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| Name | Class |
|---|---|
| Alimera Sciences | INDUSTRY |
| pSiVida Limited | INDUSTRY |
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Treatment of exudative age-related macular degeneration has been significantly improved by the advent of Lucentis™( which provides improved vision rather than simply stabilization) is common; however, monthly injections may be required to maintain this effect. It is hypothesized that sustained release fluocinolone acetonide will allow maintenance of the improved vision with fewer Lucentis injections.
Treatment of exudative age-related macular degeneration has been significantly improved by the advent of Lucentis™( which provides improved vision rather than simply stabilization) is common; however, monthly injections may be required to maintain this effect. The use of the glucocorticoids such as triamcinolone acetonide as adjunct treatment for exudative age-related macular degeneration has been reported to enhance the efficacy of photodynamic therapy with Visudyne® (verteporphin for injection). It is hypothesized that sustained release fluocinolone acetonide will allow maintenance of the improved vision with fewer Lucentis injections. This study is a pilot phase 2b study to test this hypothesis. The safety assessments will continue through 36 months.This study will compare the safety 2 doses of FA/Medidur in conjunction with Lucentis (as needed) in patients with neovascular AMD who have have been treated with Lucentis for at least 6 months and have reached a plateau.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Dose 0.2 ug/day Medidur implant |
|
| 2 | Active Comparator | Dose 0.5 ug/day Medidur implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluocinolone Acetonide/Medidur | Drug | 0.2 ug/day implant |
| |
| Fluocinolone Acetonide/Medidur |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Visual Acuity | Visual acuity is measured using ETDRS charts at 4 meters. | 6 mos |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Developing Cataracts | 6 mos | |
| Change in IOP From Baseline | IOP stands for intra ocular pressure | 6 mos |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter A Campochiaro, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilmer Eye Institute, Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluocinolone Acetonide: 0.2 ug/Day Implant | Dose 0.2 ug/day Medidur implant |
| FG001 | Fluocinolone Acetonide: 0.5 ug/Day Implant | Dose 0.5 ug/day Medidur implant |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluocinolone Acetonide: 0.2 ug/Day Implant | Dose 0.2 ug/day Medidur implant Fluocinolone Acetonide/Medidur : 0.2 ug/day implant |
| BG001 | Fluocinolone Acetonide: 0.5 ug/Day Implant |
| 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 From Baseline in Visual Acuity | Visual acuity is measured using ETDRS charts at 4 meters. | Posted | Mean | Standard Deviation | ETDRS letters | 6 mos |
|
|
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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 | Fluocinolone Acetonide: 0.2 ug/Day Implant | Dose 0.2 ug/day Medidur implant Fluocinolone Acetonide/Medidur : 0.2 ug/day implant |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract Operation | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA | Systematic Assessment | Study Eye |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Campochiaro, M.D. | Johns Hopkins University | pcampo@jhmi.edu |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D005446 | Fluocinolone Acetonide |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Drug |
0.5 ug/day implant |
|
Dose 0.5 ug/day Medidur implant
Fluocinolone Acetonide/Medidur : 0.5 ug/day implant
| 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 |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Number of Patients Developing Cataracts | Posted | Number | participants | 6 mos |
|
|
|
| Secondary | Change in IOP From Baseline | IOP stands for intra ocular pressure | Posted | Mean | Standard Deviation | mmHg | 6 mos |
|
|
|
| 4 |
| 4 |
| 4 |
| 4 |
| EG001 | Fluocinolone Acetonide: 0.5 ug/Day Implant | Dose 0.5 ug/day Medidur implant Fluocinolone Acetonide/Medidur : 0.5 ug/day implant | 1 | 2 | 2 | 2 |
| Cataract Operation Complication | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
|
| Cataract Subcapsular | Eye disorders | MedDRA | Systematic Assessment | Study Eye |
|
| Contrast Media Reaction | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Intraocular Pressure Increased | Investigations | MedDRA | Systematic Assessment | Study Eye |
|
| Gout | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Cataract Operation Complication | Surgical and medical procedures | MedDRA | Systematic Assessment | Study Eye |
|
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| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |