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The purpose of this research study is to determine if a "Treat and Extend" regimen (increasing the time between visits when the disease is stable and not getting worse) of Ranibizumab 0.3 mg injections inside the eye is safe and effective at treating patients with swelling of the retina from diabetes.
This research study will compare the visual outcomes between a group of patients who are treated with monthly injections of Ranibizumab 0.3 mg and two groups of patients who are treated with the "Treat and Extend" regimen. One of the "Treat and Extend" groups will also receive laser therapy to determine if this has any additional beneficial effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monthly | Active Comparator | Monthly Cohort (30 eyes) - Study eyes will receive intravitreal injections of 0.3 mg ranibizumab every 4 weeks for 24 months. |
|
| TREX | Active Comparator | (60 eyes) - Monthly intravitreal injections of 0.3 mg ranibizumab for four visits. At the fourth visit (Week 12), if the central foveal thickness is ≤ 325 μm then the eye will receive 0.3 mg ranibizumab and begin the extension phase of the study. For all subsequent visits in the extension phase, appropriate changes to the treatment interval with 0.3 mg ranibizumab (i.e. extend, maintain, reduce) will be made based on pre-specified SD (Spectral Domain)-OCT criteria. Treatment is rendered at every visit. The time between visits is individualized based on each subject's response to treatment. If the central foveal thickness is > 325 μm at week 12, then the patient will continue to receive monthly intravitreal injections of 0.3 mg ranibizumab until the central foveal thickness is ≤ 325 μm. Once the central foveal thickness is ≤ 325 μm, then the study eye will begin the extension phase of the study. |
|
| GILA | Active Comparator | (60 eyes) - Monthly intravitreal injections of 0.3 mg ranibizumab for four visits combined with guided laser photocoagulation to all microaneurysms in the area of DME at visit 2 (Week 4) and then again every 3 months, if leakage is present on fluorescein angiography. If the central foveal thickness is ≤ 325 μm at visit 4 (Week 12), eyes will receive 0.3 mg ranibizumab and the extension phase will begin. For all subsequent visits in the extension phase, appropriate changes to the treatment interval with 0.3 mg ranibizumab (i.e. extend, maintain, reduce) will be made based on pre-specified SD-Optical coherence tomography criteria. If the central foveal thickness is > 325 μm at week 12, then the patient will continue to receive monthly intravitreal injections of 0.3 mg ranibizumab and possible guided laser every 3 months until the central foveal thickness is ≤ 325 μm. Once the central foveal thickness is ≤ 325 μm, then the study eye will begin the extension phase of the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab 0.3 mg intravitreal injection | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Vision at 24 Months | Mean change in ETDRS (Early Treatment in Diabetic Retinopathy Study) visual acuity at 24 months (week 92-week 107) from Day 0. Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard. A higher letter score represents better functioning" | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Number of Participants with Adverse Events, ocular and non-ocular, in each of the study groups | 2 years |
| Number of Intravitreal Injections | Total number of intravitreal injections required during the first 12 months (week 46 - week 57) and the entire 24-month (week 92 - week 107) study period. |
Not provided
Inclusion Criteria:
Disease related considerations
Exclusion Criteria:
General Exclusion Criteria
Ocular Exclusion Criteria Prior Ocular Treatment
Concurrent Ocular Conditions
• Any concurrent intraocular condition in the study eye (e.g., cataract or macular degeneration) that, in the opinion of the investigator, could either: Require medical or surgical intervention during the 24-month study period to prevent or treat visual loss that might result from that condition; or if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA (Best Corrected Visual Acuity) over the 24-month study period.
