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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
| Doheny Image Reading Center | OTHER |
| The Retina Partners | OTHER |
This is an open-label, Phase I/II study of intravitreally administered 0.3mg ranibizumab in subjects with diabetic macular edema and lipid exudates in the central subfield.
This is an open-label, Phase I/II study of intravitreally administered 0.3mg ranibizumab in subjects with diabetic macular edema and lipid exudates in the central subfield.
Consented, enrolled subjects will receive multiple open-label intravitreal injections on 0.3mg ranibizumab administered every 30 days for 12 months per the treatment algorithm.
The patients will be randomized to 1 of 2 treatment groups. Group 1: Treatment algorithm based on the Diabetic Retinopathy Clinical Research (DRCR) protocol I 4:2:7 strategy based on the presence of macular edema.
Group 2: Continue treatment until not only the macular edema is resolved but also until the lipid exudate is resolved.
Sample size: 30 eyes Follow-up Schedule: Every 4 weeks throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetic macular edema treatment group (Group 1) | Active Comparator | Treatment using intravitreal ranibizumab 0.3mg based on the DRCR protocol I 4:2:7 strategy based on the presence of macular edema. |
|
| Diabetic macular edema and lipid treatment group (Group 2) | Active Comparator | Continued treatment with intravitreal ranibizumab 0.3mg until, not only the macular edema is resolved, but also until the lipid exudate is resolved. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranibizumab 0.3mg | Drug | intravitreally administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity as Measured by ETDRS at 6 and 12 Months | Compare Group 1 and Group 2 for best correct visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters. | 6-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Eyes With Improvement of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography | 12 months | |
| Percentage of Eyes With Complete Resolution of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography |
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Subjects will be eligible if the following criteria are met:
Inclusion Criteria
Exclusion Criteria
Subjects who meet any of the following criteria will be excluded from this study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Coast Retina Center; Carson, McBeath, Boswell, Inc | Huntington Beach | California | 92647 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Diabetic Macular Edema Treatment Group (Group 1) | Treatment using intravitreal ranibizumab 0.3mg based on the DRCR protocol I 4:2:7 strategy based on the presence of macular edema. ranibizumab 0.3mg: intravitreally administered |
| FG001 | Diabetic Macular Edema and Lipid Treatment Group (Group 2) |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2014 |
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|
| 12 months |
| Number of Eyes With Complete Resolution in the Central Subfield as Measured on OCT and Fundus Photography | 12 months |
| Percentage of Eyes With Improvement in Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography | 12 months |
| Percentage of Patients With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured on OCT and Fundus Photography | 12 months |
| Number of Eyes With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography | 12 months |
| Incidence and Severity of Ocular Adverse Events as a Measure of Safety and Tolerability | 12 months |
| Incidence and Severity of Other Adverse Events as a Measure of Safety and Tolerability | 12 months |
| South Coast Retina Center; Carson, McBeath, and Boswell, Inc |
| Long Beach |
| California |
| 90505 |
| United States |
| Retina Partners | Santa Monica | California | 90404 | United States |
| South Coast Retina Center; Carson, McBeath, Boswell, Inc | Torrance | California | 90505 | United States |
Continued treatment with intravitreal ranibizumab 0.3mg until, not only the macular edema is resolved, but also until the lipid exudate is resolved. ranibizumab 0.3mg: intravitreally administered |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Diabetic Macular Edema Treatment Group (Group 1) | Treatment using intravitreal ranibizumab 0.3mg based on the DRCR protocol I 4:2:7 strategy based on the presence of macular edema. ranibizumab 0.3mg: intravitreally administered |
| BG001 | Diabetic Macular Edema and Lipid Treatment Group (Group 2) | Continued treatment with intravitreal ranibizumab 0.3mg until, not only the macular edema is resolved, but also until the lipid exudate is resolved. ranibizumab 0.3mg: intravitreally administered |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Best Corrected Visual Acuity as Measured by ETDRS at 6 and 12 Months | Compare Group 1 and Group 2 for best correct visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters. | Posted | Mean | Standard Deviation | letters read correctly | 6-12 months | Eyes | Eyes |
|
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| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Eyes With Improvement of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography | Posted | Number | percentage of eyes | 12 months | eyes | eyes |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Eyes With Complete Resolution of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography | Posted | Number | percentage of eyes | 12 months | eyes | eyes |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Eyes With Complete Resolution in the Central Subfield as Measured on OCT and Fundus Photography | Posted | Number | eyes | 12 months | eyes | eyes |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Eyes With Improvement in Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography | Posted | Number | percentage of eyes | 12 months | eyes | eyes |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured on OCT and Fundus Photography | Posted | Number | participants | 12 months |
