Use of Intravitreal Aflibercept Injection for Neovascular Glaucoma
Primary Purpose
Neovascular Glaucoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aflibercept
Sponsored by
About this trial
This is an interventional treatment trial for Neovascular Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Patients with a diagnosis of neovascular glaucoma (Stage I-II)
- Individuals who are ages 21-90 years old; male or female of any race
- Presence of neovascularization of the iris and/or angle
- At least 90 degrees of "unzipped" anterior chamber angle as noted by gonioscopy. (a "zipped angle is the term used for a drainage angle that is slowly closing due to scar tissue from the neovascularization process)
- Visual acuity of light perception or better in the study eye
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
Exclusion Criteria:
- Use of intravitreal anti-VEGF agents in the study eye in the past 3 months.
- Full PRP in the study eye
- Prior vitrectomy in the study eye
- Prior trabeculectomy or other filtration surgery in the study eye
- Active ocular or periocular infection in the study eye
- Ocular conditions (Cataract or vitreous hemorrhage) that might require surgery in next 12 months
- Allergy to fluorescein dye
- Any past use of systemic anti-VEGF medication
- Myocardial infarction within 6 months prior to study enrollment
- Stroke within 6 months prior to study enrollment
- Pregnant or breast-feeding women
- Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study
Sites / Locations
- Rocky Mountain Lions Eye Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Aflibercept with Laser
Aflibercept
Arm Description
A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks
2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
Outcomes
Primary Outcome Measures
Incidence of Adverse Events
Assess the safety profile of repeated intravitreal aflibercept injections in patients with NVG by evaluating the incidence of adverse events
Severity of Adverse Events
Assess the safety profile of repeated intravitreal aflibercept injections in patients with NVG by evaluating the severity of adverse events
Secondary Outcome Measures
Rate and Extent of Resolution of Neovascularization
Compare between Groups A and B the Rate and extent of resolution of neovascularization in patients with NVG Stages 1 & 2.
Intraocular Pressure (mmHg) at Baseline
Intraocular pressure(mmHg) as measured by Goldmann applanation tonometry between groups A and B
Intraocular Pressure (mmHg) at Week 52
Mean intraocular pressure(mmHg) as measured by Goldmann applanation tonometry between groups A and B
Number of Patients Losing > 5 Letters on Visual Acuity in Each Group A and Group B
Comparison between patients, groups A and B, that lost > 5 letters on visual acuity
Number of Patients in Each, Group A and Group B, Gaining > 5 Letters on Visual Acuity
Comparison of patients in each, group A and group B, that gained > 5 letters on visual acuity
Visual Acuity at Baseline
Comparison of visual acuity between groups A and B
Visual Acuity at Week 52
Comparison of visual acuity at Week 52 between groups A and B
Comparison of the Visual Field Between Groups
Comparison of the Visual field s measured by HVF 24-2 SITA Standards between groups A and B
Measure of the Optical Coherence Tomography(OCT) Outcomes
Evaluation of the Optical Coherence Tomography(OCT) outcomes (average retinal nerve fiber layer(RNFL) and central macular thickness), Compared between groups A and B.
Number of Patients With Need for Surgical Intervention
Comparison between groups A and B and the need for surgical intervention in both arms during the follow-up period
Number of Participants With Need for Additional IOP Lowering Medications
Comparison between groups A and B for the need of additional IOP lowering medications
Extent of Resolution of Neovascularization Between Groups
Comparison of groups A and B and the extent of resolution of neovascularization in patients with NVG Stages 1 & 2
Evaluation of the Average Retinal Nerve Fiber Layer (RNFL)
Comparison between groups A and B of the average retinal nerve fiber layer (RNFL) as measured by Optical Coherence Tomography (OCT)
Full Information
NCT ID
NCT01711879
First Posted
October 18, 2012
Last Updated
February 16, 2022
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT01711879
Brief Title
Use of Intravitreal Aflibercept Injection for Neovascular Glaucoma
Official Title
Use of Intravitreal Aflibercept Injection for Neovascular Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This 52 week study will assess the use of intravitreal aflibercept injections in patients with neovascular glaucoma (NVG) compared to standard of care panretinal photocoagulation.
The investigators hypothesize that the neovascularization of the iris and angle present in neovascular glaucoma will resolve more quickly in eye treated with intravitreal aflibercept injection alone and result in increased comfort and preservation of visual field as compared to current standard of care utilizing pan-retinal photocoagulation. The advantages to intravitreal aflibercept injection use could include resolution of NVI/NVA (neovascularization of the iris/neovascularization of the angle) leading to quicker pain relief and quicker lowering of IOP (intraocular pressure).
Detailed Description
The two arms of this study will compare current common practice (initial intravitreal anti-VEGF (vascular endothelial growth factor) to study treatment (VEGF) injection only) for 52 weeks.
