Use of Intravitreal Aflibercept Injection for Neovascular Glaucoma

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).

Study Overview

• Status: Completed
• Conditions: Neovascular Glaucoma
• Intervention / Treatment: Drug: Aflibercept

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Rocky Mountain Lions Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aflibercept with Laser; 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	Drug: Aflibercept; Details covered in arm description; Other Names: Eylea
Experimental: Aflibercept; 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.	Drug: Aflibercept; Details covered in arm description; Other Names: Eylea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events	Assess the safety profile of repeated intravitreal aflibercept injections in patients with NVG by evaluating the incidence of adverse events	2 year
Severity of Adverse Events	Assess the safety profile of repeated intravitreal aflibercept injections in patients with NVG by evaluating the severity of adverse events	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year
Intraocular Pressure (mmHg) at Baseline	Intraocular pressure(mmHg) as measured by Goldmann applanation tonometry between groups A and B	Baseline
Intraocular Pressure (mmHg) at Week 52	Mean intraocular pressure(mmHg) as measured by Goldmann applanation tonometry between groups A and B	Week 52
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	Baseline to Week 52
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	Baseline to Week 52
Visual Acuity at Baseline	Comparison of visual acuity between groups A and B	Baseline
Visual Acuity at Week 52	Comparison of visual acuity at Week 52 between groups A and B	Week 52
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	1 year
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.	Baseline to Week 52
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	1 year
Number of Participants With Need for Additional IOP Lowering Medications	Comparison between groups A and B for the need of additional IOP lowering medications	1 year
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	1 year
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)	1 year

Collaborators and Investigators

• Sponsor: University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: October 18, 2012
• First Submitted That Met QC Criteria: October 19, 2012
• First Posted (Estimate): October 22, 2012

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Neovascular; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: 12-1526

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No