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| ID | Type | Description | Link |
|---|---|---|---|
| EY14231 | Other Grant/Funding Number | National Eye Institute | |
| EY23207 | Other Grant/Funding Number | National Eye Institute | |
| EY18817 | Other Grant/Funding Number | National Eye Institute |
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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
| Genentech, Inc. | INDUSTRY |
| National Eye Institute (NEI) | NIH |
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Although anti-vascular endothelial growth factor (VEGF) therapy is generally effective as treatment for center-involved diabetic macular edema (DME), a substantial proportion of anti-VEGF-treated eyes with DME do not achieve vision of 20/20 or complete resolution of retinal thickening. Indeed, over 50% of ranibizumab-treated eyes did not achieve a 2 or more line improvement in visual acuity from baseline at 2 years in Protocol I, a previous DRCR.net (Diabetic Retinopathy Clinical Research Network) study. Furthermore, 27% of ranibizumab-treated eyes still had central subfield (CSF) thickness on time-domain optical coherence tomography (OCT) ≥ 300 at 1 year, and more than 40% of ranibizumab-treated eyes did not achieve complete resolution of retinal thickening (< 250 microns) by 2 years. Thus, there is a need for alternative or additional treatments that will improve vision by reducing retinal edema in eyes with persistent DME following previous anti-VEGF therapy. Intravitreal steroid is not as efficacious as ranibizumab in eyes with DME overall, but it has been shown to have a positive effect for DME in some eyes and might add benefit in eyes that are already receiving anti-VEGF.
The main objective of this study is to assess the short-term effects of combination steroid+anti-VEGF therapy on visual acuity and retinal thickness on OCT in comparison with that of continued anti-VEGF therapy alone in eyes with persistent central-involved DME and visual acuity impairment despite previous anti-VEGF treatment. This study will provide important information for the design of a future confirmatory phase III clinical trial on the efficacy of combination steroid and anti-VEGF in eyes with persistent DME and vision impairment following previous anti-VEGF therapy. The primary outcome for efficacy will be the mean change in visual acuity at 24 weeks.
Each study eye is required to complete a 12-week run-in phase. The run-in phase will identify study eyes that truly have persistent DME despite anti-VEGF therapy by requiring an additional 3 injections while also collecting standardized visual acuity and OCT measurements. At the enrollment, 4-week and 8-week visits of the run-in phase, enrolled eyes will receive an intravitreal injection of ranibizumab 3mg. Then at the 12-week run-in visit, if the eye still has persistent DME, it will be randomized to receive either intravitreal sham+intravitreal ranibizumab 0.3 or intravitreal dexamethasone+intravitreal ranibizumab 0.3 injections. The randomized study duration is 24 week, during which a protocol visit takes place every month. The combination injections of sham+ranibizumab or dexamethasone +ranibizumab will be given at the randomization visit (baseline) and at the 12-week visit after randomization. In between, an intravitreal injection of ranibizumab only will be given to study eyes at the 4, 8, 16 and 20 week visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham + intravitreal ranibizumab 0.3 mg | Active Comparator | Intravitreal ranibizumab will be given on the day of randomization. The sham injection will be given within 0-8 days of the ranibizumab injection. If the injections are given consecutively on the same day, the sham injection must be given first. Follow-up intravitreal injections of ranibizumab will be given up to every 4 weeks using defined treatment criteria. |
|
| Intravitreal dexamethasone+intravitreal ranibizumab 0.3mg | Experimental | The initial intravitreal ranibizumab injection will be given on the day of randomization. The dexamethasone intravitreal injection will be given within 0-8 days of the ranibizumab injection. If defined criteria are met, a second dexamethasone injection in combination with intravitreal ranibizumab (within 0-8 days) will be given at the 12 week visit. If the injections are given consecutively on the same day, the ranibizumab injection must be given first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravitreal ranibizumab 0.3 mg | Drug | Intravitreal injection of 0.3mg ranibizumab performed on the day of randomization and up to every 4 weeks using defined treatment criteria |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Visual Acuity Letter Score | At 24 weeks after randomization, mean change in visual acuity letter score, adjusted for visual acuity at time of randomization | 24 weeks after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| At 24 Weeks After Randomization, Number of Eyes With at Least 10 and at Least 15 Letter Gain (Increase) or Loss (Decrease) in E-ETDRS Letter Score Visual Acuity. | ETDRS (Early Treatment Diabetic Retinopathy Study) | 24 weeks weeks after randomization |
| Visual Acuity Area Under the Curve (AUC) Between Randomization and 24 Weeks |
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Inclusion Criteria:
Age ≥ 18 years i) 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)
Any one of the following will be considered to be sufficient evidence that diabetes is present:
At least one eye meets the study eye criteria listed below.
