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Both aflibercept and bevacizumab have been shown to improve vision in eyes with DME. In eyes with DME and at least moderate vision loss, both aflibercept and bevacizumab were also shown to be successful in many eyes. However, aflibercept was shown to be more effective at improving vision, on average, at 1 year and at 2 years. Due to the large cost difference between the two drugs, many clinicians and patients are choosing to initiate treatment with bevacizumab and then switch to aflibercept depending on the eye's response to bevacizumab treatment. However, there is no scientific evidence that this treatment strategy is as effective at improving vision as initiating treatment with aflibercept. Patients and clinicians do not know if this approach ultimately has deleterious effects on visual acuity. If starting with aflibercept is not better than starting with bevacizumab and switching to aflibercept if needed, the potential cost savings to future patients and the health care system would be substantial. However, if starting with aflibercept is better, then patients, clinicians, and health care providers can make informed decisions for how to best treat patients with DME and at least moderate vision loss.
Study Objectives To compare the efficacy of intravitreous aflibercept with intravitreous bevacizumab + deferred aflibercept if needed in eyes with CI DME and moderate vision loss
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aflibercept Group | Active Comparator | 2.0 mg intravitreous aflibercept |
|
| Bevacizumab + Deferred Aflibercept Group | Experimental | 1.25 mg intravitreous bevacizumab + deferred intravitreous 2.0 mg aflibercept if eye meets switch criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravitreous aflibercept | Drug | Intravitreous aflibercept injection is made by Regeneron Pharmaceuticals, Inc. and is approved by the FDA for the treatment of neovascular age-related macular degeneration, macular edema due to central retinal vein occlusion, macular edema due to branch retinal vein occlusion, diabetic macular edema, and diabetic retinopathy in eyes with diabetic macular edema. Study eyes assigned to receive aflibercept will receive a dose of 2.0 mg in 0.05 cc. Aflibercept will be obtained commercially by the clinical site. The physical, chemical, and pharmaceutical properties and formulation of aflibercept are provided in the Package Insert. Intravitreous Injection Technique The injection is preceded by a povidone iodine prep of the conjunctiva. In general, topical antibiotics in the pre-, peri-, or post-injection period should not be used. The injection will be performed using sterile technique |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Visual Acuity | Area under the curve mean change in the electronic early treatment diabetic retinopathy study visual acuity. Visual acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study visual-acuity test on a scale from 100 letters (Snellen equivalent, 20/10) to 0 letters (Snellen equivalent, <20/800), with higher scores indicating better vision. The data presented are the best-corrected visual acuity in the study eye after protocol-defined refraction. The primary outcome was the time-averaged change in the visual-acuity letter score over a period of 104 weeks. The score was derived by calculating the area under the curve (AUC) over the 104-week period for the change in visual acuity from baseline and dividing by the length of follow-up. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Acuity From Baseline | Visual acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study visual-acuity test on a scale from 100 letters (Snellen equivalent, 20/10) to 0 letters (Snellen equivalent, <20/800), with higher scores indicating better vision. | 2 years |
| Increase in E-ETDRS Visual Acuity Letter Score |
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Participant-level Criteria Inclusion
To be eligible, the following inclusion criteria must be met:
Age ≥ 18 years • Individuals <18 years old are not being included because DME is so rare in this age group that the diagnosis of DME may be questionable.
Diagnosis of diabetes mellitus (type 1 or type 2)
Current regular use of insulin for the treatment of diabetes Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes Documented diabetes by American Diabetes Association and/or World Health Organization criteria
At least one eye meets the study eye criteria listed.
Able and willing to provide informed consent.
Exclusion
An individual is not eligible if any of the following exclusion criteria are present:
Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval for the indication being studied at the time of study entry.
• Note: study participants cannot receive another investigational drug while participating in the study.
Known allergy to any component of the study drug or any drug used in the injection prep (including povidone iodine prep).
Blood pressure > 180/110 (systolic above 180 OR diastolic above 110).
• If blood pressure is brought below 180/110 by anti-hypertensive treatment, individual can become eligible.
Systemic anti-VEGF or pro-VEGF treatment within four months prior to randomization or anticipated use during the study.
• These drugs cannot be used during the study.
For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 24 months.
• Women who are potential study participants should be questioned about the potential for pregnancy. Investigator judgment is used to determine when a pregnancy test is needed.
Individual is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the next two years.
Study Eye Criteria The study participant must have at least one eye meeting all of the inclusion criteria and none of the exclusion criteria listed below.
Study participants can have two study eyes only if both eyes are eligible at the time of randomization. For study participants with two eligible eyes, the logistical complexities of the protocol must be considered for each individual prior to randomizing both eyes.
The eligibility criteria for a study eye are as follows:
Inclusion
Best corrected Electronic-Early Treatment Diabetic Retinopathy Study visual acuity letter score < 69 (i.e., 20/50 or worse) and ≥ 24 (i.e., 20/320 or better) within eight days of randomization.
On clinical exam, definite retinal thickening due to diabetic macular edema involving the center of the macula.
Diabetic macular edema present on optical coherence tomography (OCT) within eight days of randomization
Media clarity, pupillary dilation, and individual cooperation sufficient for adequate fundus photographs.
Exclusions
The following exclusions apply to the study eye only (i.e., they may be present for the nonstudy eye):
Macular edema is considered to be due to a cause other than diabetic macular edema.
• An eye should not be considered eligible if: (1) the macular edema is considered to be related to ocular surgery such as cataract extraction or (2) clinical exam and/or OCT suggest that vitreoretinal interface abnormalities (e.g., a taut posterior hyaloid or epiretinal membrane) are the primary cause of the macular edema.
An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition).
An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.).
Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by three lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal).
History of an anti-vascular endothelial growth factor (anti-VEGF) treatment for diabetic macular edema (DME) in the past 12 months or history of any other treatment for DME at any time in the past four months (such as focal/grid macular photocoagulation, intravitreous or peribulbar corticosteroids).
