Use of Intravitreal Aflibercept Injection for Neovascular Glaucoma

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Neovascular Glaucoma

Treatments: Drug: Aflibercept

Study type: Interventional

Funder types: Other

Identifiers

NCT01711879

12-1526

Details and patient eligibility

About

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).

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 21 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Aflibercept with Laser

Active Comparator group

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

Treatment:

Drug: Aflibercept

Aflibercept

Experimental group

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.

Treatment:

Drug: Aflibercept