, Ranibizumab
    Keywords
    Glaucoma, Neovascular, Ranibizumab, Intraocular pressure, anti-VEGF, intravitreal injection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    28 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ranibizumab
    Arm Type
    Experimental
    Arm Description
    Standard of care therapy plus intravitreal ranibizumab injections
    Arm Title
    Control
    Arm Type
    Sham Comparator
    Arm Description
    Standard of care therapy
    Intervention Type
    Drug
    Intervention Name(s)
    Intravitreal ranibizumab
    Other Intervention Name(s)
    Lucentis
    Intervention Description
    Intravitreal ranibizumab injection
    Primary Outcome Measure Information:
    Title
    Intraocular pressure
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Anterior segment neovascularization
    Time Frame
    6 months
    Title
    Best corrected visual acuity
    Time Frame
    6 months
    Title
    Number of drugs needed for IOP control
    Time Frame
    6 months
    Title
    Need for IOP control surgery
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: IOP greater than 24 mmHg Iris or anterior chamber neovascularization At least 120 degrees of opened anterior chamber angle Exclusion Criteria: Visual acuity worse than counting fingers in the fellow eye No light perception in the treated eye Any ocular infectious disease Use of systemic steroids Lack of media transparency precluding laser photocoagulation Thromboembolic disease Known hypersensitivity to ranibizumab Female participants at childbearing age not using oral contraceptives Use of intravitreal anti-VEGF over the last 30 days.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Leandro C Zacharias, MD, PhD
    Phone
    5511-2661-7871
    Email
    lczacharias@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

    Intravitreal Ranibizumab (Lucentis®) for Neovascular Glaucoma- a Randomized Controlled Study

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