• Enrollment will be limited to a maximum of 25% of the planned sample size with any history of anti-VEGF treatment for DME. Once this number of eyes has been enrolled, any history of anti-VEGF treatment for DME will be an exclusion criterion.
History of pan-retinal photocoagulation within four months prior to randomization or anticipated need for pan-retinal photocoagulation in the six months following randomization.
History of anti-VEGF treatment for a disease other than DME in the past 12 months.
History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior four months or anticipated within the next six months following randomization.
History of YAG capsulotomy performed within two months prior to randomization.
Aphakia.
Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis.
Evidence of uncontrolled glaucoma. • Intraocular pressure must be <30, with no more than one topical glaucoma medication, and no documented glaucomatous field loss for the eye to be eligible
Note, combination therapies are considered more than one medication
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Diagnostic Center | Campbell | California | 95008 | United States | ||
| Macula & Retina Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35833805 | Derived | Jhaveri CD, Glassman AR, Ferris FL 3rd, Liu D, Maguire MG, Allen JB, Baker CW, Browning D, Cunningham MA, Friedman SM, Jampol LM, Marcus DM, Martin DF, Preston CM, Stockdale CR, Sun JK; DRCR Retina Network. Aflibercept Monotherapy or Bevacizumab First for Diabetic Macular Edema. N Engl J Med. 2022 Aug 25;387(8):692-703. doi: 10.1056/NEJMoa2204225. Epub 2022 Jul 14. |
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Participants with both eyes enrolled had one eye in each group (N = 42). Participants could have had 1 (unilateral) or each eye (bilateral) assigned to each group. "Unilateral: "Aflibercept- Monotherapy Group" only (116 participants), "Bevacizumab-First Group" only (112 participants); Bilateral: 42 participants
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| ID | Title | Description |
|---|---|---|
| FG000 | Aflibercept- Monotherapy Group | 2.0 mg intravitreous aflibercept intravitreous aflibercept: Intravitreous aflibercept injection is made by Regeneron Pharmaceuticals, Inc. and is approved by the FDA for the treatment of neovascular age-related macular degeneration, macular edema due to central retinal vein occlusion, macular edema due to branch retinal vein occlusion, diabetic macular edema, and diabetic retinopathy in eyes with diabetic macular edema. Study eyes assigned to receive aflibercept will receive a dose of 2.0 mg in 0.05 cc. Aflibercept will be obtained commercially by the clinical site. The physical, chemical, and pharmaceutical properties and formulation of aflibercept are provided in the Package Insert. Intravitreous Injection Technique The injection is preceded by a povidone iodine prep of the conjunctiva. In general, topical antibiotics in the pre-, peri-, or post-injection period should not be used. The injection will be performed using sterile technique |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 28, 2021 | Jan 11, 2023 |
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|
|
| Bevacizumab + Deferred Aflibercept Group | Drug | Bevacizumab is made by Genentech, Inc. and is approved by the FDA for the treatment of metastatic colorectal cancer as well as the treatment of non-squamous non-small cell lung cancer, glioblastoma, and metastatic renal cell carcinoma. Study eyes assigned to receive bevacizumab will receive a dose of 1.25 mg provided by a single compounding pharmacy identified by the Network and distributed by the Network. The volume of the injections will be 0.05 cc. Intravitreous injection technique: The injection is preceded by a povidone iodine prep of the conjunctiva. In general, topical antibiotics in the pre-, peri-, or post-injection period should not be used. The injection will be performed using a sterile technique. |
|
|
Visual acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual-acuity test on a scale from 100 letters (Snellen equivalent, 20/10) to 0 letters (Snellen equivalent, <20/800), with higher scores indicating better vision. |
| 2 years |
| Decrease in E-ETDRS Visual Acuity Letter Score | Visual acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study visual-acuity test on a scale from 100 letters (Snellen equivalent, 20/10) to 0 letters (Snellen equivalent, <20/800), with higher scores indicating better vision. | 2 years |
| Visual Acuity | Visual acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study visual-acuity test on a scale from 100 letters (Snellen equivalent, 20/10) to 0 letters (Snellen equivalent, <20/800), with higher scores indicating better vision. | 2 years |
| Optical Coherence Tomography Central Subfield Thickness Change From Baseline | Measurements made on the Cirrus device were converted to equivalent scores as would be assessed on the Spectralis device with the use of the following formula: Spectralis score = 40.78 + 0.95 × Cirrus score. | 2 years |
| Optical Coherence Tomography Central Subfield Thickness Below the Sex-specific Threshold for Central-involved Diabetic Macular Edema | Optical coherence tomography (OCT) central subfield thickness equivalents for measurements obtained on Spectral domain OCT machines were 320 μm for men and 305 μm for women on the Spectralis device (Heidelberg) and were 305 μm and 290 μm, respectively on the Cirrus OCT measurement device (Zeiss). | 2 years |
| Number of Visits | 2 years |
| Number of Injections | All study injections were counted, including aflibercept injections received among eyes in the bevacizumab first group. | 2 years |
| Number of Eyes in the Bevacizumab-first Group Meeting the Switching Criteria | Baseline to 12 weeks |
| Number of Eyes in the Bevacizumab-first Group Meeting the Switching Criteria | Baseline to 24 weeks |
| Number of Eyes in the Bevacizumab-first Group Meeting the Switching Criteria | Baseline to 52 weeks |
| Number of Eyes in the Bevacizumab-first Group Meeting the Switching Criteria | Baseline to 104 weeks |
| Glendale |
| California |
| 91203 |
| United States |
| Loma Linda University Health Care, Department of Ophthalmology | Loma Linda | California | 92354 | United States |
| East Bay Retina Consultants, Inc | Oakland | California | 94609-3028 | United States |
| National Ophthalmic Research Institute | Fort Myers | Florida | 33912 | United States |
| Florida Retina Institute-Jacksonville | Jacksonville | Florida | 32216 | United States |
| Florida Retina Consultants | Lakeland | Florida | 33805 | United States |
| Retina Macula Specialists of Miami | Miami | Florida | 33126 | United States |
| Central Florida Retina | Orlando | Florida | 32806 | United States |
| Florida Retina Institute | Orlando | Florida | 32806 | United States |
| Southeast Eye Institute, P.A. dba Eye Associates of Pinellas | Pinellas Park | Florida | 33782 | United States |
| Fort Lauderdale Eye Institute | Plantation | Florida | 33324 | United States |
| Retina Associates of Sarasota | Sarasota | Florida | 34233 | United States |
| Sarasota Retina Institute | Sarasota | Florida | 34239 | United States |
| Retina Associates of Florida, LLC | Tampa | Florida | 33609 | United States |
| Retina Specialists of Tampa | Wesley Chapel | Florida | 33544 | United States |
| Southeast Retina Center, P.C. | Augusta | Georgia | 30909 | United States |
| Thomas Eye Group | Sandy Springs | Georgia | 30328 | United States |
| Illinois Retina Associates, S.C. | Oak Park | Illinois | 60304 | United States |
| Springfield Clinic, LLP | Springfield | Illinois | 62703 | United States |
| Raj K. Maturi, M.D., P.C. | Indianapolis | Indiana | 46290 | United States |
| John-Kenyon American Eye Institute | New Albany | Indiana | 47150 | United States |
| Mid-America Retina Consultants, P.A. | Overland Park | Kansas | 66211 | United States |
| Retina Associates, P.A. | Shawnee Mission | Kansas | 66204 | United States |
| Paducah Retinal Center | Paducah | Kentucky | 42001 | United States |
| Eye Associates of Northeast Louisiana dba Haik Humble Eye Center | West Monroe | Louisiana | 71291 | United States |
| Mid Atlantic Retina Specialists | Hagerstown | Maryland | 21740 | United States |
| Valley Eye Physicians and Surgeons | Ayer | Massachusetts | 01432 | United States |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
| Retina Specialists of Michigan | Grand Rapids | Michigan | 49546 | United States |
| Vitreo-Retinal Associates | Grand Rapids | Michigan | 49546 | United States |
| The Retina Institute | St Louis | Missouri | 63128 | United States |
| Eye Associates of New Mexico | Albuquerque | New Mexico | 87109 | United States |
| MaculaCare | New York | New York | 10021 | United States |