Fellow eye (if not a study eye) meets criteria.
Able and willing to provide informed consent.
Meets all of the following ocular criteria in at least the one eye:
At least 3 injections of anti-VEGF drug (ranibizumab, bevacizumab, or aflibercept) within the prior 20 weeks.
Visual acuity letter score in study eye ≤ 78 and ≥24 (approximate Snellen equivalent 20/32 to 20/320).
On clinical exam, definite retinal thickening due to DME involving the center of the macula.
OCT CSF thickness, within 8 days of enrollment:
i) On Zeiss Cirrus ≥ 290 microns in women; ≥ 305 in men ii) On Heidelberg Spectralis: ≥ 305 microns in women; ≥ 320 in men
Media clarity, pupillary dilation, and individual cooperation sufficient for adequate OCTs.
Exclusion Criteria:
An individual is not eligible if any of the following exclusion criteria are present:
The following exclusions apply to the study eye only (i.e., they may be present for the non-study eye unless otherwise specified):
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina-Vitreous Associates Medical Group | Beverly Hills | California | 90211 | United States | ||
| Atlantis Eye Care |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29127949 | Result | Maturi RK, Glassman AR, Liu D, Beck RW, Bhavsar AR, Bressler NM, Jampol LM, Melia M, Punjabi OS, Salehi-Had H, Sun JK; Diabetic Retinopathy Clinical Research Network. Effect of Adding Dexamethasone to Continued Ranibizumab Treatment in Patients With Persistent Diabetic Macular Edema: A DRCR Network Phase 2 Randomized Clinical Trial. JAMA Ophthalmol. 2018 Jan 1;136(1):29-38. doi: 10.1001/jamaophthalmol.2017.4914. |
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A 12-week run-in phase was conducted to confirm that eyes with persistent diabetic macular edema (DME) still persisted after additional anti-vascular endothelial growth factor (VEGF) injections. At week 12 of the run-in phase, eyes that had received all run-in injections, and continued to meet specific criteria were eligible for randomization.
Phase 2 multi center randomized trial conducted at 40 US sites; 129 eyes (116 adults) with diabetes between February 2014 and December 2016. Participants with 2 study eyes enrolled one eye in each arm. Therefore, each arm includes no more than 1 study eye per participant; thus the number of eyes is equal to the number of participants in each arm.
| ID | Title | Description |
|---|---|---|
| FG000 | Sham + Intravitreal Ranibizumab 0.3 mg | Intravitreal ranibizumab will be given on the day of randomization. The sham injection will be given within 0-8 days of the ranibizumab injection. If the injections are given consecutively on the same day, the sham injection must be given first. Follow-up intravitreal injections of ranibizumab will be given up to every 4 weeks using defined treatment criteria. intravitreal ranibizumab 0.3 mg: Intravitreal injection of 0.3mg ranibizumab performed on the day of randomization and up to every 4 weeks using defined treatment criteria Sham injection: No injection is given. It is a sham injection to keep the participant masked. The sham injection will be given within 0-8 days of the ranibizumab injection. If the injections are given consecutively on the same day, the sham injection must be given first. |
| 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 |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 25, 2017 | Jun 7, 2018 |
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|
| dexamethasone intravitreal implant | Drug | The dexamethasone intravitreal injection will be given within 0-8 days of the ranibizumab injection. If defined criteria are met, a second dexamethasone injection in combination with intravitreal ranibizumab (within 0-8 days) will be given at the 12 week visit. If the injections are given consecutively on the same day, the ranibizumab injection must be given first. |
|
|
| Sham injection | Procedure | No injection is given. It is a sham injection to keep the participant masked. The sham injection will be given within 0-8 days of the ranibizumab injection. If the injections are given consecutively on the same day, the sham injection must be given first. |
|
Only included participants who completed the 24-week visit. Time points for which data were collected for this analysis include 0, 4 8,12, 16, 20, and 24 weeks post randomization. |
| 24 weeks after randomization |
| Mean Change in OCT CSF Thickness, Adjusted for Thickness at Time of Randomization | Change in optical coherence tomography (OCT) central subfield thickness (in microns) was truncated to 3 standard deviations from the mean [-372, +201] (calculated using observed changes at 24 weeks combining all treatment groups), to minimize the effect of outliers. Two values were truncated in the sham + ranibizumab group: one on the negative end, and one on the positive end. | 24 weeks after randomization |