|
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Eyes With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography | Posted | Number | eyes | 12 months | eyes | eyes |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence and Severity of Ocular Adverse Events as a Measure of Safety and Tolerability | eyes | Posted | Count of Participants | Participants | 12 months |
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| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence and Severity of Other Adverse Events as a Measure of Safety and Tolerability | eyes | Posted | Count of Participants | Participants | 12 months |
|
|
1 year
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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 | Diabetic Macular Edema Treatment Group (Group 1) | Treatment using intravitreal ranibizumab 0.3mg based on the DRCR protocol I 4:2:7 strategy based on the presence of macular edema. ranibizumab 0.3mg: intravitreally administered | 0 | 12 | 3 | 12 | 9 | 12 |
| EG001 | Diabetic Macular Edema and Lipid Treatment Group (Group 2) | Continued treatment with intravitreal ranibizumab 0.3mg until, not only the macular edema is resolved, but also until the lipid exudate is resolved. ranibizumab 0.3mg: intravitreally administered | 0 | 12 | 2 | 12 | 9 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cysticercosis | Gastrointestinal disorders | Non-systematic Assessment | Tapeworm - recovered with sequelae |
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| Low Hemoglobin | Cardiac disorders | Non-systematic Assessment | low hemoglobin due to congestive heart failure |
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| Congestive Heart Failure | Cardiac disorders | Non-systematic Assessment |
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| Kidney Infection | Infections and infestations | Non-systematic Assessment |
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| Stroke | Vascular disorders | Non-systematic Assessment |
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| Appendix Surgery | Infections and infestations | Non-systematic Assessment |
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| Heart Attack | Cardiac disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear Infection | Ear and labyrinth disorders | Non-systematic Assessment |
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| Elevated Blood Pressure | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Influenza | Infections and infestations | Non-systematic Assessment |
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| Decreased Liver Function | Renal and urinary disorders | Non-systematic Assessment |
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| Branch Retinal Artery Occlusion | Eye disorders | Systematic Assessment |
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| Headache | Vascular disorders | Non-systematic Assessment |
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| Shingles | Immune system disorders | Non-systematic Assessment |
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| Elevated Triglycerides | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Central Retinal Vein Occlusion | Eye disorders | Systematic Assessment |
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| Sinusitis | Infections and infestations | Non-systematic Assessment |
| ||
| Ear Infection | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Ocular Hypertension | Eye disorders | Non-systematic Assessment |
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| Broken Wrist | Social circumstances | Non-systematic Assessment |
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| Allergic conjunctivitis | Eye disorders | Systematic Assessment |
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| Right Hip Injury | Social circumstances | Non-systematic Assessment |
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| Drug Administration Error | Product Issues | Systematic Assessment | Incorrect drug administered |
| |
| Subconjunctival Hemhorrage | Eye disorders | Systematic Assessment |
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| Visual Acuity Loss | Eye disorders | Systematic Assessment |
| ||
| Metastatic Tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Floater | Eye disorders | Systematic Assessment |
| ||
| Nausea/Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Julie Gasperini | South Coast Retina Center | 5629847024 | jgasperini@gmail.com |
| Dec 11, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| 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 |
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| Between 18 and 65 years |
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| >=65 years |
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| eyes |
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| eyes |
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| eyes |
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| eyes |
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