| Retina Associates of Western New York | Rochester | New York | 14620 | United States |
| Western Carolina Clinical Research, LLC | Asheville | North Carolina | 28803 | United States |
| Charlotte Eye, Ear, Nose and Throat Assoc., PA | Charlotte | North Carolina | 28210 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Dean A. McGee Eye Institute | Oklahoma City | Oklahoma | 73104 | United States |
| Retina Northwest, PC | Portland | Oregon | 97221 | United States |
| Cascade Medical Research Institute, LLC | Springfield | Oregon | 97477 | United States |
| Retina Vitreous Consultants | Monroeville | Pennsylvania | 15146 | United States |
| Retinavitreous Associates, dba; Mid Atlantic Retina | Philadelphia | Pennsylvania | 19107-5109 | United States |
| Southeastern Retina Associates, P.C. | Knoxville | Tennessee | 37909 | United States |
| Austin Retina Associates | Austin | Texas | 78705 | United States |
| Retina Research Center | Austin | Texas | 78705 | United States |
| Retina Center of Texas | Grapevine | Texas | 76051 | United States |
| Baylor Eye Physicians and Surgeons | Houston | Texas | 77030 | United States |
| Retina Consultants of Houston, PA | Houston | Texas | 77030 | United States |
| Texas Retina Associates | Lubbock | Texas | 79424 | United States |
| Valley Retina Institute | McAllen | Texas | 78503 | United States |
| Retinal Consultants of San Antonio | San Antonio | Texas | 78240 | United States |
| Spokane Eye Clinic | Spokane | Washington | 99204 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| FG001 | Bevacizumab-First Group | 1.25 mg intravitreous bevacizumab + deferred intravitreous 2.0 mg aflibercept if eye meets switch criteria Bevacizumab + Deferred Aflibercept Group: Bevacizumab is made by Genentech, Inc. and is approved by the FDA for the treatment of metastatic colorectal cancer as well as the treatment of non-squamous non-small cell lung cancer, glioblastoma, and metastatic renal cell carcinoma. Study eyes assigned to receive bevacizumab will receive a dose of 1.25 mg provided by a single compounding pharmacy identified by the Network and distributed by the Network. The volume of the injections will be 0.05 cc. Intravitreous injection technique: The injection is preceded by a povidone iodine prep of the conjunctiva. In general, topical antibiotics in the pre-, peri-, or post-injection period should not be used. The injection will be performed using a sterile technique. |
| COMPLETED |
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| NOT COMPLETED |
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Units in Eyes
| ID | Title | Description |
|---|---|---|
| BG000 | Aflibercept- Monotherapy Group | 2.0 mg intravitreous aflibercept intravitreous aflibercept: Intravitreous aflibercept injection is made by Regeneron Pharmaceuticals, Inc. and is approved by the FDA for the treatment of neovascular age-related macular degeneration, macular edema due to central retinal vein occlusion, macular edema due to branch retinal vein occlusion, diabetic macular edema, and diabetic retinopathy in eyes with diabetic macular edema. Study eyes assigned to receive aflibercept will receive a dose of 2.0 mg in 0.05 cc. Aflibercept will be obtained commercially by the clinical site. The physical, chemical, and pharmaceutical properties and formulation of aflibercept are provided in the Package Insert. Intravitreous Injection Technique The injection is preceded by a povidone iodine prep of the conjunctiva. In general, topical antibiotics in the pre-, peri-, or post-injection period should not be used. The injection will be performed using sterile technique |
| BG001 | Bevacizumab-First Group | 1.25 mg intravitreous bevacizumab + deferred intravitreous 2.0 mg aflibercept if eye meets switch criteria. 1.25 mg intravitreous bevacizumab was administered at randomization and thereafter according to the prespecified retreatment protocol. Beginning at 12 weeks, and only if protocol-specified criteria were met, eyes in this group stopped bevacizumab therapy and started aflibercept therapy. Bevacizumab + Deferred Aflibercept Group: Bevacizumab is made by Genentech, Inc. and is approved by the FDA for the treatment of metastatic colorectal cancer as well as the treatment of non-squamous non-small cell lung cancer, glioblastoma, and metastatic renal cell carcinoma. Study eyes assigned to receive bevacizumab will receive a dose of 1.25 mg provided by a single compounding pharmacy identified by the Network and distributed by the Network. The volume of the injections will be 0.05 cc. Intravitreous injection technique: The injection is preceded by a povidone iodine prep of the conjunctiva. In general, topical antibiotics in the pre-, peri-, or post-injection period should not be used. The injection will be performed using a sterile technique. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Eyes |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 84 eyes were enrolled with from 42 participants with two study eyes (i.e., one eye in each treatment group). | Median | Inter-Quartile Range | years | Eyes |
|
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| Sex/Gender, Customized | Count of Units | Eyes | Eyes |
| |||||||||||||||||||||
| Race/Ethnicity, Customized | 84 eyes were enrolled with from 42 participants with two study eyes (i.e., one eye in each treatment group). | Count of Units | Eyes | Eyes |
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| Type of diabetes | 84 eyes were enrolled with from 42 participants with two study eyes (i.e., one eye in each treatment group). | Count of Units | Eyes | Eyes |
| ||||||||||||||||||||
| Duration of diabetes | Median | Inter-Quartile Range | years | Eyes |
| ||||||||||||||||||||
| Glycated hemoglobin | Data on the glycated hemoglobin level were unavailable for 10 eyes in each trial group. | Median | Inter-Quartile Range | Hemoglobin A1c percentage | Eyes |
| |||||||||||||||||||
| Visual acuity letter score | Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent <20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity. | 84 eyes were enrolled with from 42 participants with two study eyes (i.e., one eye in each treatment group). | Median | Inter-Quartile Range | units on a scale | Eyes |
| ||||||||||||||||||
| Central subfield thickness | Measurements made on the Cirrus optical coherence tomography device were converted to equivalent scores as would be assessed on the Spectralis optical coherence tomography device with the use of the following formula: Spectralis score = 40.78 + 0.95 × Cirrus score. | Data were unavailable for two eyes in the aflibercept-monotherapy group; a optical coherence tomography reading center confirmed the presence of diabetic macular edema in these eyes. 84 eyes were enrolled with from 42 participants with two study eyes (i.e., one eye in each treatment group). | Median | Inter-Quartile Range | Microns | Eyes |
| ||||||||||||||||||
| Diabetic retinopathy severity scale | Severity levels include 12 discrete steps ranging from 10 to 85, with higher levels indicating greater severity. Level was based on assessment by the reading center. | Data were not available for one eye in the bevacizumab-first group. Eyes could not be graded for seven eyes in the aflibercept-monotherapy group and for six eyes in the bevacizumab-first group. Percentages are based on the numbers of eyes with gradable severity of diabetic retinopathy at baseline. 84 eyes were enrolled with from 42 participants with two study eyes (i.e., one eye in each treatment group). | Count of Units | Eyes | Eyes |
| |||||||||||||||||||
| Previous anti-VEGF treatment for diabetic macular edema | anti-VEGF = vascular endothelial growth factor. | Number | Eyes | Eyes |
|
| 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 Change in Visual Acuity | Area under the curve mean change in the electronic early treatment diabetic retinopathy study visual acuity. Visual acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study visual-acuity test on a scale from 100 letters (Snellen equivalent, 20/10) to 0 letters (Snellen equivalent, <20/800), with higher scores indicating better vision. The data presented are the best-corrected visual acuity in the study eye after protocol-defined refraction. The primary outcome was the time-averaged change in the visual-acuity letter score over a period of 104 weeks. The score was derived by calculating the area under the curve (AUC) over the 104-week period for the change in visual acuity from baseline and dividing by the length of follow-up. | Posted | Mean | Standard Deviation | Letter Score | 2 years | Eyes | Eyes |
