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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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The Endurance Trial is a phase IV open label clinical study to assess the need for ongoing intravitreal aflibercept injections after the 3-year VISTA DME (VGFT-OD-1009; NCT01363440) end-point. Subjects will be treated with intravitreal aflibercept injections pro re nata (PRN) based on the presence of CR-DME (Clinically Relevant-DME). In addition, subjects who meet re-treatment criteria will be eligible for focal laser treatment every 90 days.
The investigational product is aflibercept, which will be supplied by Regeneron Pharmaceuticals, Inc. in sterile vials for intravitreal (IVT) injection. Vials must be used (defined as entered with needle) only once. All drug supplies are to be kept under recommended storage conditions.
The injection volume will be 50μL (0.05 mL) and will be administered to the subjects by IVT injection.
Throughout the trial, subjects will be treated with intravitreal aflibercept injections PRN in the presence of CR-DME; this is defined as DME that the treating investigator believes is limiting visual function.
All subjects will initially be evaluated every 4 weeks (28 days) for CR-DME and treated PRN. If CR-DME is present the subject will receive IVT aflibercept injection. If CR-DME is not present the subject will not receive an IVT aflibercept injection and will be observed.
At any point throughout the study, once a subject has been evaluated and observed (with no IVT aflibercept) for a total of 8 weeks (3 consecutive monthly visits), the interval between visits will be increased to 8 weeks.
After an additional 24 weeks (3 consecutive visits, every 8 weeks) without an IVT aflibercept injection, the interval between visits will be increased to 12 weeks.
If a subject has recurrent CR-DME they will receive an IVT aflibercept injection and the interval between visits will reduce back to 4 weeks. Subjects can again extend the interval between visits to 8 weeks once they have not received an IVT aflibercept injection for a total of 8 weeks (3 consecutive visits) as described above. Extension to 12 weeks is then performed as above.
Starting at week 52, once a subject has extended to a 12 week interval, if CR-DME is not present the subject will not receive an IVT aflibercept injection and will be extended to a 16 week interval. Once at a 16 week interval, if CR-DME is not present the subject will not receive an IVT aflibercept injection and will be extended to a 20 week interval. At any point past a 12 week interval extension, if a subject has recurrent CR-DME they will receive an IVT aflibercept injection and the interval for the next visit will be reduced at investigator discretion to be either 12 or 16 weeks. If the interval is needed to be reduced to below 12 weeks, the subject will return to a 4 or 8 week interval, at investigator discretion and return to the protocol above.
All subjects receiving PRN IVT aflibercept injections will be evaluated for focal laser treatment beginning at week 12 through the end of the study. If the subject meets any of the criteria for focal laser treatment (FLT), fluorescein angiography (FA) will be performed to guide the focal laser treatment. Focal laser treatment and focal laser re-treatment will be administered no more than once every 90 days.
When a subject receives ≥ 2 IVT aflibercept injections in ≤ 24 weeks FLT will be applied. Once the initial session of FLT is applied subjects are eligible for FLT re-treatment after 90 days, when they have received ≥ 2 IVT aflibercept injections within the prior 90 day period.
FLT will be applied to:
FLT will not be applied if any of the following apply and are identified:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRN (pro re nata) | Other | 2 mg intravitreal aflibercept (Eylea) PRN, focal laser administered based on pre-specified criteria, 104 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept | Drug | pro re nata (PRN) |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Intravitreal Aflibercept Injections for Subjects Who Were Enrolled and Completed the 3-year VISTA DME (VGFT-OD-1009) Trial | Measured by evaluating mean number of injections required for subjects who were enrolled and completed the 3-year VISTA DME (VGFT-OD-1009) trial | Week 104 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Early Treatment Diabetic Retinopathy Study Best-corrected Visual Acuity From Baseline to Week 52 and Baseline to Week 104 | Evaluate the mean change over time in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity at week 52 from baseline and at week 104 from baseline. Participants were challenged with reading letters on lines of an eye chart (5 letters per line) in standardized lighting conditions. Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified. |
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Inclusion Criteria:
A subject must meet the following criteria to be eligible for inclusion in the study:
Exclusion Criteria:
A subject who meets any of the following criteria will be excluded from the study:
Prior treatment with anti-VEGF therapy in the study eye within 28 days of baseline
Pregnant or breast-feeding women
Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly).
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| Name | Affiliation | Role |
|---|---|---|
| Charles C Wykoff, MD | Greater Houston Retina Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Consultants of Houston/The Medical Center | Houston | Texas | 77030 | United States | ||
| Retina Consultants of Houston/Katy office |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19545900 | Background | Arevalo JF, Sanchez JG, Wu L, Maia M, Alezzandrini AA, Brito M, Bonafonte S, Lujan S, Diaz-Llopis M, Restrepo N, Rodriguez FJ, Udaondo-Mirete P; Pan-American Collaborative Retina Study Group. Primary intravitreal bevacizumab for diffuse diabetic macular edema: the Pan-American Collaborative Retina Study Group at 24 months. Ophthalmology. 2009 Aug;116(8):1488-97, 1497.e1. doi: 10.1016/j.ophtha.2009.03.016. Epub 2009 Jul 9. | |
| 19171208 |
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| ID | Title | Description |
|---|---|---|
| FG000 | PRN (Pro re Nata) | 2 mg intravitreal aflibercept (Eylea) PRN, focal laser administered based on pre-specified criteria, 104 weeks Aflibercept: pro re nata (PRN) Focal Laser: Focal laser administered based on pre-specified criteria |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | PRN (Pro re Nata) | 2 mg intravitreal aflibercept (Eylea) PRN, focal laser administered based on pre-specified criteria, 104 weeks Aflibercept: pro re nata (PRN) Focal Laser: Focal laser administered based on pre-specified criteria |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mean Number of Intravitreal Aflibercept Injections for Subjects Who Were Enrolled and Completed the 3-year VISTA DME (VGFT-OD-1009) Trial | Measured by evaluating mean number of injections required for subjects who were enrolled and completed the 3-year VISTA DME (VGFT-OD-1009) trial | Posted | Mean | Standard Error | injections | Week 104 |
|
|
104 weeks.
Adverse events were assessed at every study visit during the 2-year study.
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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 | PRN (Pro re Nata) | 2 mg intravitreal aflibercept (Eylea) PRN, focal laser administered based on pre-specified criteria, 104 weeks Aflibercept: pro re nata (PRN) Focal Laser: Focal laser administered based on pre-specified criteria |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment | Resulted in death of a subject. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vitreous hemorrhage | Eye disorders | Systematic Assessment |
Limitations of the ENDURANCE study include the small population and employment of aflibercept re-treatment criteria that allowed physicians to use their varying clinical judgement in determining anti-VEGF re-treatment instead of a strict protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Charles C. Wykoff | Retina Consultants of Houston | 7135243434 | ccwmd@houstonretina.com |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| Focal Laser | Procedure | Focal laser administered based on pre-specified criteria |
|
| Week 52, Week 104 |
| Mean Number of Intravitreal Aflibercept Injections Before and After Receiving First Focal Laser Application. | Measure the role of focal laser treatment (fluorescein angiography-guided, if applicable) in decreasing the treatment burden among subjects who require ongoing aflibercept treatment in the management of diabetic macular edema. | Before First Focal Laser Treatment (FLT) at Week 12 or later; After First FLT at up to 104 weeks |
| Percentage of Subjects With Gain or Loss of 0 to 5 Early Treatment Diabetic Retinopathy Study Best-corrected Visual Acuity Letters From Baseline to Week 52 and Baseline to Week 104 | Evaluate the percentage of subjects with a gain or loss in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity letters in patients treated with aflibercept from baseline to week 52 and baseline to week 104 | Week 52, Week 104 |
| Mean Change in Central Retinal Thickness From Baseline to Week 52 and Baseline to Week 104. | Evaluate the mean change in central retinal thickness from baseline to week 52 and baseline to week 104 in patients treated with aflibercept. | Week 52, Week 104 |
| Number of Subjects With no Clinically-relevant Diabetic Macular Edema (as Defined in the Protocol) on Spectral Domain Optical Coherence Tomography From Baseline to Week 52 and Baseline to Week 104. | Evaluate the number of subjects with no clinically-relevant diabetic macular edema (as defined in the protocol) on spectral domain optical coherence tomography from baseline to week 52 and baseline to week 104 in patients treated with aflibercept. | Week 52, Week 104 |
