Clinical trial NCT01711879: Use of Intravitreal Aflibercept Injection for Neovascular Glaucoma
Official title: Use of Intravitreal Aflibercept Injection for Neovascular Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neovascular Glaucoma
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2012-10-22
Enrollment: 7
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: 2 year
measure: Severity of Adverse Events
timeFrame: 2 year
Secondary outcomes:
measure: Rate and Extent of Resolution of Neovascularization
timeFrame: 1 year
measure: Intraocular Pressure (mmHg) at Baseline
timeFrame: Baseline
measure: Intraocular Pressure (mmHg) at Week 52
timeFrame: Week 52
measure: Number of Patients Losing > 5 Letters on Visual Acuity in Each Group A and Group B
timeFrame: Baseline to Week 52
measure: Number of Patients in Each, Group A and Group B, Gaining > 5 Letters on Visual Acuity
timeFrame: Baseline to Week 52
measure: Visual Acuity at Baseline
timeFrame: Baseline
measure: Visual Acuity at Week 52
timeFrame: Week 52
measure: Comparison of the Visual Field Between Groups
timeFrame: 1 year
measure: Measure of the Optical Coherence Tomography(OCT) Outcomes
timeFrame: Baseline to Week 52
measure: Number of Patients With Need for Surgical Intervention
timeFrame: 1 year
measure: Number of Participants With Need for Additional IOP Lowering Medications
timeFrame: 1 year
measure: Extent of Resolution of Neovascularization Between Groups
timeFrame: 1 year
measure: Evaluation of the Average Retinal Nerve Fiber Layer (RNFL)
timeFrame: 1 year
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Lions Eye Institute
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Malik Y Kahook, MD
role: PRINCIPAL_INVESTIGATOR
References: