Use of Intravitreal Aflibercept Injection for Neovascular Glaucoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Colorado, Denver
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01711879
First received: October 18, 2012
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Neovascular Glaucoma
Drug: Aflibercept

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Intravitreal Aflibercept Injection for Neovascular Glaucoma

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 20
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Aflibercept
Details covered in arm description
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.
Drug: Aflibercept
Details covered in arm description

  Eligibility

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01711879

Contacts
Contact: Mary Preston 720-848-2035 mary.preston@ucdenver.edu
Contact: Malik Y Kahook, MD 720-848-2500 mary.preston@ucdenver.edu

Locations
United States, Colorado
Rocky Mountain Lions Eye Institute Recruiting
Aurora, Colorado, United States, 80045
Contact: Malik Y Kahook, MD    720-848-2500    malik.kahook@ucdenver.edu   
Contact: Mary Preston    720-848-2035    mary.preston@ucdenver.edu   
Principal Investigator: Malik Y Kahook, MD         
Sub-Investigator: Naresh Mandava, MD         
Sub-Investigator: Mina Pantcheva, MD         
Sub-Investigator: Leonard Seibold, MD         
Rocky Mountain Lions Eye Institute Recruiting
Aurora, Colorado, United States, 80045
Contact: Mary Preston    720-848-2035    Mary.preston@ucdenver.edu   
Principal Investigator: Malik Y Kahook, MD         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Malik Y Kahook, MD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01711879     History of Changes
Other Study ID Numbers: 12-1526
Study First Received: October 18, 2012
Last Updated: June 13, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Neovascular
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on July 28, 2014