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| Secondary | Change in Visual Acuity From Baseline | Visual acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study visual-acuity test on a scale from 100 letters (Snellen equivalent, 20/10) to 0 letters (Snellen equivalent, <20/800), with higher scores indicating better vision. | Posted | Mean | Standard Deviation | Letter Score | 2 years | Eyes | Eyes |
| |||||||||||||||||||||||||||||||
| Secondary | Increase in E-ETDRS Visual Acuity Letter Score | Visual acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual-acuity test on a scale from 100 letters (Snellen equivalent, 20/10) to 0 letters (Snellen equivalent, <20/800), with higher scores indicating better vision. | Posted | Count of Units | Eyes | 2 years | Eyes | Eyes |
| ||||||||||||||||||||||||||||||||
| Secondary | Decrease in E-ETDRS Visual Acuity Letter Score | Visual acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study visual-acuity test on a scale from 100 letters (Snellen equivalent, 20/10) to 0 letters (Snellen equivalent, <20/800), with higher scores indicating better vision. | Posted | Count of Units | Eyes | 2 years | Eyes | Eyes |
| ||||||||||||||||||||||||||||||||
| Secondary | Visual Acuity | Visual acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study visual-acuity test on a scale from 100 letters (Snellen equivalent, 20/10) to 0 letters (Snellen equivalent, <20/800), with higher scores indicating better vision. | Posted | Count of Units | Eyes | 2 years | Eyes | Eyes |
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| Secondary | Optical Coherence Tomography Central Subfield Thickness Change From Baseline | Measurements made on the Cirrus device were converted to equivalent scores as would be assessed on the Spectralis device with the use of the following formula: Spectralis score = 40.78 + 0.95 × Cirrus score. | The analysis included only eyes for which baseline data on the central subfield thickness were available. | Posted | Mean | Standard Deviation | microns | 2 years | Eyes | Eyes |
| ||||||||||||||||||||||||||||||
| Secondary | Optical Coherence Tomography Central Subfield Thickness Below the Sex-specific Threshold for Central-involved Diabetic Macular Edema | Optical coherence tomography (OCT) central subfield thickness equivalents for measurements obtained on Spectral domain OCT machines were 320 μm for men and 305 μm for women on the Spectralis device (Heidelberg) and were 305 μm and 290 μm, respectively on the Cirrus OCT measurement device (Zeiss). | The analysis included only eyes for which baseline data on the central subfield thickness were available. | Posted | Count of Units | Eyes | 2 years | Eyes | Eyes |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Visits | This analysis was limited to patients with one study eye who completed 2 years of follow-up. | Posted | Mean | Standard Deviation | visits | 2 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Injections | All study injections were counted, including aflibercept injections received among eyes in the bevacizumab first group. | Limited to eyes that completed the 2-year visit or any later common visit. | Posted | Mean | Standard Deviation | injections | 2 years | Eyes | Eyes |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Eyes in the Bevacizumab-first Group Meeting the Switching Criteria | Eyes that did not meet the switch criteria were censored at the last completed visit | Posted | Number | Eyes | Baseline to 12 weeks | Eyes | Eyes |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Eyes in the Bevacizumab-first Group Meeting the Switching Criteria | Eyes that did not meet the switch criteria were censored at the last completed visit | Posted | Number | Eyes | Baseline to 24 weeks | Eyes | Eyes |
|
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| Secondary | Number of Eyes in the Bevacizumab-first Group Meeting the Switching Criteria | Eyes that did not meet the switch criteria were censored at the last completed visit | Posted | Number | Eyes | Baseline to 52 weeks | Eyes | Eyes |
|
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| Secondary | Number of Eyes in the Bevacizumab-first Group Meeting the Switching Criteria | Eyes that did not meet the switch criteria were censored at the last completed visit | Posted | Number | Eyes | Baseline to 104 weeks | Eyes | Eyes |
|
|
2 Years
To get the total number of participant/eyes in each treatment group add the unilateral and bilateral participants together:
Unilateral Aflibercept monotherapy = 116 Total Aflibercept monotherapy = unilateral Aflibercept monotherapy + bilateral = 116 + 42 = 158 Unilateral Bevacizumab first = 112 total Bevacizumab first = unilateral Bevacizumab first + bilateral = 112 + 42 = 154.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Unilateral Aflibercept- Monotherapy Group | 2.0 mg intravitreous aflibercept intravitreous aflibercept: Intravitreous aflibercept injection is made by Regeneron Pharmaceuticals, Inc. and is approved by the FDA for the treatment of neovascular age-related macular degeneration, macular edema due to central retinal vein occlusion, macular edema due to branch retinal vein occlusion, diabetic macular edema, and diabetic retinopathy in eyes with diabetic macular edema. Study eyes assigned to receive aflibercept will receive a dose of 2.0 mg in 0.05 cc. Aflibercept will be obtained commercially by the clinical site. The physical, chemical, and pharmaceutical properties and formulation of aflibercept are provided in the Package Insert. Intravitreous Injection Technique The injection is preceded by a povidone iodine prep of the conjunctiva. In general, topical antibiotics in the pre-, peri-, or post-injection period should not be used. The injection will be performed using sterile technique. | 10 | 116 | 61 | 116 | 100 | 116 |
| EG001 | Unilateral Bevacizumab-First Group | 1.25 mg intravitreous bevacizumab + deferred intravitreous 2.0 mg aflibercept if eye meets switch criteria Bevacizumab + Deferred Aflibercept Group: Bevacizumab is made by Genentech, Inc. and is approved by the FDA for the treatment of metastatic colorectal cancer as well as the treatment of non-squamous non-small cell lung cancer, glioblastoma, and metastatic renal cell carcinoma. Study eyes assigned to receive bevacizumab will receive a dose of 1.25 mg provided by a single compounding pharmacy identified by the Network and distributed by the Network. The volume of the injections will be 0.05 cc. Intravitreous injection technique: The injection is preceded by a povidone iodine prep of the conjunctiva. In general, topical antibiotics in the pre-, peri-, or post-injection period should not be used. The injection will be performed using a sterile technique. For participants who switched from Bevacizumab to Aflibercept, all randomized eyes are included in the safety analysis and analyzed according to treatment assignment at randomization, regardless of the treatment actually received. | 4 | 112 | 42 | 112 | 94 | 112 |
| EG002 | Bilateral Participants | Participants with one eye enrolled in each arm of the study. For participants who switched from Bevacizumab to Aflibercept, all randomized eyes are included in the safety analysis and analyzed according to treatment assignment at randomization, regardless of the treatment actually received. Ocular adverse events specific to each treatment are reported as footnotes. | 3 | 42 | 18 | 42 | 40 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Anemia of chronic disease | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Enlargement of lymph nodes | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| AFib | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Congenital heart disease NOS | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Congestive heart failure | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Heart block first degree | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Heart failure | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Diabetes | Endocrine disorders | MedDRA | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Endocrine disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperglycemia | Endocrine disorders | MedDRA | Non-systematic Assessment |
| |
| Hypoglycemia | Endocrine disorders | MedDRA | Non-systematic Assessment |
| |
| Worsening of diabetes | Endocrine disorders | MedDRA | Non-systematic Assessment |
| |
| Double vision | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Bevacizumab-First Group. |
|
