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Visual outcomes using monthly ranibizumab therapy are well established in clinical trials, but the best way to assess when and how to treat patients with PRN therapy has not been proven. Information is lacking on Multi-focal ERG and microperimetry outcomes with ranibizumab therapy. Additionally, VA and OCT outcomes don't always correlate and other assessments such as the Multi-focal ERG and microperimetry may be useful as early predictors of when patients should be retreated. This study will assess 2 groups (monthly and PRN therapy) and assess high resolution OCT, microperimetry, and Multi-focal ERG outcomes. For the PRN group retreatment will be based on OCT criteria. We will investigate if microperimetry or multifocal ERG would have been an early predictor of fluid recurrence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monthly | Active Comparator | Ranibizumab injections every month for 12 months. |
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| As Needed | Active Comparator | Ranibizumab injections monthly for 4 months then as needed thereafter. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCT, Multifocal ERG, Microperimetry | Device | OCT performed monthly. Fluorescein Angiography performed at baseline, month 3, month 5, month 8 and month 12. Microperimetry performed at baseline, month 3, month 5, month 8, and month 12 for monthly ranibizumab and at baseline, month 3, month 5 through month 12 for as needed ranibizumab. Multifocal ERG done at the same monthly visits as the microperimetry. |
| Measure | Description | Time Frame |
|---|---|---|
| Multifocal Electroretinography N1-P1 Amplitude | As measured within the central ring of the multifocal electroretinography study this measurement is the difference between the first positive peak (P1) and the first negative peak (N1). | One Year |
| Microperimetry Mean Sensitivity | One Year |
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity | One Year | |
| Central Foveal Thickness on Optical Coherence Tomography | One Year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ron P. Gallemore, MD, PhD | 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 | Monthly Ranibizumab 0.5 mg | Intravitreal ranibizumab 0.5 mg dosing monthly for entire study. |
| FG001 | PRN Ranibizumab 0.5 mg | Intravitreal ranibizumab 0.5 mg dosing monthly for initial 4 injections followed by as needed dosing based on the presence of fluid on optical coherence tomography imaging. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Ranibizumab Ophthalmic | Drug | 0.5 mg ranibizumab vs 2.0 mg ranibizumab |
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| FG002 | Monthly Ranibizumab 2.0 mg | Intravitreal ranibizumab 2.0 mg dosing monthly for entire study. |
| FG003 | PRN Ranibizumab 2.0 mg | Intravitreal ranibizumab 2.0 mg dosing monthly for initial 4 injections followed by as needed dosing based on the presence of fluid on optical coherence tomography imaging. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Monthly Ranibizumab 0.5 mg | Intravitreal ranibizumab 0.5 mg dosing monthly for entire study. |
| BG001 | PRN Ranibizumab 0.5 mg | Intravitreal ranibizumab 0.5 mg dosing monthly for initial 4 injections followed by as needed dosing based on the presence of fluid on optical coherence tomography imaging. |
| BG002 | Monthly Ranibizumab 2.0 mg | Intravitreal ranibizumab 2.0 mg dosing monthly for entire study. |
| BG003 | PRN Ranibizumab 2.0 mg | Intravitreal ranibizumab 2.0 mg dosing monthly for initial 4 injections followed by as needed dosing based on the presence of fluid on optical coherence tomography imaging. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | 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 | Multifocal Electroretinography N1-P1 Amplitude | As measured within the central ring of the multifocal electroretinography study this measurement is the difference between the first positive peak (P1) and the first negative peak (N1). | Required maintenance on device limited data collection for part of the study population. | Posted | Mean | Standard Error | nV/deg^2 | One Year |
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| Primary | Microperimetry Mean Sensitivity | For 4 patients, data was unavailable on microperimetry from all visits (including screening). | Posted | Mean | Standard Error | dB | One Year |
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| Secondary | Best Corrected Visual Acuity | Posted | Mean | Standard Error | Letters | One Year |
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| Secondary | Central Foveal Thickness on Optical Coherence Tomography | Posted | Mean | Standard Error | micrometers | One 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 | Monthly Ranibizumab 0.5 mg | Intravitreal ranibizumab 0.5 mg dosing monthly for entire study. | 0 | 22 | 1 | 22 | ||
| EG001 | PRN Ranibizumab 0.5 mg | Intravitreal ranibizumab 0.5 mg dosing monthly for initial 4 injections followed by as needed dosing based on the presence of fluid on optical coherence tomography imaging. | 2 | 25 | 2 | 25 | ||
| EG002 | Monthly Ranibizumab 2.0 mg | Intravitreal ranibizumab 2.0 mg dosing monthly for entire study. | 0 | 12 | 0 | 12 | ||
| EG003 | PRN Ranibizumab 2.0 mg | Intravitreal ranibizumab 2.0 mg dosing monthly for initial 4 injections followed by as needed dosing based on the presence of fluid on optical coherence tomography imaging. | 0 | 18 | 0 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Uveitic Glaucoma | Eye disorders |
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| Vitreous Hemorrhage | Eye disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal Abrasion | Eye disorders |
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| Injection Site Irritation | Eye disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ron Gallemore | Retina Macula Institute | rongallemoremd@gmail.com |
| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |
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| Male |
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| 1-year |
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