Concurrent Systemic Conditions
A woman is considered not to be of childbearing potential if she is postmenopausal, defined by amenorrhea for at least 1 year in a woman > 45 years old; or has undergone hysterectomy and/or bilateral oophorectomy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina-Vitreous Associates Medical Group | Beverly Hills | California | 90211 | United States | ||
| Palmetto Retina Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32303499 | Derived | Payne JF, Wykoff CC, Clark WL, Bruce BB, Boyer DS, Brown DM; TREX-DME Study Group. Long-term outcomes of treat-and-extend ranibizumab with and without navigated laser for diabetic macular oedema: TREX-DME 3-year results. Br J Ophthalmol. 2021 Feb;105(2):253-257. doi: 10.1136/bjophthalmol-2020-316176. Epub 2020 Apr 17. | |
| 29729809 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Monthly | Monthly Cohort (30 eyes) - Study eyes will receive intravitreal injections of 0.3 mg ranibizumab every 4 weeks for 24 months. |
| FG001 | TREX | (60 eyes) - Monthly intravitreal injections of 0.3 mg ranibizumab for four visits and then underwent a treat and extend protocol of ranibizumab without navigated laser therapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 23, 2015 |
Not provided
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|
| Guided Laser Photocoagulation | Device |
|
|
| 2 years |
| Number of Office Visits | Total number of office visits and imaging studies performed during the first 12 months (week 46 - week 57) and the entire 24-month (week 92 - week 107) study period. | 2 years |
| Change in Retinal Thickness | Mean change in central foveal thickness per SDOCT (Spectral Domain Optical Coherence Tomography) from randomization to 12 months (week46 - week 57) and randomization to 24 months (week 92 - week 107) study period.Change at month 24 reported. | 2 years |
| Percentage of Eyes Gaining or Losing Vision | Percentage of eyes gaining or losing 3 lines of vision or more and 1 line of vision at 24 months (week 92 - week 107) from Day 0. | 2 years |
| Percentage of Eyes Which Progress to Proliferative Diabetic Retinopathy | The percentage of eyes which show progression of proliferative diabetic retinopathy requiring panretinal photocoagulation and/or pars plana vitrectomy over the 24-month study period. | 2 years |
| Percentage of Eyes Able to Begin Extension Phase Prior to Week 104 End-point Visit. | The percentage of eyes in the TREX (Treat and Extend) and GILA (Guided Laser) cohorts who are eligible to begin the extension phase prior to week 104 end-point visit. | 2 years |
| Percentage of Eyes With a Secondary or Tertiary Baseline Retinal Thickness | For TREX and GILA Cohorts, the time to achieve a "Secondary or Tertiary Baseline" retinal thickness. | 2 years |
| West Columbia |
| South Carolina |
| 29169 |
| United States |
| Retina Consultants of Houston | Houston | Texas | 77030 | United States |
| Payne JF, Clark WL, Bruce BB, Wykoff CC, Brown DM, Menke BM, Iverson SM, Allen KF, Boyer DS; Treat & Extend Protocol in Patients with Diabetic Macular Edema Study Group. Retinopathy Regression with Treat and Extend Ranibizumab for Diabetic Macular Edema. Ophthalmology. 2018 Aug;125(8):1304-1306. doi: 10.1016/j.ophtha.2018.03.046. Epub 2018 May 3. No abstract available. |
| 27836430 | Derived | Payne JF, Wykoff CC, Clark WL, Bruce BB, Boyer DS, Brown DM; TREX-DME Study Group. Randomized Trial of Treat and Extend Ranibizumab with and without Navigated Laser for Diabetic Macular Edema: TREX-DME 1 Year Outcomes. Ophthalmology. 2017 Jan;124(1):74-81. doi: 10.1016/j.ophtha.2016.09.021. Epub 2016 Nov 8. |
| FG002 | GILA | (60 eyes) - Monthly intravitreal injections of 0.3 mg ranibizumab for four visits and then underwent a treat and extend protocol of ranibizumab with navigated laser therapy. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| ID | Title | Description |
|---|---|---|
| BG000 | Monthly | Monthly Cohort (30 eyes) - Study eyes will receive intravitreal injections of 0.3 mg ranibizumab every 4 weeks for 24 months. Ranibizumab 0.3 mg intravitreal injection |
| BG001 | TREX | (60 eyes) - Monthly intravitreal injections of 0.3 mg ranibizumab for four visits. At the fourth visit (Week 12), if the central foveal thickness is ≤ 325 μm then the eye will receive 0.3 mg ranibizumab and begin the extension phase of the study. For all subsequent visits in the extension phase, appropriate changes to the treatment interval with 0.3 mg ranibizumab (i.e. extend, maintain, reduce) will be made based on pre-specified SD (Spectral Domain)-OCT criteria. Treatment is rendered at every visit. The time between visits is individualized based on each subject's response to treatment. If the central foveal thickness is > 325 μm at week 12, then the patient will continue to receive monthly intravitreal injections of 0.3 mg ranibizumab until the central foveal thickness is ≤ 325 μm. Once the central foveal thickness is ≤ 325 μm, then the study eye will begin the extension phase of the study. Ranibizumab 0.3 mg intravitreal injection |
| BG002 | GILA | (60 eyes) - Monthly intravitreal injections of 0.3 mg ranibizumab for four visits combined with guided laser photocoagulation to all microaneurysms in the area of DME at visit 2 (Week 4) and then again every 3 months, if leakage is present on fluorescein angiography. If the central foveal thickness is ≤ 325 μm at visit 4 (Week 12), eyes will receive 0.3 mg ranibizumab and the extension phase will begin. For all subsequent visits in the extension phase, appropriate changes to the treatment interval with 0.3 mg ranibizumab (i.e. extend, maintain, reduce) will be made based on pre-specified SD-Optical coherence tomography criteria. If the central foveal thickness is > 325 μm at week 12, then the patient will continue to receive monthly intravitreal injections of 0.3 mg ranibizumab and possible guided laser every 3 months until the central foveal thickness is ≤ 325 μm. Once the central foveal thickness is ≤ 325 μm, then the study eye will begin the extension phase of the study. |
| BG003 | 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, Continuous | Median | Inter-Quartile Range | Years | Participants |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants | Participants |
| |||||||||||||||
| Body-Mass Index | Median | Inter-Quartile Range | Units of measure "kg/m^2" | Participants |
| ||||||||||||||
| Mean Duration of Diabetes | Mean | Inter-Quartile Range | Years | Participants |
| ||||||||||||||
| Phakic Status | Number | participants | Participants |
| |||||||||||||||
| Mean Best Corrected Visual Acuity (ETDRS Letters) | Best Corrected Visual Acuity (BCVA) was measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score starting at 4 meters. More letters read correctly results in a higher letter score, which represents better visual acuity | Mean | Inter-Quartile Range | units on a scale | Participants |
| |||||||||||||
| Central Retinal Thickness (microns) | The Central Retinal Thickness is measured using an OCT machine which scans the retina. The Lower number of microns is better | Number | Microns | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change in Vision at 24 Months | Mean change in ETDRS (Early Treatment in Diabetic Retinopathy Study) visual acuity at 24 months (week 92-week 107) from Day 0. Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard. A higher letter score represents better functioning" | For those lost to follow-up, last observation carried forward | Posted | Median | Inter-Quartile Range | units on a scale | 2 Years |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events | Number of Participants with Adverse Events, ocular and non-ocular, in each of the study groups | Posted | Count of Participants | Participants | 2 years |
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Intravitreal Injections | Total number of intravitreal injections required during the first 12 months (week 46 - week 57) and the entire 24-month (week 92 - week 107) study period. | Multiple imputation model for eyes lost to follow-up prior to week 104 visit. | Posted | Median | Inter-Quartile Range | Injections | 2 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Office Visits | Total number of office visits and imaging studies performed during the first 12 months (week 46 - week 57) and the entire 24-month (week 92 - week 107) study period. | Multiple imputation model for eyes not reaching week 104 end-point visit. | Posted | Median | Inter-Quartile Range | Visits | 2 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Change in Retinal Thickness | Mean change in central foveal thickness per SDOCT (Spectral Domain Optical Coherence Tomography) from randomization to 12 months (week46 - week 57) and