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
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
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
NCT ID
NCT02914626
First Posted
September 22, 2016
Last Updated
September 24, 2016
Sponsor
LEANDRO CABRAL ZACHARIAS
Collaborators
Novartis
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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