| Number of Subjects With Stable, Worsened, or Improved Diabetic Retinopathy | Number of subjects with stable, worsened, or improved diabetic retinopathy through 104 weeks. | Week 52, Week 104 |
| Number of Subjects That Receive Focal Laser Treatment. | Number of subjects that receive focal laser treatment from baseline to week 52 and from baseline to week 104. | Week 52, Week 104 |
| Mean Change in Early Treatment Diabetic Retinopathy Study Best-corrected Visual Acuity Before and After Focal Laser Therapy | Evaluation of the effect of laser on Early Treatment Diabetic Retinopathy Study best-corrected visual acuity outcomes. Participants were challenged with reading letters on lines of an eye chart (5 letters per line) in standardized lighting conditions. Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified. | 104 weeks |
| Mean Change in Central Retinal Thickness Before and After First Focal Laser Treatment | Evaluate the mean change in central retinal thickness before and after first focal laser treatment in patients treated with pro re nata aflibercept. | 104 weeks |
| Role of (Ultrawide-field, if Available) Fluorescein Angiography-determined Retinal Ischemia in Predicting Past and Future Anti-VEGF Treatment Burden | Mean number of injections in 52 weeks and 104 weeks based on quantification of ischemic areas | Week 52, Week 104 |
| Role of (Ultrawide-field, if Available) Fluorescein Angiography-determined Retinal Ischemia in Predicting Visual Outcomes | Mean change in visual acuity from baseline to week 52 and baseline to week 104 based on quantification of ischemic areas | Week 52, Week 104 |
| Role of (Ultrawide-field, if Available) Fluorescein Angiography-determined Retinal Ischemia in Predicting Anatomic Outcomes | Mean change in central retinal thickness from baseline to week 52 based on quantification of ischemic areas | Week 52, Week 104 |
| Katy |
| Texas |
| 77494 |
| United States |
| Retina Consultants of Houston | The Woodlands | Texas | 77384 | United States |
| Background |
| Bhagat N, Grigorian RA, Tutela A, Zarbin MA. Diabetic macular edema: pathogenesis and treatment. Surv Ophthalmol. 2009 Jan-Feb;54(1):1-32. doi: 10.1016/j.survophthal.2008.10.001. |
| 9034784 | Background | Ferrara N, Davis-Smyth T. The biology of vascular endothelial growth factor. Endocr Rev. 1997 Feb;18(1):4-25. doi: 10.1210/edrv.18.1.0287. No abstract available. |
| 11102799 | Background | Ferrara N. VEGF: an update on biological and therapeutic aspects. Curr Opin Biotechnol. 2000 Dec;11(6):617-24. doi: 10.1016/s0958-1669(00)00153-1. |
| 18254088 | Background | Grover D, Li TJ, Chong CC. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD005656. doi: 10.1002/14651858.CD005656.pub2. |
| 6521986 | Background | Klein R, Klein BE, Moss SE, Davis MD, DeMets DL. The Wisconsin epidemiologic study of diabetic retinopathy. IV. Diabetic macular edema. Ophthalmology. 1984 Dec;91(12):1464-74. doi: 10.1016/s0161-6420(84)34102-1. |
| 8008348 | Background | Moss SE, Klein R, Klein BE. Ten-year incidence of visual loss in a diabetic population. Ophthalmology. 1994 Jun;101(6):1061-70. doi: 10.1016/s0161-6420(94)31217-6. |
| 9627648 | Background | Moss SE, Klein R, Klein BE. The 14-year incidence of visual loss in a diabetic population. Ophthalmology. 1998 Jun;105(6):998-1003. doi: 10.1016/S0161-6420(98)96025-0. |
| 17046701 | Background | Nguyen QD, Tatlipinar S, Shah SM, Haller JA, Quinlan E, Sung J, Zimmer-Galler I, Do DV, Campochiaro PA. Vascular endothelial growth factor is a critical stimulus for diabetic macular edema. Am J Ophthalmol. 2006 Dec;142(6):961-9. doi: 10.1016/j.ajo.2006.06.068. Epub 2006 Aug 2. |
| 19064858 | Background | Saaddine JB, Honeycutt AA, Narayan KM, Zhang X, Klein R, Boyle JP. Projection of diabetic retinopathy and other major eye diseases among people with diabetes mellitus: United States, 2005-2050. Arch Ophthalmol. 2008 Dec;126(12):1740-7. doi: 10.1001/archopht.126.12.1740. |
| 2866759 | Background | Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group. Arch Ophthalmol. 1985 Dec;103(12):1796-806. |
| 20427088 | Background | Diabetic Retinopathy Clinical Research Network; Elman MJ, Aiello LP, Beck RW, Bressler NM, Bressler SB, Edwards AR, Ferris FL 3rd, Friedman SM, Glassman AR, Miller KM, Scott IU, Stockdale CR, Sun JK. Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology. 2010 Jun;117(6):1064-1077.e35. doi: 10.1016/j.ophtha.2010.02.031. Epub 2010 Apr 28. |
