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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aflibercept with Laser | Active Comparator | 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 |
|
| Aflibercept | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept | Drug | Details covered in arm description |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Assess the safety profile of repeated intravitreal aflibercept injections in patients with NVG by evaluating the incidence of adverse events | 2 year |
| Severity of Adverse Events | Assess the safety profile of repeated intravitreal aflibercept injections in patients with NVG by evaluating the severity of adverse events | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Rate and Extent of Resolution of Neovascularization | Compare between Groups A and B the Rate and extent of resolution of neovascularization in patients with NVG Stages 1 & 2. | 1 year |
| Intraocular Pressure (mmHg) at Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Malik Y Kahook, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Lions Eye Institute | Aurora | Colorado | 80045 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Aflibercept: Details covered in arm description |
| BG001 | Aflibercept |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Adverse Events | Assess the safety profile of repeated intravitreal aflibercept injections in patients with NVG by evaluating the incidence of adverse events | Posted | Count of Participants | Participants | 2 year |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Recurrent BCC | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Gerle | University of Colorado School of Medicine | 720-848-2020 | rachel.gerle@ucdenver.edu |
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| ID | Term |
|---|---|
| D015355 | Glaucoma, Neovascular |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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Intraocular pressure(mmHg) as measured by Goldmann applanation tonometry between groups A and B
| Baseline |
| Intraocular Pressure (mmHg) at Week 52 | Mean intraocular pressure(mmHg) as measured by Goldmann applanation tonometry between groups A and B | Week 52 |
| Number of Patients Losing > 5 Letters on Visual Acuity in Each Group A and Group B | Comparison between patients, groups A and B, that lost > 5 letters on visual acuity | Baseline to Week 52 |
| Number of Patients in Each, Group A and Group B, Gaining > 5 Letters on Visual Acuity | Comparison of patients in each, group A and group B, that gained > 5 letters on visual acuity | Baseline to Week 52 |
| Visual Acuity at Baseline | Comparison of visual acuity between groups A and B | Baseline |
| Visual Acuity at Week 52 | Comparison of visual acuity at Week 52 between groups A and B | Week 52 |
| Comparison of the Visual Field Between Groups | Comparison of the Visual field s measured by HVF 24-2 SITA Standards between groups A and B | 1 year |
| Measure of the Optical Coherence Tomography(OCT) Outcomes | Evaluation of the Optical Coherence Tomography(OCT) outcomes (average retinal nerve fiber layer(RNFL) and central macular thickness), Compared between groups A and B. | Baseline to Week 52 |
| Number of Patients With Need for Surgical Intervention | Comparison between groups A and B and the need for surgical intervention in both arms during the follow-up period | 1 year |
| Number of Participants With Need for Additional IOP Lowering Medications | Comparison between groups A and B for the need of additional IOP lowering medications | 1 year |
| Extent of Resolution of Neovascularization Between Groups | Comparison of groups A and B and the extent of resolution of neovascularization in patients with NVG Stages 1 & 2 | 1 year |
| Evaluation of the Average Retinal Nerve Fiber Layer (RNFL) | Comparison between groups A and B of the average retinal nerve fiber layer (RNFL) as measured by Optical Coherence Tomography (OCT) | 1 year |
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. Aflibercept: Details covered in arm description |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Severity of Adverse Events | Assess the safety profile of repeated intravitreal aflibercept injections in patients with NVG by evaluating the severity of adverse events | Posted | Count of Participants | Participants | 2 year |
|
|
|
| Secondary | Rate and Extent of Resolution of Neovascularization | Compare between Groups A and B the Rate and extent of resolution of neovascularization in patients with NVG Stages 1 & 2. | No data was collected or analyzed for this Outcome Measure | Posted | 1 year |
|
|
| Secondary | Intraocular Pressure (mmHg) at Baseline | Intraocular pressure(mmHg) as measured by Goldmann applanation tonometry between groups A and B | One participant from group Aflibercept with Laser did not complete analysis due to death. Analysis is limited due to small sample size. | Posted | Mean | Full Range | mmHg | Baseline |