randomization to 24 months (week 92 - week 107) study period.Change at month 24 reported. | For those not reaching week 104 end-point, last observation carried forward | Posted | Median | Inter-Quartile Range | Microns | 2 years |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Eyes Gaining or Losing Vision | Percentage of eyes gaining or losing 3 lines of vision or more and 1 line of vision at 24 months (week 92 - week 107) from Day 0. | Posted | Count of Units | Eyes | 2 years | Eyes | Eyes |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Eyes Which Progress to Proliferative Diabetic Retinopathy | The percentage of eyes which show progression of proliferative diabetic retinopathy requiring panretinal photocoagulation and/or pars plana vitrectomy over the 24-month study period. | Posted | Count of Units | Eyes | 2 years | Eyes | Eyes |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Eyes Able to Begin Extension Phase Prior to Week 104 End-point Visit. | The percentage of eyes in the TREX (Treat and Extend) and GILA (Guided Laser) cohorts who are eligible to begin the extension phase prior to week 104 end-point visit. | Posted | Count of Units | Eyes | 2 years | Eyes | Eyes |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Eyes With a Secondary or Tertiary Baseline Retinal Thickness | For TREX and GILA Cohorts, the time to achieve a "Secondary or Tertiary Baseline" retinal thickness. | Posted | Count of Units | Eyes | 2 years | Eyes | Eyes |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Monthly | Monthly Cohort (30 eyes) - Study eyes will receive intravitreal injections of 0.3 mg ranibizumab every 4 weeks for 24 months. Ranibizumab 0.3 mg intravitreal injection | 1 | 30 | 11 | 30 | 30 | 30 |
| EG001 | TREX | (60 eyes) - Monthly intravitreal injections of 0.3 mg ranibizumab for four visits. At the fourth visit (Week 12), if the central foveal thickness is ≤ 325 μm then the eye will receive 0.3 mg ranibizumab and begin the extension phase of the study. For all subsequent visits in the extension phase, appropriate changes to the treatment interval with 0.3 mg ranibizumab (i.e. extend, maintain, reduce) will be made based on pre-specified SD (Spectral Domain)-OCT criteria. Treatment is rendered at every visit. The time between visits is individualized based on each subject's response to treatment. If the central foveal thickness is > 325 μm at week 12, then the patient will continue to receive monthly intravitreal injections of 0.3 mg ranibizumab until the central foveal thickness is ≤ 325 μm. Once the central foveal thickness is ≤ 325 μm, then the study eye will begin the extension phase of the study. Ranibizumab 0.3 mg intravitreal injection | 5 | 60 | 30 | 60 | 60 | 60 |
| EG002 | GILA | (60 eyes) - Monthly intravitreal injections of 0.3 mg ranibizumab for four visits combined with guided laser photocoagulation to all microaneurysms in the area of DME at visit 2 (Week 4) and then again every 3 months, if leakage is present on fluorescein angiography. If the central foveal thickness is ≤ 325 μm at visit 4 (Week 12), eyes will receive 0.3 mg ranibizumab and the extension phase will begin. For all subsequent visits in the extension phase, appropriate changes to the treatment interval with 0.3 mg ranibizumab (i.e. extend, maintain, reduce) will be made based on pre-specified SD-Optical coherence tomography criteria. If the central foveal thickness is > 325 μm at week 12, then the patient will continue to receive monthly intravitreal injections of 0.3 mg ranibizumab and possible guided laser every 3 months until the central foveal thickness is ≤ 325 μm. Once the central foveal thickness is ≤ 325 μm, then the study eye will begin the extension phase of the study. | 2 | 60 | 46 | 60 | 60 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vitreous Hemorrhage | Eye disorders | Vitreous Hemorrhage | Systematic Assessment | Vitreous Hemorrhage |
|
| Myocardial Infarction | Cardiac disorders | Myocardial Infarctio | Systematic Assessment | Myocardial Infarction |
|
| Angina Pectoris | Cardiac disorders | Angina Pectoris | Systematic Assessment | Angina Pectoris |
|
| Cardiac Arrhythmia | Cardiac disorders | Cardiac Arrhythmia | Systematic Assessment | Cardiac Arrhythmia |
|
| Cardiomyopathy | Cardiac disorders | Cardiomyopathy | Systematic Assessment | Cardiomyopathy |
|
