Use of Intravitreal Aflibercept Injection for Neovascular Glaucoma

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT01711879

First received: October 18, 2012

Last updated: January 29, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

October 18, 2012

Last Updated Date

January 29, 2013

Start Date ^ICMJE

January 2013

Estimated Primary Completion Date

June 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Incidence and Severity of Adverse Events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Assess the safety profile of repeated intravitreal aflibercept injections in patients with NVG by evaluating the incidence and severity of adverse events

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01711879 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Comparison Between Groups [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Compare between Groups A and B

Rate and extent of resolution of neovascularization in patients with NVG Stages 1 & 2
Mean change in intraocular pressure(IOP) as measured by Goldmann applanation tonometry
Proportion of patients losing > 5 letters on visual acuity
Proportion of patients gaining ≥ 5 letters on visual acuity
Mean change in visual acuity
Visual field as measured by HVF 24-2 SITA Standards
Optical Coherence Tomography(OCT) outcomes (average retinal nerve fiber layer(RNFL) and central macular thickness)
Need for additional IOP lowering medications
Need for surgical intervention in both arms during the follow-up period

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Use of Intravitreal Aflibercept Injection for Neovascular Glaucoma

Official Title ^ICMJE

Use of Intravitreal Aflibercept Injection for Neovascular Glaucoma

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 leading to quicker pain relief and quicker lowering of IOP.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Neovascular Glaucoma

Intervention ^ICMJE

Drug: Aflibercept

Details covered in arm description

Study Arm (s)

Active Comparator: Aflibercept with Laser
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

Intervention: Drug: Aflibercept
Experimental: Aflibercept
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.

Intervention: Drug: Aflibercept

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2014

Estimated Primary Completion Date

June 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

21 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01711879

Other Study ID Numbers ^ICMJE

12-1526

Has Data Monitoring Committee

Responsible Party

University of Colorado, Denver

Study Sponsor ^ICMJE

University of Colorado, Denver

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Malik Y Kahook, MD

University of Colorado, Denver

Information Provided By

University of Colorado, Denver

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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