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

Sponsor
LEANDRO CABRAL ZACHARIAS (Other)
Overall Status
Unknown status
CT.gov ID
NCT02914626
Collaborator
Novartis (Industry)
28
Enrollment
2
Arms
24
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Intravitreal ranibizumab
 Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Intravitreal Ranibizumab (Lucentis®) for Neovascular Glaucoma- a Randomized Controlled Study
Study Start Date :
Oct 1, 2016
Anticipated Primary Completion Date :
Oct 1, 2017
Anticipated Study Completion Date :
Oct 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ranibizumab

Standard of care therapy plus intravitreal ranibizumab injections

Drug: Intravitreal ranibizumab
Intravitreal ranibizumab injection
Other Names:
  • Lucentis

    		•
    Sham Comparator: Control

    Standard of care therapy

    Drug: Intravitreal ranibizumab
    Intravitreal ranibizumab injection
    Other Names:
  • Lucentis

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Intraocular pressure [6 months]

    Secondary Outcome Measures

    1. Anterior segment neovascularization [6 months]

    2. Best corrected visual acuity [6 months]

    3. Number of drugs needed for IOP control [6 months]

    4. Need for IOP control surgery [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • LEANDRO CABRAL ZACHARIAS
    • Novartis

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    LEANDRO CABRAL ZACHARIAS, Attending - Department of Ophthalmology- University of Sao Paulo, University of Sao Paulo General Hospital
    ClinicalTrials.gov Identifier:
    NCT02914626
    Other Study ID Numbers:
    • USaoPauloGH 294.326
    First Posted:
    Sep 26, 2016
    Last Update Posted:
    Sep 27, 2016
    Last Verified:
    Sep 1, 2016
    Keywords provided by LEANDRO CABRAL ZACHARIAS, Attending - Department of Ophthalmology- University of Sao Paulo, University of Sao Paulo General Hospital
    Glaucoma, Neovascular
    Ranibizumab
    Intraocular pressure
    anti-VEGF
    intravitreal injection
    Additional relevant MeSH terms:
    Glaucoma
    Glaucoma, Neovascular
    Ranibizumab

    Study Results

    No Results Posted as of Sep 27, 2016