| Endophthalmitis | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Penetrating eye injury | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Rhegmatogenous retinal detachment | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Vision decreased | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Vitreous hemorrhage | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Diabetic gastroparesis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastro intestinal bleeding | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastrointestinal motility disorder | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Indigestion | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Stomach pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Stomach virus | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA | Non-systematic Assessment |
| |
| General Swelling | General disorders | MedDRA | Non-systematic Assessment |
| |
| Necrosis | General disorders | MedDRA | Non-systematic Assessment |
| |
| Peripheral edema | General disorders | MedDRA | Non-systematic Assessment |
| |
| Hepatic encephalopathy | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Liver cirrhosis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Bacteremia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| E. coli infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Foot infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Salmonella | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Subdural hematoma (traumatic) | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Blood sugar decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Decreased hemoglobin | Investigations | MedDRA | Non-systematic Assessment |
| |
| Decreased white cell count | Investigations | MedDRA | Non-systematic Assessment |
| |
| Elevated liver enzymes | Investigations | MedDRA | Non-systematic Assessment |
| |
| Potassium high | Investigations | MedDRA | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Water retention | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Ankle fracture | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Broken bones | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Femoral neck fracture | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Foot fracture | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Fractured ethmoid | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Fractured maxilla | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Gout | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Hip fracture | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Necrotizing fasciitis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Osteomyelitis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Wrist fracture | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Bell's palsy | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Brain tumor | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Consciousness loss | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Fainting | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Hypoglycemic encephalopathy | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Numbness facial | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Seizures | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Shakiness | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Mental state abnormal | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Stress | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Acute renal failure | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Chronic renal failure worsened | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Kidney failure | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Kidney function abnormal | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Kidney stones | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Urinary tract infection | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Acute on chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Exacerbation of asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Hypoxemia | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Cellulitis of foot | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Cellulitis of leg | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Diabetic foot ulcer | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Diabetic ulcer | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Foot ulcer | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Gangrene | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Aortic valve replacement | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Blood transfusion | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Debridement | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Gallbladder removal | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Gastric bypass surgery | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Knee surgery NOS | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Leg amputation | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Open heart surgery | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Toe amputation | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Hypertension worsened | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Internal carotid aneurysm | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Ischemic stroke | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Stroke | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Stroke (cerebrovascular accident) | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Stroke - Ischemic | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Transient ischemic attacks | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Venous stenosis | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Anemia of chronic disease | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Lymphangitis | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Bundle branch block | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Cardiac arrhythmia | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Congestive heart failure | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Heart block first degree | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Heart failure | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Ischemic cardiomyopathy | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Left ventricular systolic dysfunction | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Mitral regurgitation | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Premature ventricular contractions | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Tricuspid regurgitation | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Ear infection | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
| |
| Otitis media acute | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
| |
| Diabetes | Endocrine disorders | MedDRA | Non-systematic Assessment |
| |
| Diabetes mellitus poor control | Endocrine disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperglycemia | Endocrine disorders | MedDRA | Non-systematic Assessment |
| |
| Hypoglycemia | Endocrine disorders | MedDRA | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA | Non-systematic Assessment |
| |
| Loss of control of blood sugar | Endocrine disorders | MedDRA | Non-systematic Assessment |
| |
| Worsening of diabetes | Endocrine disorders | MedDRA | Non-systematic Assessment |
| |
| Abnormal vision | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Aflibercept-Monotherapy Group. |
|
| Age-related macular degeneration | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Aflibercept-Monotherapy Group, 1 (1) in Bevacizumab-First Group. |
|
| Anatomical narrow angle borderline glaucoma | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Anterior chamber cell | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Arcus senilis | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Aflibercept-Monotherapy Group, 1 (1) in Bevacizumab-First Group. |
|
| Blepharitis (eyelid irritation) | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Blurred vision | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Blurry vision | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Bevacizumab-First Group. |
|
| Borderline glaucoma (glaucoma suspect) | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Branch retinal artery occlusion | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Burning eyes | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 6 (8) in Aflibercept-Monotherapy Group, 4 (5) in Bevacizumab-First Group. |
|
| Cataract cortical | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 2 (2) in Aflibercept-Monotherapy Group, 2 (2) in Bevacizumab-First Group. |
|
| Central retinal vein occlusion | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Chalazion | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Chemosis (conjunctival edema) | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Aflibercept-Monotherapy Group. |
|
| Choroidal nevus | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Bevacizumab-First Group. |
|
