N/A N=7 Randomized Treatment

Use of Intravitreal Aflibercept Injection for Neovascular Glaucoma

Neovascular Glaucoma

Bottom Line

View on ClinicalTrials.gov: NCT01711879 ↗

Enrolled (actual)

Serious AEs

14.3%

Results posted

Jan 2021

Primary outcome: Primary: Incidence of Adverse Events — 3; 4 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Aflibercept (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: University of Colorado, Denver
Primary completion: Oct 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Adverse Events	3; 4	—
PRIMARY Severity of Adverse Events	0; 1; 0; 0; 0; 0	—
SECONDARY Rate and Extent of Resolution of Neovascularization	—	—
SECONDARY Intraocular Pressure (mmHg) at Baseline	10; 23.5; 11; 22.75	—
SECONDARY Intraocular Pressure (mmHg) at Week 52	10; 15.25; 10; 14	—
SECONDARY Number of Patients Losing > 5 Letters on Visual Acuity in Each Group A and Group B	0; 0	—
SECONDARY Number of Patients in Each, Group A and Group B, Gaining > 5 Letters on Visual Acuity	2; 0	—
SECONDARY Visual Acuity at Baseline	64; 37.5	—
SECONDARY Visual Acuity at Week 52	33.5; 62; 32; 46.75	—
SECONDARY Comparison of the Visual Field Between Groups	—	—
SECONDARY Measure of the Optical Coherence Tomography(OCT) Outcomes	—	—
SECONDARY Number of Patients With Need for Surgical Intervention	0; 0	—
SECONDARY Number of Participants With Need for Additional IOP Lowering Medications	0; 0	—
SECONDARY Extent of Resolution of Neovascularization Between Groups	—	—
SECONDARY Evaluation of the Average Retinal Nerve Fiber Layer (RNFL)	—	—

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).

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01711879). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.