| Congestive Heart Failure | Cardiac disorders | Heart Failure | Systematic Assessment | Congestive Heart Failure |
|
| Coronary Artery Disease | Cardiac disorders | Coronary Art Disease | Systematic Assessment | Coronary Artery Disease |
|
| Pericardial Effusion | Cardiac disorders | Pericardial Effusion | Systematic Assessment | Pericardial Effusion |
|
| Gallstones | Hepatobiliary disorders | Gallstones | Systematic Assessment | Gallstones |
|
| Hematoma | Blood and lymphatic system disorders | Hematoma | Systematic Assessment | Hematoma |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Thrombocytopenia | Systematic Assessment | Thrombocytopenia |
|
| Allergy | Immune system disorders | Allergy | Systematic Assessment | Allergy |
|
| Appendicitis | Gastrointestinal disorders | Appendicitis | Systematic Assessment | Appendicitis |
|
| Gastrointestinal Infection | Infections and infestations | GI Infection | Systematic Assessment | Gastrointestinal Infection |
|
| Parotitis | Infections and infestations | Parotitis | Systematic Assessment | Parotitis |
|
| Respiratory Infection | Infections and infestations | Resp Infection | Systematic Assessment | Respiratory Infection |
|
| Skin/Soft Tissue Infection | Infections and infestations | Skin/ST Infection | Systematic Assessment | Skin/Soft Tissue Infection |
|
| Urinary Tract Infection | Infections and infestations | UTI | Systematic Assessment | Urinary Tract Infection |
|
| Elevated Creatinine | Metabolism and nutrition disorders | Elevated Creatinine | Systematic Assessment | Elevated Creatinine |
|
| Hyperammonemia | Metabolism and nutrition disorders | Hyperammonemia | Systematic Assessment | Hyperammonemia |
|
| Hypo/Hyperglycemia | Endocrine disorders | Hypo/Hyperglycemia | Systematic Assessment | Hypo/Hyperglycemia |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Arthritis | Systematic Assessment | Osteoarthritis |
|
| Fractured Bone | Injury, poisoning and procedural complications | Fractured Bone | Systematic Assessment | Fractured Bone |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | Pain | Systematic Assessment | Musculoskeletal Pain |
|
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Colon Cancer | Systematic Assessment | Colon Cancer |
|
| Lung Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Lung Cancer | Systematic Assessment | Lung Cancer |
|
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Prostate Cancer | Systematic Assessment | Prostate Cancer |
|
| Cranial Nerve Palsy | Nervous system disorders | Cranial Nerve Palsy | Systematic Assessment | Cranial Nerve Palsy |
|
| Cerebrovascular Accident | Nervous system disorders | CVA | Systematic Assessment | Cerebrovascular Accident |
|
| Syncope | Nervous system disorders | Syncope | Systematic Assessment | Syncope |
|
| Transient Ischemic Attack | Nervous system disorders | TIA | Systematic Assessment | Transient Ischemic Attack |
|
| Urolithiasis | Renal and urinary disorders | Kidney Stones | Systematic Assessment | Urolithiasis |
|
| Renal Failure | Renal and urinary disorders | Renal Failure | Systematic Assessment | Renal Failure |
|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Resp Failure | Systematic Assessment | Acute Respiratory Failure |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Dyspnea | Systematic Assessment | Dyspnea |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Pneumonia | Systematic Assessment | Pneumonia |
|
| Orthostatic Hypotension | Vascular disorders | Orth Hypotension | Systematic Assessment | Orthostatic Hypotension |
|
| Hypertension | Vascular disorders | Hypertension | Systematic Assessment | Hypertension |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blurred Vision/Vision Loss | Eye disorders | Blurred Vision | Systematic Assessment | Blurred Vision/Vision Loss |
|
| Cataract Progression | Eye disorders | Cataract Progression | Systematic Assessment | Cataract Progression |
|
| Chalazion | Eye disorders | Chalazion | Systematic Assessment | Chalazion |
|
| Elevated Intraocular Pressure | Eye disorders | Elevated IOP | Systematic Assessment | Elevated Intraocular Pressure |
|
| Eye Discomfort/Discharge | Eye disorders | Eye Pain | Systematic Assessment | Eye Discomfort/Discharge |
|
| Eyelid Swelling | Eye disorders | Eyelid Swelling | Systematic Assessment | Eyelid Swelling |
|
| Secondary Cataract | Eye disorders | Secondary Cataract | Systematic Assessment | Secondary Cataract |