|
|
|
| Secondary | Intraocular Pressure (mmHg) at Week 52 | Mean intraocular pressure(mmHg) as measured by Goldmann applanation tonometry between groups A and B | One participant from group Aflibercept with Laser did not complete analysis due to death. Analysis is limited due to small sample size. | Posted | Mean | Full Range | mmHg | Week 52 |
|
|
|
| Secondary | Number of Patients Losing > 5 Letters on Visual Acuity in Each Group A and Group B | Comparison between patients, groups A and B, that lost > 5 letters on visual acuity | One participant from group Aflibercept with Laser did not complete analysis due to death. Analysis is limited due to small sample size. | Posted | Number | participants | Baseline to Week 52 |
|
|
|
| Secondary | Number of Patients in Each, Group A and Group B, Gaining > 5 Letters on Visual Acuity | Comparison of patients in each, group A and group B, that gained > 5 letters on visual acuity | One participant from group Aflibercept with Laser did not complete analysis due to death. Analysis is limited due to small sample size. | Posted | Number | participants | Baseline to Week 52 |
|
|
|
| Secondary | Visual Acuity at Baseline | Comparison of visual acuity between groups A and B | One participant from group Aflibercept with Laser did not complete analysis due to death. Analysis is limited due to small sample size. | Posted | Mean | Full Range | Letters | Baseline |
|
|
|
| Secondary | Visual Acuity at Week 52 | Comparison of visual acuity at Week 52 between groups A and B | One participant from group Aflibercept with Laser did not complete analysis due to death. Analysis is limited due to small sample size. | Posted | Mean | Full Range | Letters | Week 52 |
|
|
|
| Secondary | Comparison of the Visual Field Between Groups | Comparison of the Visual field s measured by HVF 24-2 SITA Standards between groups A and B | No data was collected or analyzed for this Outcome Measure during the clinical trial. | Posted | 1 year |
|
|
| Secondary | Measure of the Optical Coherence Tomography(OCT) Outcomes | Evaluation of the Optical Coherence Tomography(OCT) outcomes (average retinal nerve fiber layer(RNFL) and central macular thickness), Compared between groups A and B. | The database in OCT was corrupted and the data was lost | Posted | Baseline to Week 52 |
|
|
| Secondary | Number of Patients With Need for Surgical Intervention | Comparison between groups A and B and the need for surgical intervention in both arms during the follow-up period | One participant from group Aflibercept with Laser did not complete analysis due to death. Analysis is limited due to small sample size. | Posted | Number | participants | 1 year |
|
|
|
| Secondary | Number of Participants With Need for Additional IOP Lowering Medications | Comparison between groups A and B for the need of additional IOP lowering medications | Posted | Number | participants | 1 year |
|
|
|
| Secondary | Extent of Resolution of Neovascularization Between Groups | Comparison of groups A and B and the extent of resolution of neovascularization in patients with NVG Stages 1 & 2 | NVG Staging not recorded | Posted | 1 year |
|
|
| Secondary | Evaluation of the Average Retinal Nerve Fiber Layer (RNFL) | Comparison between groups A and B of the average retinal nerve fiber layer (RNFL) as measured by Optical Coherence Tomography (OCT) | The OCT database was corrupted and the data was lost | Posted | 1 year |
|
|
| 1 |
| 3 |
| 1 |
| 3 |
| 3 |
| 3 |
| EG001 | 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. | 0 | 4 | 0 | 4 | 4 | 4 |
| Abcess left thigh | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Vitreous hemmorrhage | Eye disorders | Non-systematic Assessment |
|
| Worsening cataract non-study eye | Eye disorders | Non-systematic Assessment |
|
| Worsening Cataract Study eye | Eye disorders | Non-systematic Assessment |
|
| Diabetes Mellitus | Endocrine disorders | Non-systematic Assessment |
|
| Worsening NVG - non-study eye | Eye disorders | Non-systematic Assessment |
|
| shortness of breath | Respiratory, thoracic and mediastinal disorders |
|
| worsening arthritis right knee | Musculoskeletal and connective tissue disorders |
|
| progression of gall bladder cancer | Gastrointestinal disorders |
|
| metastatic cancer affecting liver | Gastrointestinal disorders |
|
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| Severe |
|
| None |
|
| Asthma |
|
| Pneumonia |
|
| Vitreous hemorrhage |
|
| Worsening cataract non-study eye |
|
| Worsening Cataract Study eye |
|
| Diabetes Mellitus |
|
| Worsening NVG - non-study eye |
|
| Recurrent BCC |
|
| progression of gall bladder cancer |
|
| worsening of arthritis Right knee |
|
| matastatic cancer of liver |
|
| shortness of breath |
|