This single center study will consist of 20 patients with NVG. Patients will be randomized to:
Group A: A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks.
or
Group B: 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
Clinical assessment will include pain assessment (Universal Pain Scale), best corrected visual acuity (ETDRS), ophthalmic examination, anterior segment assessment including number of clock-hours of NVI/NVA, gonioscopy, anterior segment photography, visual field test (Humphrey SITA- Standard 24-2), optic nerve OCT (Zeiss Cirrus Optic Disc Cube 200x200), macular OCT (Cube scan 512 x 128 and 5 Line Raster), fluorescein angiography (initial iris phase followed by standard retinal angiography), and concurrent medical/ocular medications. Qualitative assessment of neovascularization will be made by the investigator based on comparison to baseline angiography.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aflibercept with Laser
Arm Type
Active Comparator
Arm Description
A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks
Arm Title
Aflibercept
Arm Type
Experimental
Arm Description
2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Aflibercept
Other Intervention Name(s)
Eylea
Intervention Description
Details covered in arm description
Primary Outcome Measure Information:
Title
Incidence of Adverse Events
Description
Assess the safety profile of repeated intravitreal aflibercept injections in patients with NVG by evaluating the incidence of adverse events
Time Frame
2 year
Title
Severity of Adverse Events
Description
Assess the safety profile of repeated intravitreal aflibercept injections in patients with NVG by evaluating the severity of adverse events
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Rate and Extent of Resolution of Neovascularization
Description
Compare between Groups A and B the Rate and extent of resolution of neovascularization in patients with NVG Stages 1 & 2.
Time Frame
1 year
Title
Intraocular Pressure (mmHg) at Baseline
Description
Intraocular pressure(mmHg) as measured by Goldmann applanation tonometry between groups A and B
Time Frame
Baseline
Title
Intraocular Pressure (mmHg) at Week 52
Description
Mean intraocular pressure(mmHg) as measured by Goldmann applanation tonometry between groups A and B
Time Frame
Week 52
Title
Number of Patients Losing > 5 Letters on Visual Acuity in Each Group A and Group B
Description
Comparison between patients, groups A and B, that lost > 5 letters on visual acuity
Time Frame
Baseline to Week 52
Title
Number of Patients in Each, Group A and Group B, Gaining > 5 Letters on Visual Acuity
Description
Comparison of patients in each, group A and group B, that gained > 5 letters on visual acuity
Time Frame
Baseline to Week 52
Title
Visual Acuity at Baseline
Description
Comparison of visual acuity between groups A and B
Time Frame
Baseline
Title
Visual Acuity at Week 52
Description
Comparison of visual acuity at Week 52 between groups A and B
Time Frame
Week 52
Title
Comparison of the Visual Field Between Groups
Description
Comparison of the Visual field s measured by HVF 24-2 SITA Standards between groups A and B
Time Frame
1 year
Title
Measure of the Optical Coherence Tomography(OCT) Outcomes
Description
Evaluation of the Optical Coherence Tomography(OCT) outcomes (average retinal nerve fiber layer(RNFL) and central macular thickness), Compared between groups A and B.
Time Frame
Baseline to Week 52
Title
Number of Patients With Need for Surgical Intervention
Description
Comparison between groups A and B and the need for surgical intervention in both arms during the follow-up period
Time Frame
1 year
Title
Number of Participants With Need for Additional IOP Lowering Medications
Description
Comparison between groups A and B for the need of additional IOP lowering medications
Time Frame
1 year
Title
Extent of Resolution of Neovascularization Between Groups
Description
Comparison of groups A and B and the extent of resolution of neovascularization in patients with NVG Stages 1 & 2
Time Frame
1 year
Title
Evaluation of the Average Retinal Nerve Fiber Layer (RNFL)
Description
Comparison between groups A and B of the average retinal nerve fiber layer (RNFL) as measured by Optical Coherence Tomography (OCT)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with a diagnosis of neovascular glaucoma (Stage I-II)
Individuals who are ages 21-90 years old; male or female of any race
Presence of neovascularization of the iris and/or angle
At least 90 degrees of "unzipped" anterior chamber angle as noted by gonioscopy. (a "zipped angle is the term used for a drainage angle that is slowly closing due to scar tissue from the neovascularization process)
Visual acuity of light perception or better in the study eye
Willing and able to comply with clinic visits and study-related procedures
Provide signed informed consent
Exclusion Criteria:
Use of intravitreal anti-VEGF agents in the study eye in the past 3 months.
Full PRP in the study eye
Prior vitrectomy in the study eye
Prior trabeculectomy or other filtration surgery in the study eye
Active ocular or periocular infection in the study eye
Ocular conditions (Cataract or vitreous hemorrhage) that might require surgery in next 12 months
Allergy to fluorescein dye
Any past use of systemic anti-VEGF medication
Myocardial infarction within 6 months prior to study enrollment
Stroke within 6 months prior to study enrollment
Pregnant or breast-feeding women
Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malik Y Kahook, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rocky Mountain Lions Eye Institute
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of Intravitreal Aflibercept Injection for Neovascular Glaucoma
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