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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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This study is to see whether treating diabetic retinal swelling with ranibizumab injections into the eye monthly is better than treating diabetic retinal swelling with ranibizumab injections into the eye less frequently.
This is a prospective randomized study comparing two groups of patients with diabetic macular edema. One group will receive injections of ranibizumab monthly and the other group will have the option to receive injections of ranibizumab less frequently. That is eligible to receive the injections less frequently will have fewer injections given if the patients in that group are doing well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monthly Ranibizumab | Active Comparator | Patients randomized to the Monthly Ranibizumab arm of the study will be administered intravitreal injections each month for their diabetic macular edema for the duration of the study. |
|
| Treat and Extend Ranibizumab | Experimental | Patients randomized to this arm of the study will receive intravitreal injections of ranibizumab until their maculae are anatomically "dry," at which point the evaluation and injection interval will be extended. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | Pars plana injection of ranibizumab 0.5mg into the vitreous cavity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Early Treatment for Diabetic Retinopathy Study (ETDRS) Eye Chart Vision. | The ETDRS eye chart was used to assess vision at each visit, with the change through month 24 reported. | Baseline through 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Injections. | The average number of intravitreal ranibizumab injections in each arm of the study will be recorded. | 24 months |
| Mean Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Central Foveal Thickness (CFT). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Eichenbaum, MD | Retina Vitreous Associates of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Vitreous Associates of Florida | Clearwater | Florida | 33756 | United States | ||
| Retina Vitreous Associates of Florida |
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| ID | Title | Description |
|---|---|---|
| FG000 | Monthly Ranibizumab | Patients randomized to the Monthly Ranibizumab arm of the study will be administered intravitreal injections each month for their diabetic macular edema for the duration of the study. Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity. |
| FG001 | Treat and Extend Ranibizumab | Patients randomized to this arm of the study will receive intravitreal injections of ranibizumab until their maculae are anatomically "dry," at which point the evaluation and injection interval will be extended. Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Monthly Ranibizumab | Patients randomized to the Monthly Ranibizumab arm of the study will be administered intravitreal injections each month for their diabetic macular edema for the duration of the study. Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity. |
| BG001 |
| 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 |
| 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 Early Treatment for Diabetic Retinopathy Study (ETDRS) Eye Chart Vision. | The ETDRS eye chart was used to assess vision at each visit, with the change through month 24 reported. | Posted | Mean | Standard Deviation | ETDRS Letters | Baseline through 24 months |
|
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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 Ranibizumab | Patients randomized to the Monthly Ranibizumab arm of the study will be administered intravitreal injections each month for their diabetic macular edema for the duration of the study. Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Death | Systematic Assessment | Suspected MI |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vitreous Hemorrhage | Eye disorders | Non-systematic Assessment |
Small sample size, single-center, unmasked trial. This pilot study should be interpreted in the context of these limitations, yet may yield some guidance on one of the more common dosing methods for anti-VEGF medications in DME.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Eichenbaum, MD | Retina Vitreous Associates of Florida | 727-323-0077 | deichenbaum@retinavitreous.com |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Ranibizumab | Drug | Pars plana injection of ranibizumab 0.5mg into the vitreous cavity. |
|
|
Evaluate the average change in the swelling from diabetic macular edema measured with the optical coherence tomography machine.
| 24 months |
| Percentage of Patients With Best Corrected Visual Acuity (BCVA) Snellen-equivalent of 20/40 or Better. | The percentage of patients with 20/40 vision as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 20 feet. | 24 months |
| Percentage of Patients Anatomically "Dry." | Spectral domain OCT will be used to check the patients' central foveal thickness at each visit and the percentage with "dry" maculas at months 3,6, and 12 based on spectral domain OCT measurements per the study protocol will be recorded. | 24 Months |
| St. Petersburg |
| Florida |
| 33711 |
| United States |
| Treat and Extend Ranibizumab |
Patients randomized to this arm of the study will receive intravitreal injections of ranibizumab until their maculae are anatomically "dry," at which point the evaluation and injection interval will be extended. Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | 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 |
|
|
|
| Secondary | Mean Number of Injections. | The average number of intravitreal ranibizumab injections in each arm of the study will be recorded. | Posted | Mean | Standard Deviation | injections | 24 months |
|
|
|
| Secondary | Mean Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Central Foveal Thickness (CFT). | Evaluate the average change in the swelling from diabetic macular edema measured with the optical coherence tomography machine. | Posted | Mean | Standard Deviation | microns | 24 months |
|
|
|
| Secondary | Percentage of Patients With Best Corrected Visual Acuity (BCVA) Snellen-equivalent of 20/40 or Better. | The percentage of patients with 20/40 vision as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 20 feet. | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Secondary | Percentage of Patients Anatomically "Dry." | Spectral domain OCT will be used to check the patients' central foveal thickness at each visit and the percentage with "dry" maculas at months 3,6, and 12 based on spectral domain OCT measurements per the study protocol will be recorded. | Posted | Count of Participants | Participants | 24 Months |
|
|
|
| 1 |
| 10 |
| 3 |
| 10 |
| 0 |
| 10 |
| EG001 | Treat and Extend Ranibizumab | Patients randomized to this arm of the study will receive intravitreal injections of ranibizumab until their maculae are anatomically "dry," at which point the evaluation and injection interval will be extended. Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity. | 0 | 10 | 1 | 10 | 1 | 10 |
| Renal Failure | Renal and urinary disorders | Non-systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
|
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| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |