Use of Intravitreal Aflibercept Injection for Neovascular Glaucoma



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:21 - 90
Updated:10/14/2017
Start Date:January 2013
End Date:October 2015

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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).

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.

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
We found this trial at
2
sites
Aurora, Colorado 80045
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Aurora, CO
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Aurora, Colorado 80045
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Aurora, CO
Click here to add this to my saved trials