|
| Vitreous Floaters | Eye disorders | Floaters | Systematic Assessment | Vitreous Floaters |
|
| Punctate Keratitis | Eye disorders | Punctate Keratitis | Systematic Assessment | Punctate Keratitis |
|
| Vitreous Hemorrhage | Eye disorders | Vitreous Hemorrhage | Systematic Assessment | Vitreous Hemorrhage |
|
| Myocardial Infarction | Cardiac disorders | Myocardial Infarctio | Systematic Assessment | Myocardial Infarction |
|
| Angina Pectoris | Cardiac disorders | Angina Pectoris | Systematic Assessment | Angina Pectoris |
|
| Cardiac Arrhythmia | Cardiac disorders | Arrhythmia | Systematic Assessment | Cardiac Arrhythmia |
|
| Congestive Heart Failure | Cardiac disorders | Heart Failure | Systematic Assessment | Congestive Heart Failure |
|
| Peripheral Edema | Vascular disorders | Peripheral Edema | Systematic Assessment | Peripheral Edema |
|
| Diarrhea | Gastrointestinal disorders | Diarrhea | Systematic Assessment | Diarrhea |
|
| Gallstones | Hepatobiliary disorders | Gallstones | Systematic Assessment | Gallstones |
|
| Esophageal Reflux | Gastrointestinal disorders | Esophageal Reflux | Systematic Assessment | Esophageal Reflux |
|
| Poor Dentition | General disorders | Poor Dentition | Systematic Assessment | Poor Dentition |
|
| Throat Irritation | Gastrointestinal disorders | Throat Irritation | Systematic Assessment | Throat Irritation |
|
| Anemia | Blood and lymphatic system disorders | Anemia | Systematic Assessment | Anemia |
|
| Allergy | Immune system disorders | Allergy | Systematic Assessment | Allergy |
|
| Fever | Infections and infestations | Fever | Systematic Assessment | Fever |
|
| Gastrointestinal Infection | Infections and infestations | GI Infection | Systematic Assessment | Gastrointestinal Infection |
|
| Skin Infection | Infections and infestations | Skin Infection | Systematic Assessment | Skin Infection |
|
| Respiratory Infection | Infections and infestations | Resp Infection | Systematic Assessment | Respiratory Infection |
|
| Sinusitis | Infections and infestations | Sinusitis | Systematic Assessment | Sinusitis |
|
| Urinary Tract Infection | Infections and infestations | UTI | Systematic Assessment | Urinary Tract Infection |
|
| Fatigue | General disorders | Fatigue | Systematic Assessment | Fatigue |
|
| Hypo/Hyperglycemia | Endocrine disorders | Hypo/Hyperglycemia | Systematic Assessment | Hypo/Hyperglycemia |
|
| Hyperlipidemia | Metabolism and nutrition disorders | Hyperlipidemia | Systematic Assessment | Hyperlipidemia |
|
| Hypo/Hyperkalemia | Metabolism and nutrition disorders | Hypo/Hyperkalemia | Systematic Assessment | Hypo/Hyperkalemia |
|
| Testosterone Deficiency | Endocrine disorders | Testosterone Def | Systematic Assessment | Testosterone Deficiency |
|
| Vitamin D Deficiency | Metabolism and nutrition disorders | Vit D Deficiency | Systematic Assessment | Vitamin D Deficiency |
|
| Fractured Bone | Injury, poisoning and procedural complications | Fractured Bone | Systematic Assessment | Fractured Bone |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | Pain | Systematic Assessment | Musculoskeletal Pain |
|
| Skin Burn | Skin and subcutaneous tissue disorders | Skin Burn | Systematic Assessment | Skin Burn |
|
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Colon Cancer | Systematic Assessment | Colon Cancer |
|
| Depression/Anxiety | Psychiatric disorders | Depression/Anxiety | Systematic Assessment | Depression/Anxiety |
|
| Dizziness | Ear and labyrinth disorders | Dizziness | Systematic Assessment | Dizziness |
|
| Headache | Musculoskeletal and connective tissue disorders | Headache | Systematic Assessment | Headache |
|
| Insomnia | General disorders | Insomnia | Systematic Assessment | Insomnia |
|
| Paresthesia | Nervous system disorders | Paresthesia | Systematic Assessment | Paresthesia |
|
| Renal Insufficiency | Renal and urinary disorders | Renal Insufficiency | Systematic Assessment | Renal Insufficiency |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Cough | Systematic Assessment | Cough |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Pneumonia | Systematic Assessment | Pneumonia |
|
| Hypertension | Vascular disorders | Hypertension | Systematic Assessment | Hypertension |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John F. Payne, MD | Palmetto Retina Center, LLC | (803) 931-0077 | jpayne@palmettoretina.com |
