Clinical Trial: Use of Intravitreal Aflibercept Injection for Neovascular Glaucoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 (neovascularization of the iris/neovascularization of the angle) leading to quicker pain relief and quicker lowering of IOP (intraocular pressure).


Detailed Summary:

The two arms of this study will compare current common practice (initial intravitreal anti-VEGF (vascular endothelial growth factor) to study treatment (VEGF) injection only) for 52 weeks.

This single center study will consist of 20 patients with NVG. Patients will be randomized to:

  • Group A: 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.

or

  • Group B: 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.

Clinical assessment will include pain assessment (Universal Pain Scale), best corrected visual acuity (ETDRS), ophthalmic examination, anterior segment assessment including number of clock-hours of NVI/NVA, gonioscopy, anterior segment photography, visual field test (Humphrey SITA- Standard 24-2), optic nerve OCT (Zeiss Cirrus Optic Disc Cube 200x200), macular OCT (Cube scan 512 x 128 and 5 Line Raster), fluorescein angiography (initial iris phase followed by standard retinal angiography), and concurrent medical/ocular medications. Qualitative assessment of neovascularization will be made by the investigator based on comparison to baseline angiography.


Sponsor: University of Colorado, Denver

Current Primary Outcome: Incidence and Severity of Adverse Events [ Time Frame: 1 year ]

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:

Current Secondary Outcome: Comparison Between Groups [ Time Frame: 1 year ]

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:

Information By: University of Colorado, Denver

Dates:
Date Received: October 18, 2012
Date Started: January 2013
Date Completion:
Last Updated: January 20, 2017
Last Verified: January 2017