Use of Intravitreal Aflibercept Injection for Neovascular Glaucoma

Neovascular Glaucoma Clinical Trial

Official title:

Use of Intravitreal Aflibercept Injection for Neovascular Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01711879
• Other study ID #: 12-1526
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: October 2015

Study information

• Verified date: February 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Neovascular
• Neovascular Glaucoma

Intervention

Drug:
• Aflibercept
Details covered in arm description

Locations

Country	Name	City	State
United States	Rocky Mountain Lions Eye Institute	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Intraocular Pressure (mmHg) at Baseline	Intraocular pressure(mmHg) as measured by Goldmann applanation tonometry between groups A and B	Baseline
Secondary	Intraocular Pressure (mmHg) at Week 52	Mean intraocular pressure(mmHg) as measured by Goldmann applanation tonometry between groups A and B	Week 52
Secondary	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
Secondary	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
Secondary	Visual Acuity at Baseline	Comparison of visual acuity between groups A and B	Baseline
Secondary	Visual Acuity at Week 52	Comparison of visual acuity at Week 52 between groups A and B	Week 52
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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