Use of Intravitreal Aflibercept Injection for Neovascular Glaucoma

NCT01711879 | Completed Results

• 1 other identifier: 12-1526
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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).

Conditions

Neovascular Glaucoma

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (13)

• Rate and Extent of Resolution of Neovascularization

  1 year

• Intraocular Pressure (mmHg) at Baseline

  Baseline

• Intraocular Pressure (mmHg) at Week 52

  Week 52

• Number of Patients Losing > 5 Letters on Visual Acuity in Each Group A and Group B

  Baseline to Week 52

• Number of Patients in Each, Group A and Group B, Gaining > 5 Letters on Visual Acuity

  Baseline to Week 52

Study Arms (2)

Aflibercept with Laser

ACTIVE COMPARATOR

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

Drug: Aflibercept

Aflibercept

EXPERIMENTAL

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.

Drug: Aflibercept

Interventions

Aflibercept DRUG

Details covered in arm description

Also known as: Eylea

Aflibercept; Aflibercept with Laser

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Rocky Mountain Lions Eye Institute

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Glaucoma, Neovascular

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Results Point of Contact

• Title: Rachel Gerle
• Organization: University of Colorado School of Medicine

rachel.gerle@ucdenver.edu

720-848-2020

Study Officials

• Malik Y Kahook, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2012
• First Posted: October 22, 2012
• Study Start: January 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: March 18, 2022
• Results First Posted: January 5, 2021

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)