| Number of Eyes With ≥1 and ≥2 logOCT Step Gain or Loss in CSF Thickness | Change in optical coherence tomography (OCT) central subfield (CSF) thickness (in microns) was truncated to 3 standard deviations from the mean [-372, +201] (calculated using observed changes at 24 weeks combining all treatment groups), to minimize the effect of outliers. Two values were truncated in the sham + ranibizumab group: one on the negative end, and one on the positive end. | 24 weeks after randomization |
| Eyes With OCT CSF Thickness < the Gender-specific Spectral Domain OCT Equivalent of 250 Microns on Zeiss Stratus | Gender and OCT machine-specific values for OCT central subfield thickness (in microns) are defined as: <290 in women and <305 in men in Zeiss Cirrus; <305 in women and <320 in men in Heidelberg Spectralis | 24 weeks after randomization |
| OCT CSF Thickness Area Under the Curve Between Randomization and 24 Weeks | Including participants who completed the 24-week visit. Time points for which data were collected for this analysis include 0, 4 8,12, 16, 20, and 24 weeks post randomization. | 24 weeks after randomization |
| Huntington Beach |
| California |
| 92647 |
| United States |
| Loma Linda University Health Care, Dept. of Ophthalmology | Loma Linda | California | 92354 | United States |
| Northern California Retina Vitreous Associates | Mountain View | California | 94040 | United States |
| Retina Consultants of Southern California | Redlands | California | 92374 | United States |
| Retinal Consultants Medical Group, Inc. | Sacramento | California | 95841 | United States |
| California Retina Consultants | Santa Barbara | California | 93103 | United States |
| Bay Area Retina Associates | Walnut Creek | California | 94598 | United States |
| Retina Group of New England | New London | Connecticut | 06320 | United States |
| New England Retina Associates | Norwich | Connecticut | 06360 | United States |
| National Ophthalmic Research Institute | Fort Myers | Florida | 33912 | United States |
| University of Florida College of Med., Department of Ophthalmology | Jacksonville | Florida | 32209 | United States |
| Central Florida Retina Institute | Lakeland | Florida | 33805 | United States |
| Ocala Eye Retina Consultants | Ocala | Florida | 34474 | United States |
| Sarasota Retina Institute | Sarasota | Florida | 34239 | United States |
| Retina Associates of Florida, P.A. | Tampa | Florida | 33609 | United States |
| Southeast Retina Center, P.C. | Augusta | Georgia | 30909 | United States |
| Thomas Eye Group | Sandy Springs | Georgia | 30328 | United States |
| Raj K. Maturi, M.D., P.C. | Indianapolis | Indiana | 46290 | United States |
| Medical Associates Clinic, P.C. | Dubuque | Iowa | 52002 | United States |
| Wolfe Eye Clinic | West Des Moines | Iowa | 50266 | United States |
| Retina Associates, P.A. | Shawnee Mission | Kansas | 66204 | United States |
| Elman Retina Group, P.A. | Baltimore | Maryland | 21237 | United States |
| National Eye Institute/National Institutes of Health | Bethesda | Maryland | 20892-2510 | United States |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | United States |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
| Retina Vitreous Center | Grand Blanc | Michigan | 48439 | United States |
| Retina Specialists of Michigan | Grand Rapids | Michigan | 49525 | United States |
| Retina Center, PA | Minneapolis | Minnesota | 55404 | United States |
| The Retina Institute | St Louis | Missouri | 63128 | United States |
| The Institute of Ophthalmology and Visual Science (IOVS) | Newark | New Jersey | 07103 | United States |
| MaculaCare | New York | New York | 10021 | United States |
| Retina Associates of Western New York | Rochester | New York | 14618 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Charlotte Eye Ear Nose and Throat Assoc, PA | Charlotte | North Carolina | 28210 | United States |
| Retina Associates of Cleveland, Inc. | Beachwood | Ohio | 44122 | United States |
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| Retina Northwest, PC | Portland | Oregon | 97210 | United States |
| Casey Eye Institute | Portland | Oregon | 97239 | United States |
| University of Pennsylvania Scheie Eye Institute | Philadelphia | Pennsylvania | 19104 | United States |
| Southeastern Retina Associates, P.C. | Knoxville | Tennessee | 37909 | United States |
| Southwest Retina Specialists | Amarillo | Texas | 79106 | United States |
| Austin Retina Associates | Austin | Texas | 78705 | United States |
| Retina Research Center | Austin | Texas | 78705 | United States |
| Retina and Vitreous of Texas | Houston | Texas | 77025 | 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 |
| Retina Associates of Utah, P.C. | Salt Lake City | Utah | 84107 | United States |
| Virginia Retina Center | Leesburg | Virginia | 20176 | United States |
| Retina Institute of Virginia | Richmond | Virginia | 23235 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| Spokane Eye Clinic | Spokane | Washington | 99204 | United States |
| University of Wisconsin-Madison, Dept of Ophthalmology/Retina Service | Madison | Wisconsin | 53705 | United States |
