Rocky Mountain Lions Eye Institute
Aurora, Colorado, 80045, United States
NCT Number: NCT01711879
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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Notify Me21 year–90 year
All sexes
Interventional
Not applicable
Aurora, Colorado, 80045, United States
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:
or
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Details covered in arm description
Other names: Eylea
Time frame: 2 year
Assess the safety profile of repeated intravitreal aflibercept injections in patients with NVG by evaluating the incidence 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
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.
Time frame: Baseline
Intraocular pressure(mmHg) as measured by Goldmann applanation tonometry between groups A and B
Time frame: Week 52
Mean intraocular pressure(mmHg) as measured by Goldmann applanation tonometry between groups A and B
Time frame: Baseline to Week 52
Comparison between patients, groups A and B, that lost > 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
Time frame: Baseline
Comparison of visual acuity between groups A and B
Time frame: Week 52
Comparison of visual acuity at Week 52 between groups A and B
Time frame: 1 year
Comparison of the Visual field s measured by HVF 24-2 SITA Standards between groups A and B
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.
Time frame: 1 year
Comparison between groups A and B and the need for surgical intervention in both arms during the follow-up period
Time frame: 1 year
Comparison between groups A and B for the need of additional IOP lowering medications
Time frame: 1 year
Comparison of groups A and B and the extent of resolution of neovascularization in patients with NVG Stages 1 & 2
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)
University of Colorado, Denver
Other
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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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