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

October 18, 2012
January 29, 2013
January 2013
June 2014   (final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT01711879 on ClinicalTrials.gov Archive Site
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
Not Provided
Not Provided
Not Provided
 
Use of Intravitreal Aflibercept Injection for Neovascular Glaucoma
Use of Intravitreal Aflibercept Injection for Neovascular Glaucoma

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Neovascular Glaucoma
Drug: Aflibercept
Details covered in arm description
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
21 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01711879
12-1526
No
University of Colorado, Denver
University of Colorado, Denver
Not Provided
Principal Investigator: Malik Y Kahook, MD University of Colorado, Denver
University of Colorado, Denver
January 2013

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