| FG001 | Intravitreal Dexamethasone+Intravitreal Ranibizumab 0.3mg | The initial intravitreal ranibizumab injection will be given on the day of randomization. The dexamethasone intravitreal injection will be given within 0-8 days of the ranibizumab injection. If defined criteria are met, a second dexamethasone injection in combination with intravitreal ranibizumab (within 0-8 days) will be given at the 12 week visit. If the injections are given consecutively on the same day, the ranibizumab injection must be given first. intravitreal ranibizumab 0.3 mg: Intravitreal injection of 0.3mg ranibizumab performed on the day of randomization and up to every 4 weeks using defined treatment criteria. Dexamethasone intravitreal implant: The dexamethasone intravitreal injection will be given within 0-8 days of the ranibizumab injection. If defined criteria are met, a second dexamethasone injection in combination with intravitreal ranibizumab (within 0-8 days) will be given at the 12 week visit. If the injections are given consecutively on the same day, the ran |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Units in Eyes
| ID | Title | Description |
|---|---|---|
| BG000 | Sham + Intravitreal Ranibizumab 0.3 mg | Sham and ranibizumab, 0.3 mg, injections |
| BG001 | Intravitreal Dexamethasone+Intravitreal Ranibizumab 0.3mg | Combination of ranibizumab, 0.3 mg and intravitreous sustained dexamethasone drug-delivery system (Ozurdex; Allergan), 700 µg, injection |
| 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 | Median | Inter-Quartile Range | years | Eyes |
| ||||||||||||||
| Sex/Gender, Customized | Count of Units | Eyes | Eyes |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Units | Eyes | Eyes |
| |||||||||||||||
| Diabetes Type | Count of Units | Eyes | Eyes |
| |||||||||||||||
| Duration of Diabetes | Median | Inter-Quartile Range | years | Eyes |
| ||||||||||||||
| Insulin Used | Count of Participants | Participants | Participants |
| |||||||||||||||
| Hemoglobin A1c | Median | Inter-Quartile Range | Percent Hemoglobin | Eyes |
| ||||||||||||||
| Arterial Blood Pressure | Median | Inter-Quartile Range | mmHg | Eyes |
| ||||||||||||||
| Smoking status | Count of Units | Eyes | Eyes |
| |||||||||||||||
| Body Mass Index | Median | Inter-Quartile Range | kg/m˄2 | Eyes |
| ||||||||||||||
| Participants with 2 study eyes | Number | participants | Eyes |
| |||||||||||||||
| Prior macular laser treatment for DME | Number | Eyes | Eyes |
| |||||||||||||||
| Prior Anti-VEGF for DME | Number | Eyes | Eyes |
| |||||||||||||||
| Total anti-VEGF injections for DME within the 20 weeks before run-in phase | Median | Inter-Quartile Range | Injections | Eyes |
| ||||||||||||||
| Randomization visual acuity letter score | Best-corrected visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the early treatment diabetic retinopathy study method . Best value on the scale 97, worst 0. | Mean | Standard Deviation | units on a scale | Eyes |
| |||||||||||||
| Randomization central subfield thickness | on optical coherence tomography | Mean | Standard Deviation | Microns | Eyes |
| |||||||||||||
| Change in central subfield thickness from enrollment to randomization | Mean | Standard Deviation | Microns | Eyes |
| ||||||||||||||
| Improvement in visual acuity(VA) and OCT CST thickness during run-in phase | OCT = Optical coherence tomography CST = Central Subfield Thickness | Number | Eyes | Eyes |
| ||||||||||||||
| Randomization retinal volume | Mean | Standard Deviation | mm3 | Eyes |
| ||||||||||||||
| Randomization diabetic retinopathy severity level on clinical examination | PDR= Proliferative diabetic retinopathy; NPDR= Non-proliferative diabetic retinopathy | Number | Eyes | Eyes |
| ||||||||||||||
| Change in visual acuity letter score from enrollment to randomization | Best-corrected visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the early treatment diabetic retinopathy study method. Best value on the scale 97, worst 0. | Mean | Standard Deviation | units on a scale | 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 Letter Score | At 24 weeks after randomization, mean change in visual acuity letter score, adjusted for visual acuity at time of randomization | Posted | Mean | Standard Deviation | Letter Score | 24 weeks after randomization | Eyes | Eyes |
|
|
| |||||||||||||||||||||||||||||
| Secondary | At 24 Weeks After Randomization, Number of Eyes With at Least 10 and at Least 15 Letter Gain (Increase) or Loss (Decrease) in E-ETDRS Letter Score Visual Acuity. | ETDRS (Early Treatment Diabetic Retinopathy Study) | Posted | Number | Eyes | 24 weeks weeks after randomization | Eyes | Eyes |
| ||||||||||||||||||||||||||||||||
| Secondary | Visual Acuity Area Under the Curve (AUC) Between Randomization and 24 Weeks | Only included participants who completed the 24-week visit. Time points for which data were collected for this analysis include 0, 4 8,12, 16, 20, and 24 weeks post randomization. | Posted | Mean | Standard Deviation | Letter Score | 24 weeks after randomization | Eyes | Eyes |