| Sep 16, 2019 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 27, 2015 | Aug 11, 2020 | ICF_001.pdf |
| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| D058449 | Intravitreal Injections |
| 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 |
| D056965 | Injections, Intraocular |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| GILA |
(60 eyes) - Monthly intravitreal injections of 0.3 mg ranibizumab for four visits combined with guided laser photocoagulation to all microaneurysms in the area of DME at visit 2 (Week 4) and then again every 3 months, if leakage is present on fluorescein angiography. If the central foveal thickness is ≤ 325 μm at visit 4 (Week 12), eyes will receive 0.3 mg ranibizumab and the extension phase will begin. For all subsequent visits in the extension phase, appropriate changes to the treatment interval with 0.3 mg ranibizumab (i.e. extend, maintain, reduce) will be made based on pre-specified SD-Optical coherence tomography criteria. If the central foveal thickness is > 325 μm at week 12, then the patient will continue to receive monthly intravitreal injections of 0.3 mg ranibizumab and possible guided laser every 3 months until the central foveal thickness is ≤ 325 μm. Once the central foveal thickness is ≤ 325 μm, then the study eye will begin the extension phase of the study. |
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| OG002 | GILA | (60 eyes) - Monthly intravitreal injections of 0.3 mg ranibizumab for four visits combined with guided laser photocoagulation to all microaneurysms in the area of DME at visit 2 (Week 4) and then again every 3 months, if leakage is present on fluorescein angiography. If the central foveal thickness is ≤ 325 μm at visit 4 (Week 12), eyes will receive 0.3 mg ranibizumab and the extension phase will begin. For all subsequent visits in the extension phase, appropriate changes to the treatment interval with 0.3 mg ranibizumab (i.e. extend, maintain, reduce) will be made based on pre-specified SD-Optical coherence tomography criteria. If the central foveal thickness is > 325 μm at week 12, then the patient will continue to receive monthly intravitreal injections of 0.3 mg ranibizumab and possible guided laser every 3 months until the central foveal thickness is ≤ 325 μm. Once the central foveal thickness is ≤ 325 μm, then the study eye will begin the extension phase of the study. |
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| OG002 | GILA | (60 eyes) - Monthly intravitreal injections of 0.3 mg ranibizumab for four visits combined with guided laser photocoagulation to all microaneurysms in the area of DME at visit 2 (Week 4) and then again every 3 months, if leakage is present on fluorescein angiography. If the central foveal thickness is ≤ 325 μm at visit 4 (Week 12), eyes will receive 0.3 mg ranibizumab and the extension phase will begin. For all subsequent visits in the extension phase, appropriate changes to the treatment interval with 0.3 mg ranibizumab (i.e. extend, maintain, reduce) will be made based on pre-specified SD-Optical coherence tomography criteria. If the central foveal thickness is > 325 μm at week 12, then the patient will continue to receive monthly intravitreal injections of 0.3 mg ranibizumab and possible guided laser every 3 months until the central foveal thickness is ≤ 325 μm. Once the central foveal thickness is ≤ 325 μm, then the study eye will begin the extension phase of the study. |
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| OG002 | GILA | (60 eyes) - Monthly intravitreal injections of 0.3 mg ranibizumab for four visits combined with guided laser photocoagulation to all microaneurysms in the area of DME at visit 2 (Week 4) and then again every 3 months, if leakage is present on fluorescein angiography. If the central foveal thickness is ≤ 325 μm at visit 4 (Week 12), eyes will receive 0.3 mg ranibizumab and the extension phase will begin. For all subsequent visits in the extension phase, appropriate changes to the treatment interval with 0.3 mg ranibizumab (i.e. extend, maintain, reduce) will be made based on pre-specified SD-Optical coherence tomography criteria. If the central foveal thickness is > 325 μm at week 12, then the patient will continue to receive monthly intravitreal injections of 0.3 mg ranibizumab and possible guided laser every 3 months until the central foveal thickness is ≤ 325 μm. Once the central foveal thickness is ≤ 325 μm, then the study eye will begin the extension phase of the study. |
