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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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To test the efficacy of a 0.7 mg intravitreal dexamethasone implant (Ozurdex®) on macular function and recalcitrant macular edema associated with retinal vein occlusion following treatment with 2 or more prior intravitreal anti-VEGF drug injections.
The efficacy of the DEX implant on macular edema for RVO is well established in multiple clinical trials. However, the duration and frequency of re-treatment have not been extensively explored. In addition, no prior studies have tested the efficacy of the DEX implant on retinal and macular function using diagnostic testing measurements such as multi-focal ERG, microperimetry and RAM testing. Since VA and OCT outcomes do not always correlate, these other assessments (mf-ERG, microperimetry, RAM testing) may be useful as early predictors of when or if patients should be retreated. This study will assess 2 groups (0.7mg PRN and 0.7mg Q16 weeks) and assess high resolution OCT, RAM testing, microperimetry, and Multi-focal ERG outcomes. For the PRN group retreated based on any fluid on OCT, we will investigate if microperimetry or multifocal ERG changes would have been an earlier predictor of fluid returning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ozurdex PRN | Active Comparator | 0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT |
|
| Ozurdex Q16 weeks | Active Comparator | 0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozurdex | Drug | 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Macular Function Using Microperimetry | To determine if there is change in mean macular sensitivity using microperimetry at 48 weeks compared to baseline for both the PRN and Q16weeks treatment groups | baseline to 48 weeks |
| Macular Function Using Multi-focal ERG | To determine if there is a change in central amplitude responses using multifocal ERG at 48 weeks compared to baseline values for both the PRN and Q16weeks treatment groups | baseline to 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To Determine if There is a Change in Visual Acuity (Number of ETDRS Letters) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups | baseline to 48 weeks | |
| To Determine if There is a Change in Central Foveal Thickness (Microns on High Resolution OCT) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups |
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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 |
| Behnam Sharareh, B.S | Retina Macula Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Macula Institute | Torrance | California | 90503 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Comparator: Ozurdex PRN | Drug: dexamethasone intravitreal implant Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and PRN every 16 weeks Other Name: Ozurdex PRN |
| FG001 | Active Comparator: Ozurdex q16 Weeks | Drug: dexamethasone intravitreal implant Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and every 16 weeks Other Name: Ozurdex q16 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ozurdex PRN | Drug: dexamethasone intravitreal implant Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and PRN every 16 weeks Other Name: Ozurdex PRN |
| BG001 | Ozurdex q16 Weeks |
| 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 | Macular Function Using Microperimetry | To determine if there is change in mean macular sensitivity using microperimetry at 48 weeks compared to baseline for both the PRN and Q16weeks treatment groups | Posted | Mean | Standard Error | dB | baseline to 48 weeks |
|
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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 PRN | 0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT Ozurdex: 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract Requiring Emergent Surgery | Eye disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated Intraocular Pressure | Eye disorders | Systematic Assessment | Greater than 10 mmHg above baseline measure |
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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 |
|---|---|
| D012170 | Retinal Vein Occlusion |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
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| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Ozurdex | Drug | 0.7 mg intravitreal DEX implant on first visit then every 16 weeks |
|
|
| baseline to 48 weeks |
Drug: dexamethasone intravitreal implant Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and every 16 weeks
Other Name: Ozurdex PRN
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Macular Function Using Multi-focal ERG | To determine if there is a change in central amplitude responses using multifocal ERG at 48 weeks compared to baseline values for both the PRN and Q16weeks treatment groups | Posted | Mean | Standard Error | nV/deg2 | baseline to 48 weeks |
|
|
|
| Secondary | To Determine if There is a Change in Visual Acuity (Number of ETDRS Letters) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups | Posted | Mean | Standard Error | ETDRS letters | baseline to 48 weeks |
|
|
|
| Secondary | To Determine if There is a Change in Central Foveal Thickness (Microns on High Resolution OCT) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups | Posted | Mean | Standard Error | microns | baseline to 48 weeks |
|
|
|
| 0 |
| 5 |
| 1 |
| 5 |
| 0 |
| 5 |
| EG001 | Ozurdex Q16 Weeks | 0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks Ozurdex: 0.7 mg intravitreal DEX implant on first visit then every 16 weeks | 1 | 5 | 0 | 5 | 1 | 5 |
|
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| D016769 |
| Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| 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 |