| |||||||||||||||||||||||||||||||
| Secondary | Mean Change in OCT CSF Thickness, Adjusted for Thickness at Time of Randomization | Change in optical coherence tomography (OCT) central subfield thickness (in microns) was truncated to 3 standard deviations from the mean [-372, +201] (calculated using observed changes at 24 weeks combining all treatment groups), to minimize the effect of outliers. Two values were truncated in the sham + ranibizumab group: one on the negative end, and one on the positive end. | Posted | Mean | Standard Deviation | microns | 24 weeks after randomization | Eyes | Eyes |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Eyes With ≥1 and ≥2 logOCT Step Gain or Loss in CSF Thickness | Change in optical coherence tomography (OCT) central subfield (CSF) thickness (in microns) was truncated to 3 standard deviations from the mean [-372, +201] (calculated using observed changes at 24 weeks combining all treatment groups), to minimize the effect of outliers. Two values were truncated in the sham + ranibizumab group: one on the negative end, and one on the positive end. | Posted | Number | Eyes | 24 weeks after randomization | Eyes | Eyes |
| ||||||||||||||||||||||||||||||||
| Secondary | Eyes With OCT CSF Thickness < the Gender-specific Spectral Domain OCT Equivalent of 250 Microns on Zeiss Stratus | Gender and OCT machine-specific values for OCT central subfield thickness (in microns) are defined as: <290 in women and <305 in men in Zeiss Cirrus; <305 in women and <320 in men in Heidelberg Spectralis | Posted | Number | Eyes | 24 weeks after randomization | Eyes | Eyes |
| ||||||||||||||||||||||||||||||||
| Secondary | OCT CSF Thickness Area Under the Curve Between Randomization and 24 Weeks | Including participants who completed the 24-week visit. Time points for which data were collected for this analysis include 0, 4 8,12, 16, 20, and 24 weeks post randomization. | Posted | Mean | Standard Deviation | microns | 24 weeks after randomization | Eyes | Eyes |
|
From Randomization to 24-weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intravitreal Dexamethasone+Intravitreal Ranibizumab 0.3mg | The initial intravitreal ranibizumab injection will be given on the day of randomization. The dexamethasone intravitreal injection will be given within 0-8 days of the ranibizumab injection. If defined criteria are met, a second dexamethasone injection in combination with intravitreal ranibizumab (within 0-8 days) will be given at the 12 week visit. If the injections are given consecutively on the same day, the ranibizumab injection must be given first. Intravitreal ranibizumab 0.3 mg: Intravitreal injection of 0.3mg ranibizumab performed on the day of randomization and up to every 4 weeks using defined treatment criteria dexamethasone intravitreal implant: The dexamethasone intravitreal injection will be given within 0-8 days of the ranibizumab injection. If defined criteria are met, a second dexamethasone injection in combination with intravitreal ranibizumab (within 0-8 days) will be given at the 12 week visit. If the injections are given consecutively on the same day, the ran | 0 | 52 | 7 | 52 | 38 | 52 |
| EG001 | Sham + Intravitreal Ranibizumab 0.3 mg | Intravitreal ranibizumab will be given on the day of randomization. The sham injection will be given within 0-8 days of the ranibizumab injection. If the injections are given consecutively on the same day, the sham injection must be given first. Follow-up intravitreal injections of ranibizumab will be given up to every 4 weeks using defined treatment criteria. intravitreal ranibizumab 0.3 mg: Intravitreal injection of 0.3mg ranibizumab performed on the day of randomization and up to every 4 weeks using defined treatment criteria Sham injection: No injection is given. It is a sham injection to keep the participant masked. The sham injection will be given within 0-8 days of the ranibizumab injection. If the injections are given consecutively on the same day, the sham injection must be given first. | 0 | 51 | 7 | 51 | 29 | 52 |
| EG002 | Bilateral | Participants with one eye enrolled in each arm of the study. A participant could only have one eye in each arm/group, therefore participants in the bilateral group received Intravitreal dexamethasone+intravitreal ranibizumab 0.3mg in one eye and Sham + intravitreal ranibizumab 0.3 mg in the other eye. | 0 | 13 | 1 | 13 | 11 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diastolic dysfunction | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hypoglycaemia | Endocrine disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cataract subcapsular | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Multiple fractures | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Stent placement | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Vascular graft | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cerebrovascular accident | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Diabetes