Use of Intravitreal Aflibercept Injection for Neovascular Glaucoma

NCT ID: NCT01711879

Last Updated: 2022-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-10-31

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.

Conditions

Neovascular Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Aflibercept

Intervention Type: DRUG

Details covered in arm description

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.

Group Type: EXPERIMENTAL

Aflibercept

Intervention Type: DRUG

Details covered in arm description

Interventions

Aflibercept

Details covered in arm description

Intervention Type: DRUG

Other Intervention Names

Eylea

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Malik Y Kahook, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Rocky Mountain Lions Eye Institute

Aurora, Colorado, United States

Countries

United States

Other Identifiers

12-1526

Identifier Type: -

Identifier Source: org_study_id