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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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To determine if there is visual benefit with Ozurdex treatment every three months compared to monthly anti-VEGF alone, in subjects with persistent diabetic macular edema. The investigator hypothesizes more frequent administration of Ozurdex in patients that have persistent diabetic macular edema will result in a more rapid and sustained improvement of visual acuity and/or optical coherence topography (OCT) compared to the use of anti-VEGF alone.
Statistics throughout this study referred to the number of eyes rather than the number of subjects. Subjects were allowed to have both eyes in the study provided that inclusion/exclusion criteria were met. Five subjects had both eyes in the study; 45 subjects were actually enrolled, resulting in 50 study eyes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab | Active Comparator | 1.25 mg intravitreal injection given monthly during a 6 month period |
|
| Ozurdex | Active Comparator | Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozurdex | Drug | intravitreal steroid |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Visual Acuity Change | Visual acuity was obtained using ETDRS method and the total number of letters correct using that method was used to calculate mean visual acuity change. | baseline to month 7 |
| Change in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) From Baseline to Month Seven | Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture micrometer-resolution, three-dimensional images. The image is presented in grid form which divides that retina into sections. The center most section (CST) is used for this outcome measurement. | baseline to month seven |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raj K Maturi, MD | Raj K. Maturi, MD, PC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Raj K Maturi MD PC | Indianapolis | Indiana | 46290 | United States |
This trial had 50 study eyes from a total of 45 participants. 5 participants had both eyes in the study.
Subjects were recruited from the PI's clinical practice from January 2014 through October 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab | 1.25 mg intravitreal injection given monthly during a 6 month period Bevacizumab: antiVEGF |
| FG001 | Ozurdex | Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections Ozurdex: intravitreal steroid |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Bevacizumab | Drug | antiVEGF |
|
|
| COMPLETED |
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| NOT COMPLETED |
|
23 and 27 reflect number of study eyes in each arm rather than number of subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab | 1.25 mg intravitreal injection given monthly during a 6 month period Bevacizumab: antiVEGF |
| BG001 | Ozurdex | Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections Ozurdex: intravitreal steroid |
| 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 |
| ||||||||||||||||||
| Region of Enrollment | Number | study 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 Visual Acuity Change | Visual acuity was obtained using ETDRS method and the total number of letters correct using that method was used to calculate mean visual acuity change. | Posted | Mean | Standard Deviation | ETDRS letters | baseline to month 7 | eyes | Participants |
|
|
| |||||||||||||||||||||||||||||
| Primary | Change in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) From Baseline to Month Seven | Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture micrometer-resolution, three-dimensional images. The image is presented in grid form which divides that retina into sections. The center most section (CST) is used for this outcome measurement. | Posted | Mean | Standard Deviation | microns | baseline to month seven | study eyes | Participants |
|
|
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Data entered is based on number of study eyes rather than number of participants. Systemic serious adverse events are reported based on the number of participants (45), ophthalmic AEs are based on number of study eyes (50)
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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 | Bevacizumab | 1.25 mg intravitreal injection given monthly during a 6 month period Bevacizumab: antiVEGF | 7 | 23 | 10 | 23 | ||
| EG001 | Ozurdex | Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections Ozurdex: intravitreal steroid | 3 | 22 | 15 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vitreous hemorrhage | Eye disorders |
| |||
| cranial nerve VI palsy | Eye disorders |
| |||
| choroidal detachment | Eye disorders |
| |||
| bradycardia | Cardiac disorders |
| |||
| pneumonia | Respiratory, thoracic and mediastinal disorders |
| |||
| pyelonephritis | Renal and urinary disorders |
| |||
| colon cancer | Gastrointestinal disorders |
| |||
| congestive heart failure | Cardiac disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| epiretinal membrane | Eye disorders |
| |||
| vitreous syneresis | Eye disorders |
| |||
| posterior capsule opacification | Eye disorders |
| |||
| vitreous hemorrhage | Eye disorders |
| |||
| worsening of cataract | Eye disorders |
| |||
| increased intraocular pressure | Eye disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raj K. Maturi, MD | Raj K. Maturi, MD, PC | 317-817-1414 | rmaturi@gmail.com |
| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| D003907 | Dexamethasone |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| 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 |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| 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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| >=65 years |
|
| Male |
|
| study eyes |
|
|