mellitus inadequate control | Endocrine disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hypoglycaemia | Endocrine disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Asthenopia | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cataract cortical | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cataract nuclear | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cataract subcapsular | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Corneal defect | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Corneal oedema | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Ectropion | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Eyelid ptosis | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Foreign body sensation in eyes | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Iritis | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Metamorphopsia | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Ocular discomfort | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Retinal exudates | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Visual field defect | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Vitreous adhesions | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gastroenteritis viral | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Tooth infection | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Foot fracture | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gout | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Multiple fractures | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Rib fracture | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Carotid artery occlusion | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Myasthenia gravis | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Urinary tract infection | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pharyngitis streptococcal | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Basal cell carcinoma | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Skin cancer | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Skin infection | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Knee operation | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
Trial results can not be discussed until they have been made available to the public
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Glassman | Jaeb Center for Health Research | 8139758690 | drcrnet@jaeb.org |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Nov 16, 2015 | Jun 7, 2018 | Prot_001.pdf |
| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| C005703 | salicylhydroxamic acid |
| 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 |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
Not provided
Not provided
| Male |
|
| Black/African American |
|
| Hispanic or Latino |
|
| Asian |
|
| Native Hawaiian or other Pacific Islander |
|
| Unknown/not reported |
|
| Type 2 |
|
| Uncertain |
|
| Prior |
|
| Current |
|
| Bevacizumab only |
|
| Ranibizumab only |
|
| Both aflibercept and bevacizumab |
|
| Both aflibercept and ranibizumab |
|
| Both bevacizumab and ranibizumab |
|
| VA and OCT CST are both improved |
|
| VA is not improved but OCT CST is improved |
|
| VA is improved but OCT CST is not improved |
|
| Severe NPDR |
|
| PDR and/or prior scatter laser |
|
|
|
|
|
| Sham + Intravitreal Ranibizumab 0.3 mg |
Intravitreal ranibizumab will be given on the day of randomization. The sham injection will be given within 0-8 days of the ranibizumab injection. If the injections are given consecutively on the same day, the sham injection must be given first. Follow-up intravitreal injections of ranibizumab will be given up to every 4 weeks using defined treatment criteria. intravitreal ranibizumab 0.3 mg: Intravitreal injection of 0.3mg ranibizumab performed on the day of randomization and up to every 4 weeks using defined treatment criteria Sham injection: No injection is given. It is a sham injection to keep the participant masked. The sham injection will be given within 0-8 days of the ranibizumab injection. If the injections are given consecutively on the same day, the sham injection must be given first. |
|
|
Intravitreal ranibizumab will be given on the day of randomization. The sham injection will be given within 0-8 days of the ranibizumab injection. If the injections are given consecutively on the same day, the sham injection must be given first. Follow-up intravitreal injections of ranibizumab will be given up to every 4 weeks using defined treatment criteria. intravitreal ranibizumab 0.3 mg: Intravitreal injection of 0.3mg ranibizumab performed on the day of randomization and up to every 4 weeks using defined treatment criteria Sham injection: No injection is given. It is a sham injection to keep the participant masked. The sham injection will be given within 0-8 days of the ranibizumab injection. If the injections are given consecutively on the same day, the sham injection must be given first. |
|
|
|
|
|
|