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| GILA |
(60 eyes) - Monthly intravitreal injections of 0.3 mg ranibizumab for four visits combined with guided laser photocoagulation to all microaneurysms in the area of DME at visit 2 (Week 4) and then again every 3 months, if leakage is present on fluorescein angiography. If the central foveal thickness is ≤ 325 μm at visit 4 (Week 12), eyes will receive 0.3 mg ranibizumab and the extension phase will begin. For all subsequent visits in the extension phase, appropriate changes to the treatment interval with 0.3 mg ranibizumab (i.e. extend, maintain, reduce) will be made based on pre-specified SD-Optical coherence tomography criteria. If the central foveal thickness is > 325 μm at week 12, then the patient will continue to receive monthly intravitreal injections of 0.3 mg ranibizumab and possible guided laser every 3 months until the central foveal thickness is ≤ 325 μm. Once the central foveal thickness is ≤ 325 μm, then the study eye will begin the extension phase of the study. |
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| OG002 | GILA | (60 eyes) - Monthly intravitreal injections of 0.3 mg ranibizumab for four visits combined with guided laser photocoagulation to all microaneurysms in the area of DME at visit 2 (Week 4) and then again every 3 months, if leakage is present on fluorescein angiography. If the central foveal thickness is ≤ 325 μm at visit 4 (Week 12), eyes will receive 0.3 mg ranibizumab and the extension phase will begin. For all subsequent visits in the extension phase, appropriate changes to the treatment interval with 0.3 mg ranibizumab (i.e. extend, maintain, reduce) will be made based on pre-specified SD-Optical coherence tomography criteria. If the central foveal thickness is > 325 μm at week 12, then the patient will continue to receive monthly intravitreal injections of 0.3 mg ranibizumab and possible guided laser every 3 months until the central foveal thickness is ≤ 325 μm. Once the central foveal thickness is ≤ 325 μm, then the study eye will begin the extension phase of the study. |
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| OG002 | GILA | (60 eyes) - Monthly intravitreal injections of 0.3 mg ranibizumab for four visits combined with guided laser photocoagulation to all microaneurysms in the area of DME at visit 2 (Week 4) and then again every 3 months, if leakage is present on fluorescein angiography. If the central foveal thickness is ≤ 325 μm at visit 4 (Week 12), eyes will receive 0.3 mg ranibizumab and the extension phase will begin. For all subsequent visits in the extension phase, appropriate changes to the treatment interval with 0.3 mg ranibizumab (i.e. extend, maintain, reduce) will be made based on pre-specified SD-Optical coherence tomography criteria. If the central foveal thickness is > 325 μm at week 12, then the patient will continue to receive monthly intravitreal injections of 0.3 mg ranibizumab and possible guided laser every 3 months until the central foveal thickness is ≤ 325 μm. Once the central foveal thickness is ≤ 325 μm, then the study eye will begin the extension phase of the study. |
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| GILA |
(60 eyes) - Monthly intravitreal injections of 0.3 mg ranibizumab for four visits combined with guided laser photocoagulation to all microaneurysms in the area of DME at visit 2 (Week 4) and then again every 3 months, if leakage is present on fluorescein angiography. If the central foveal thickness is ≤ 325 μm at visit 4 (Week 12), eyes will receive 0.3 mg ranibizumab and the extension phase will begin. For all subsequent visits in the extension phase, appropriate changes to the treatment interval with 0.3 mg ranibizumab (i.e. extend, maintain, reduce) will be made based on pre-specified SD-Optical coherence tomography criteria. If the central foveal thickness is > 325 μm at week 12, then the patient will continue to receive monthly intravitreal injections of 0.3 mg ranibizumab and possible guided laser every 3 months until the central foveal thickness is ≤ 325 μm. Once the central foveal thickness is ≤ 325 μm, then the study eye will begin the extension phase of the study. |
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