| 20699456 | Background | Zhang X, Saaddine JB, Chou CF, Cotch MF, Cheng YJ, Geiss LS, Gregg EW, Albright AL, Klein BE, Klein R. Prevalence of diabetic retinopathy in the United States, 2005-2008. JAMA. 2010 Aug 11;304(6):649-56. doi: 10.1001/jama.2010.1111. |
| 28814412 | Derived | Wykoff CC, Ou WC, Khurana RN, Brown DM, Lloyd Clark W, Boyer DS; ENDURANCE Study Group. Long-term outcomes with as-needed aflibercept in diabetic macular oedema: 2-year outcomes of the ENDURANCE extension study. Br J Ophthalmol. 2018 May;102(5):631-636. doi: 10.1136/bjophthalmol-2017-310941. Epub 2017 Aug 16. |
| Lost to Follow-up |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Glycated Hemoglobin | Mean | Standard Deviation | Percent |
|
| Duration of Diabetes | Mean | Standard Deviation | years |
|
| Early Treatment Diabetic Retinopathy Study Best-Corrected Visual Acuity | Participants were challenged with reading letters on lines of an eye chart (5 letters per line) in standardized lighting conditions. Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified. | Mean | Standard Deviation | letters |
|
| Central Retinal Thickness | Mean | Standard Deviation | Microns |
|
|
|
| Secondary | Mean Change in Early Treatment Diabetic Retinopathy Study Best-corrected Visual Acuity From Baseline to Week 52 and Baseline to Week 104 | Evaluate the mean change over time in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity at week 52 from baseline and at week 104 from baseline. Participants were challenged with reading letters on lines of an eye chart (5 letters per line) in standardized lighting conditions. Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified. | All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point. | Posted | Mean | Standard Error | letters | Week 52, Week 104 |
|
|
|
| Secondary | Mean Number of Intravitreal Aflibercept Injections Before and After Receiving First Focal Laser Application. | Measure the role of focal laser treatment (fluorescein angiography-guided, if applicable) in decreasing the treatment burden among subjects who require ongoing aflibercept treatment in the management of diabetic macular edema. | Only participants who were eligible for focal laser treatment were analyzed. | Posted | Mean | Standard Deviation | Injections | Before First Focal Laser Treatment (FLT) at Week 12 or later; After First FLT at up to 104 weeks |
|
|
|
| Secondary | Percentage of Subjects With Gain or Loss of 0 to 5 Early Treatment Diabetic Retinopathy Study Best-corrected Visual Acuity Letters From Baseline to Week 52 and Baseline to Week 104 | Evaluate the percentage of subjects with a gain or loss in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity letters in patients treated with aflibercept from baseline to week 52 and baseline to week 104 | All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point. | Posted | Count of Participants | Participants | Week 52, Week 104 |
|
|
|
| Secondary | Mean Change in Central Retinal Thickness From Baseline to Week 52 and Baseline to Week 104. | Evaluate the mean change in central retinal thickness from baseline to week 52 and baseline to week 104 in patients treated with aflibercept. | All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point. | Posted | Mean | Standard Error | Microns | Week 52, Week 104 |
|
|
|
| Secondary | Number of Subjects With no Clinically-relevant Diabetic Macular Edema (as Defined in the Protocol) on Spectral Domain Optical Coherence Tomography From Baseline to Week 52 and Baseline to Week 104. | Evaluate the number of subjects with no clinically-relevant diabetic macular edema (as defined in the protocol) on spectral domain optical coherence tomography from baseline to week 52 and baseline to week 104 in patients treated with aflibercept. | All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point. | Posted | Count of Participants | Participants | Week 52, Week 104 |
|
|
|
| Secondary | Number of Subjects With Stable, Worsened, or Improved Diabetic Retinopathy | Number of subjects with stable, worsened, or improved diabetic retinopathy through 104 weeks. | All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point. | Posted | Count of Participants | Participants | Week 52, Week 104 |
|
|
|
| Secondary | Number of Subjects That Receive Focal Laser Treatment. | Number of subjects that receive focal laser treatment from baseline to week 52 and from baseline to week 104. | All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point. | Posted | Count of Participants | Participants | Week 52, Week 104 |
|
|
|