| Cloudy vision | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Color vision change | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 2 (2) in Aflibercept-Monotherapy Group. |
|
| Contusion of orbital tissues | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Corneal abrasion | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Aflibercept-Monotherapy Group, 2 (3) in Bevacizumab-First Group. |
|
| Corneal defect | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Corneal endothelial disorder | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Aflibercept-Monotherapy Group, 1 (1) in Bevacizumab-First Group. |
|
| Corneal epithelium defect | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Corneal haze | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Corneal opacity | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Aflibercept-Monotherapy Group, 1 (1) in Bevacizumab-First Group. |
|
| Corneal scar | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Corneal ulcer | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Cortical spoking | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Cotton wool spots | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Aflibercept-Monotherapy Group. |
|
| Cupping of optic nerve | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Cystoid macular edema | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Diabetic macular edema | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Aflibercept-Monotherapy Group. |
|
| Disc neovascularization | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Aflibercept-Monotherapy Group. |
|
| Dry eye | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 2 (2) in Aflibercept-Monotherapy Group, 2 (2) in Bevacizumab-First Group. |
|
| Dry eye syndrome | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Epiretinal membrane | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 2 (2) in Aflibercept-Monotherapy Group. |
|
| Eye ache | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 2 (3) in Aflibercept-Monotherapy Group, 1 (1) in Bevacizumab-First Group. |
|
| Eye pain | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 2 (2) in Aflibercept-Monotherapy Group, 1 (1) in Bevacizumab-First Group. |
|
| Eye swelling | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Eye tearing | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Aflibercept-Monotherapy Group, 1 (1) in Bevacizumab-First Group. |
|
| Eyelid pain | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Flame-shaped hemorrhage | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Floaters | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 3 (3) in Aflibercept-Monotherapy Group, 4 (4) in Bevacizumab-First Group. |
|
| Foreign body sensation in eyes | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Aflibercept-Monotherapy Group. |
|
| Glaucoma | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Aflibercept-Monotherapy Group, 1 (1) in Bevacizumab-First Group. |
|
| Hordeolum | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Hypertensive retinopathy | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Incipient senile cataract | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Intraretinal microvascular abnormalities | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Iris neovascularization | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Iritis (anterior uveitis, iridocyclitis) | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Ischemic optic neuropathy | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Lattice degeneration of retina | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Lens disorder NOS | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Macular edema | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Aflibercept-Monotherapy Group, 1 (1) in Bevacizumab-First Group. |
|
| Macular hole | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Macular ischemia | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Neovascular glaucoma | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Nuclear sclerosis | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 2 (2) in Aflibercept-Monotherapy Group, 1 (1) in Bevacizumab-First Group. |
|
| Ocular discomfort | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Aflibercept-Monotherapy Group. |
|
| Ocular hypertension | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Optic disc disorder | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Bevacizumab-First Group. |
|
| Posterior capsule opacification | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 2 (2) in Aflibercept-Monotherapy Group, 1 (1) in Bevacizumab-First Group. |
|
| Posterior subcapsular cataract | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 4 (5) in Aflibercept-Monotherapy Group, 4 (4) in Bevacizumab-First Group. |
|
| Posterior vitreous detachment | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 3 (3) in Aflibercept-Monotherapy Group. |
|
| Preretinal hemorrhage | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Aflibercept-Monotherapy Group. |
|
| Proliferative diabetic retinopathy | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Bevacizumab-First Group. |
|
| Punctate epithelial erosion | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Aflibercept-Monotherapy Group, 1 (1) in Bevacizumab-First Group. |
|
| Red eye | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Retinal angiosclerosis | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Retinal artery embolism | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (2) in Aflibercept-Monotherapy Group, 1 (1) in Bevacizumab-First Group. |
|
| Retinal edema | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Retinal exudates | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Retinal hemorrhage | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Retinal hole | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Aflibercept-Monotherapy Group, 1 (1) in Bevacizumab-First Group. |
|
| Retinal microaneurysms NOS | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Retinal pigment epitheliopathy | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Retinoschisis | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Aflibercept-Monotherapy Group, 1 (1) in Bevacizumab-First Group. |
|
| Scleritis | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Sensitivity to light (photophobia) | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Serous retinal detachment | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Silicone oil droplets | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Soreness in eyes | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Subconjunctival hemorrhage | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 6 (14) in Aflibercept-Monotherapy Group, 4 (13) in Bevacizumab-First Group. |
|
| Subconjunctival/conjunctival hemorrhage | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Subretinal hemorrhage | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Bevacizumab-First Group. |
|
| Superficial punctate keratitis | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 4 (4) in Aflibercept-Monotherapy Group, 3 (3) in Bevacizumab-First Group. |
|
| Swollen eyelid | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Swollen eyes | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Aflibercept-Monotherapy Group. |
|
| Traction retinal detachment | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Vision abnormal | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Vision decreased | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Aflibercept-Monotherapy Group, 2 (2) in Bevacizumab-First Group. |
|
| Visual acuity decreased | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Visual disturbances | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Aflibercept-Monotherapy Group, 1 (1) in Bevacizumab-First Group. |
|
| Visual field defect | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Visual flashes | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Vitreal cells | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Vitreomacular traction syndrome | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Vitreous floater | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Aflibercept-Monotherapy Group. |
|
| Vitreous hemorrhage | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 4 (6) in Aflibercept-Monotherapy Group, 5 (5) in Bevacizumab-First Group. |
|
| Vitreous opacities | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Aflibercept-Monotherapy Group, 1 (1) in Bevacizumab-First Group. |
|
| Vitreous opacity | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Aflibercept-Monotherapy Group. |
|
