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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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The purpose of this study is to test the efficacy of an 0.7 mg intravitreal dexamethasone implant (Ozurdex®) on macular leakage and visual acuity for patients with recalcitrant diabetic macular edema.
This is an open-label, Phase II comparative study of an intravitreal dexamethasone implant versus intravitreal bevacizumab (Avastin) in 20 patients with recalcitrant diabetic macular edema and prior treatment with ≥ 2 intravitreal anti-VEGF injections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ozurdex | Active Comparator | Patients in this group receive Ozurdex at initial visit and at month 4 |
|
| Avastin | Active Comparator | Patients in this group receive Avastin Q1 month for 5 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexamethasone intravitreal implant | Drug | Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Change in Visual Acuity (Number of ETDRS Letters). | The measure the change in ETDRS letters for each treatment group from baseline to 6 months. | 6 months |
| The Change in Central Foveal Thickness (Microns on High Resolution OCT). | The measure the change in central foveal thickness for each treatment group from baseline to 6 months. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Change in Macular Leakage on Fluorescein Angiography From Baseline | To qualitatively assess the change in macular leakage on fluorescein angiography from baseline to 6 months for each treatment arm. | 6 months |
| The Change in Mean Macular Sensitivity on Microperimetry From Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ron P Gallemore, M.D, Ph.D | Retina Macula Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Macula Institute | Torrance | California | 90503 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ozurdex | Patients in this group receive Ozurdex at initial visit and at month 4 dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5) |
| FG001 | Avastin | Patients in this group receive Avastin Q1 month for 5 months. intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ozurdex | Patients in this group receive Ozurdex at initial visit and at month 4 dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5) |
| BG001 | Avastin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The Change in Visual Acuity (Number of ETDRS Letters). | The measure the change in ETDRS letters for each treatment group from baseline to 6 months. | Posted | Mean | Standard Error | ETDRS letters | 6 months |
|
6 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 | Ozurdex | Patients in this group receive Ozurdex at initial visit and at month 4 dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated Intraocular Pressure | Eye disorders | Systematic Assessment | Greater than 10 mmHg increase in intraocular pressure from baseline |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ron P. Gallemore M.D., Ph.D. | Retina Macula Institute | 310-944-9393 | rongallemoremd@gmail.com |
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| ID | Term |
|---|---|
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| intravitreal bevacizumab | Drug | Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments. |
|
|
To assess the change in macular sensitivity on microperimetry from baseline to 6 months for each treatment arm. |
| 6 months |
| The Change in Mean Central Amplitude on Multi-focal ERG From Baseline. | To assess the change in mean central amplitude on multi-focal ERG from baseline to 6 months for each treatment arm. | 6 months |
Patients in this group receive Avastin Q1 month for 5 months.
intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | The Change in Central Foveal Thickness (Microns on High Resolution OCT). | The measure the change in central foveal thickness for each treatment group from baseline to 6 months. | Posted | Mean | Standard Error | microns | 6 months |
|
|
|
| Secondary | The Change in Macular Leakage on Fluorescein Angiography From Baseline | To qualitatively assess the change in macular leakage on fluorescein angiography from baseline to 6 months for each treatment arm. | Fluorescein angiography data were not collected. | Posted | 6 months |
|
|
| Secondary | The Change in Mean Macular Sensitivity on Microperimetry From Baseline | To assess the change in macular sensitivity on microperimetry from baseline to 6 months for each treatment arm. | One patient in the Ozurdex group withdrew consent, one patient in the Avastin group was lost to follow-up, and results were unattainable for two patients due to imaging difficulties. | Posted | Mean | Standard Error | dB | 6 months |
|
|
|
| Secondary | The Change in Mean Central Amplitude on Multi-focal ERG From Baseline. | To assess the change in mean central amplitude on multi-focal ERG from baseline to 6 months for each treatment arm. | One patient in the Ozurdex group withdrew consent, one patient in the Avastin group was lost to follow-up, and results were unattainable for three other patients due to testing difficulties. | Posted | Mean | Standard Error | nV/deg2 | 6 months |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | Avastin | Patients in this group receive Avastin Q1 month for 5 months. intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments. | 0 | 10 | 0 | 10 | 0 | 10 |
|
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| 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 |
| 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 |