| Secondary | Mean Change in Early Treatment Diabetic Retinopathy Study Best-corrected Visual Acuity Before and After Focal Laser Therapy | Evaluation of the effect of laser on Early Treatment Diabetic Retinopathy Study best-corrected visual acuity outcomes. Participants were challenged with reading letters on lines of an eye chart (5 letters per line) in standardized lighting conditions. Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified. | All participants receiving laser were included in analysis. | Posted | Mean | Standard Deviation | letters | 104 weeks |
|
|
|
| Secondary | Mean Change in Central Retinal Thickness Before and After First Focal Laser Treatment | Evaluate the mean change in central retinal thickness before and after first focal laser treatment in patients treated with pro re nata aflibercept. | All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point. | Posted | Mean | Standard Error | microns | 104 weeks |
|
|
|
| Secondary | Role of (Ultrawide-field, if Available) Fluorescein Angiography-determined Retinal Ischemia in Predicting Past and Future Anti-VEGF Treatment Burden | Mean number of injections in 52 weeks and 104 weeks based on quantification of ischemic areas | This analysis was never performed because we were logistically unable to collect the data. | Posted | Week 52, Week 104 |
|
|
| Secondary | Role of (Ultrawide-field, if Available) Fluorescein Angiography-determined Retinal Ischemia in Predicting Visual Outcomes | Mean change in visual acuity from baseline to week 52 and baseline to week 104 based on quantification of ischemic areas | This analysis was never performed because we were logistically unable to collect the data. | Posted | Week 52, Week 104 |
|
|
| Secondary | Role of (Ultrawide-field, if Available) Fluorescein Angiography-determined Retinal Ischemia in Predicting Anatomic Outcomes | Mean change in central retinal thickness from baseline to week 52 based on quantification of ischemic areas | This analysis was never performed because we were logistically unable to collect the data. | Posted | Week 52, Week 104 |
|
|
| 1 |
| 60 |
| 19 |
| 60 |
| 26 |
| 60 |
|
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
|
| Stroke | Vascular disorders | Systematic Assessment |
|
| Worsening congestive heart failure | Cardiac disorders | Systematic Assessment |
|
| Acute vision loss secondary to vitreous hemorrhage | Eye disorders | Systematic Assessment |
|
| Acute vision loss due to worsening cataract | Eye disorders | Systematic Assessment |
|
| Worsening staph infection | Infections and infestations | Systematic Assessment |
|
| Acute gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
|
| Cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Worsening arrhythmia | Cardiac disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | Systematic Assessment |
|
| Worsening coronary artery disease | Cardiac disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment | Led to shortness of breath and altered mental status. |
|
| Blocked fistula | Vascular disorders | Systematic Assessment |
|
| Flu | Infections and infestations | Systematic Assessment |
|
| Blocked artery | Vascular disorders | Systematic Assessment |
|
| Accelerated hypertension | Vascular disorders | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | Systematic Assessment | Caused by a MRSA infection. |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
|
| Neovascularization elsewhere | Eye disorders | Systematic Assessment |
|
| Neovascularization of the disc | Eye disorders | Systematic Assessment |
|
| Worsening cataract | Eye disorders | Systematic Assessment |
|
| Corneal abrasion | Eye disorders | Systematic Assessment |
|
| Subconjunctival hemorrhage | Eye disorders | Systematic Assessment |
|
| Superficial punctate keratitis | Eye disorders | Systematic Assessment |
|
| Eye swelling post-cataract extraction | Eye disorders | Systematic Assessment |
|
| Posterior vitreous detachment | Eye disorders | Systematic Assessment |
|
| Floaters | Eye disorders | Systematic Assessment |
|
| Visual disturbance | Eye disorders | Systematic Assessment |
|
| Epiphora | Eye disorders | Systematic Assessment |
|
| Posterior capsule opafication | Eye disorders | Systematic Assessment |
|
| Iritis | Eye disorders | Systematic Assessment |
|
| Eye pain | Eye disorders | Systematic Assessment |
|
| Vitreous debris | Eye disorders | Systematic Assessment |
|
| Optic nerve pallor | Eye disorders | Systematic Assessment |
|
| Decreased vision | Eye disorders | Systematic Assessment |
|
| Ocular sensitivity | Eye disorders | Systematic Assessment |
|
Not provided
Not provided
|
|
|
|
| Improved Diabetic Retinopathy |
|
| Week 104 |
|
|
|
|
|