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Completed

NCT Number: NCT01711879

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

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Key information

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rocky Mountain Lions Eye Institute

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aflibercept

Drug

Details covered in arm description

Other names: Eylea

Primary outcomes

  1. Incidence of Adverse Events

    Time frame: 2 year

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

  2. Severity of Adverse Events

    Time frame: 2 year

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

Secondary outcomes

  1. Rate and Extent of Resolution of Neovascularization

    Time frame: 1 year

    Compare between Groups A and B the Rate and extent of resolution of neovascularization in patients with NVG Stages 1 & 2.

  2. Intraocular Pressure (mmHg) at Baseline

    Time frame: Baseline

    Intraocular pressure(mmHg) as measured by Goldmann applanation tonometry between groups A and B

  3. Intraocular Pressure (mmHg) at Week 52

    Time frame: Week 52

    Mean intraocular pressure(mmHg) as measured by Goldmann applanation tonometry between groups A and B

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

    Time frame: Baseline to Week 52

    Comparison between patients, groups A and B, that lost > 5 letters on visual acuity

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

    Time frame: Baseline to Week 52

    Comparison of patients in each, group A and group B, that gained > 5 letters on visual acuity

  6. Visual Acuity at Baseline

    Time frame: Baseline

    Comparison of visual acuity between groups A and B

  7. Visual Acuity at Week 52

    Time frame: Week 52

    Comparison of visual acuity at Week 52 between groups A and B

  8. Comparison of the Visual Field Between Groups

    Time frame: 1 year

    Comparison of the Visual field s measured by HVF 24-2 SITA Standards between groups A and B

  9. Measure of the Optical Coherence Tomography(OCT) Outcomes

    Time frame: Baseline to Week 52

    Evaluation of the Optical Coherence Tomography(OCT) outcomes (average retinal nerve fiber layer(RNFL) and central macular thickness), Compared between groups A and B.

  10. Number of Patients With Need for Surgical Intervention

    Time frame: 1 year

    Comparison between groups A and B and the need for surgical intervention in both arms during the follow-up period

  11. Number of Participants With Need for Additional IOP Lowering Medications

    Time frame: 1 year

    Comparison between groups A and B for the need of additional IOP lowering medications

  12. Extent of Resolution of Neovascularization Between Groups

    Time frame: 1 year

    Comparison of groups A and B and the extent of resolution of neovascularization in patients with NVG Stages 1 & 2

  13. Evaluation of the Average Retinal Nerve Fiber Layer (RNFL)

    Time frame: 1 year

    Comparison between groups A and B of the average retinal nerve fiber layer (RNFL) as measured by Optical Coherence Tomography (OCT)

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 22, 2012
Registry last updated
Mar 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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