| Watering eyes | Eye disorders | MedDRA | Non-systematic Assessment | Affected (# Events): 1 (1) in Aflibercept-Monotherapy Group, 1 (1) in Bevacizumab-First Group. |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Acid reflux (oesophageal) | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Bloody stool | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Colonic polyp | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Diabetic gastroparesis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Disease Crohns | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastro intestinal bleeding | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastroesophageal reflux | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastroparesis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Heartburn | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Hiatal hernia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Indigestion | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Lymphocytic colitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Reflux esophagitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Small intestinal bacterial overgrowth | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Stomach virus | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Tooth infection | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Upset stomach | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Ache NOS | General disorders | MedDRA | Non-systematic Assessment |
| |
| Anasarca | General disorders | MedDRA | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Non-systematic Assessment |
| |
| Chest pressure | General disorders | MedDRA | Non-systematic Assessment |
| |
| Cyst | General disorders | MedDRA | Non-systematic Assessment |
| |
| Dialysis access malfunction | General disorders | MedDRA | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
| |
| Fever | General disorders | MedDRA | Non-systematic Assessment |
| |
| General Swelling | General disorders | MedDRA | Non-systematic Assessment |
| |
| Hernia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Hot flashes | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA | Non-systematic Assessment |
| |
| Leg edema | General disorders | MedDRA | Non-systematic Assessment |
| |
| Localized superficial swelling, mass, or lump | General disorders | MedDRA | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA | Non-systematic Assessment |
| |
| Pain NOS | General disorders | MedDRA | Non-systematic Assessment |
| |
| Pedal edema | General disorders | MedDRA | Non-systematic Assessment |
| |
| Swelling of feet | General disorders | MedDRA | Non-systematic Assessment |
| |
| Acute cholecystitis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Hepatic encephalopathy | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Non-alcoholic fatty liver | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Abscess NOS | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Bacteremia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Enterococcus faecalis infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Foot infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Fungal infection of nail | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Infected toe | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| MRSA | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Septicemia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Staphylococcal infection NOS | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Thrush | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Tinea cruris | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Yeast infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Back injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Burn | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Foot injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Knee injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Leg injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Ligament tear | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Pulmonary contusion | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Spider bite | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Angiogram | Investigations | MedDRA | Non-systematic Assessment |
| |
| Creatinine abnormal NOS | Investigations | MedDRA | Non-systematic Assessment |
| |
| Elevated liver enzymes | Investigations | MedDRA | Non-systematic Assessment |
| |
| Esophagogastroduodenoscopy | Investigations | MedDRA | Non-systematic Assessment |
| |
| Free prostate-specific antigen increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| HbA1C increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| LDL cholesterol increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Laboratory test abnormal | Investigations | MedDRA | Non-systematic Assessment |
| |
| Oxygen saturation low | Investigations | MedDRA | Non-systematic Assessment |
| |
| Potassium high | Investigations | MedDRA | Non-systematic Assessment |
| |
| Red blood cell count decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Testosterone low | Investigations | MedDRA | Non-systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Abnormal weight gain | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Fluid overload - fluid volume increased | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Folic acid deficiency | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypercholesteremia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypercholesterolemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperlipidemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Water retention | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Ankle fracture | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Ankle injury | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Arthritis NOS | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Back discomfort | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Broken bones | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Bunion | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Degenerative disc disease | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Degenerative joint disease | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Foot fracture | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Foot pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Fractured ribs | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Gout | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Hand pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Intervertebral disc bulging | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Knee pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Leg cramps | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Leg pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Muscle pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Necrotizing fasciitis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Osteomyelitis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Pain in arm | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Pain in hip | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Painful feet | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Shoulder blade pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Shoulder fracture | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Sprained ankle | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Sprains and strains of ribs | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Swelling of knees | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| temporomandibular joint disorder | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Bell's palsy | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Consciousness loss | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Fainting | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Head pain | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Head pressure | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Lumbar spinal stenosis | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Memory deficit | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Migraine headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Neuropathy | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Numbness generalized | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Nystagmus | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Ophthalmic migraine | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Pseudotumor cerebri | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| VIth nerve palsy | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Vertigo | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Walking difficulty - Neurologic | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Weakness left or right side | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Difficulty sleeping | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Hallucinations | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Stress | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Bladder infection | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Chronic renal failure worsened | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Hematuria (blood in urine) | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Kidney failure | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Kidney function abnormal | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Kidney infection | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Kidney stones | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Overactive bladder | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Renal insufficiency | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Urinary tract infection | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Enlarged prostate | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Epididymitis | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Vaginal dryness | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Acute bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Acute sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Chest congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Cold | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Hypoxemia | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Lung disease obstructive | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Nose bleed | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Respiratory infection | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Sinus infection | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Sleep apnea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Streptococcal sore throat | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Allergic skin reaction | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Blister of foot and toe(s), without mention of infection | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Boil | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Bruise | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Cellulitis of foot | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Cellulitis of leg | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Congenital nevus | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dermatochalasis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Diabetic foot ulcer | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Diabetic ulcer | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Erythematous conditions | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Foot ulcer | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Ingrown toe nail | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Leg ulcer | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Shingles | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Skin abrasion | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Skin bacterial infection | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Skin callus | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Skin infection | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Back surgery | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
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| Cataract extraction | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
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| Debridement | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
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| Knee surgery NOS | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
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| Pacemaker insertion (cardiac) | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
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| Root canal procedure | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
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| Shoulder operation | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
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| Skin lesion excision | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
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| Toe amputation | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
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| Tooth extraction | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
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| Aortic stenosis | Vascular disorders | MedDRA | Non-systematic Assessment |
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| Carotid artery stenosis | Vascular disorders | MedDRA | Non-systematic Assessment |
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| Cerebrovascular accident | Vascular disorders | MedDRA | Non-systematic Assessment |
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| Claudication | Vascular disorders | MedDRA | Non-systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA | Non-systematic Assessment |
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| Embolism - blood clot | Vascular disorders | MedDRA | Non-systematic Assessment |
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| Hematoma | Vascular disorders | MedDRA | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
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| Hypertension worsened | Vascular disorders | MedDRA | Non-systematic Assessment |
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| Hypertensive crisis | Vascular disorders | MedDRA | Non-systematic Assessment |
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| Hypertensive urgency | Vascular disorders | MedDRA | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA | Non-systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA | Non-systematic Assessment |
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| Peripheral arterial disease | Vascular disorders | MedDRA | Non-systematic Assessment |
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| Poor peripheral circulation | Vascular disorders | MedDRA | Non-systematic Assessment |
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| Stroke | Vascular disorders | MedDRA | Non-systematic Assessment |
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| Thrombosis | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Transient ischemic attacks | Vascular disorders | MedDRA | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Glassman | JAEB CENTER FOR HEALTH RESEARCH | 8139758690 | mhuggins@jaeb.org |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 24, 2022 | Jan 11, 2023 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 20, 2018 | Nov 28, 2022 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| C533178 | aflibercept |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
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1.25 mg intravitreous bevacizumab + deferred intravitreous 2.0 mg aflibercept if eye meets switch criteria
Bevacizumab + Deferred Aflibercept Group: Bevacizumab is made by Genentech, Inc. and is approved by the FDA for the treatment of metastatic colorectal cancer as well as the treatment of non-squamous non-small cell lung cancer, glioblastoma, and metastatic renal cell carcinoma.
Study eyes assigned to receive bevacizumab will receive a dose of 1.25 mg provided by a single compounding pharmacy identified by the Network and distributed by the Network. The volume of the injections will be 0.05 cc.
Intravitreous injection technique: The injection is preceded by a povidone iodine prep of the conjunctiva. In general, topical antibiotics in the pre-, peri-, or post-injection period should not be used.
The injection will be performed using a sterile technique.
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| Bevacizumab-First Group |
1.25 mg intravitreous bevacizumab + deferred intravitreous 2.0 mg aflibercept if eye meets switch criteria Bevacizumab + Deferred Aflibercept Group: Bevacizumab is made by Genentech, Inc. and is approved by the FDA for the treatment of metastatic colorectal cancer as well as the treatment of non-squamous non-small cell lung cancer, glioblastoma, and metastatic renal cell carcinoma. Study eyes assigned to receive bevacizumab will receive a dose of 1.25 mg provided by a single compounding pharmacy identified by the Network and distributed by the Network. The volume of the injections will be 0.05 cc. Intravitreous injection technique: The injection is preceded by a povidone iodine prep of the conjunctiva. In general, topical antibiotics in the pre-, peri-, or post-injection period should not be used. The injection will be performed using a sterile technique. |
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