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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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In this pilot study the researchers will evaluate the safety and efficacy of 50% reduced fluence PDT combination therapy with ranibizumab. The researchers hope to gain information regarding the use of reduced fluence PDT combination therapy. The information gained from this pilot study may prompt further definitive studies comparing the safety and efficacy of both standard fluence PDT combination therapy, reduced fluence PDT combination therapy, and ranibizumab monotherapy.
The study will compare the use of combination therapy with ranibizumab and verteporfin PDT to ranibizumab alone in patients with exudative age-related macular degeneration (AMD). All patients will receive three consecutive monthly treatments with ranibizumab. Patients will be randomized 1:1:1 to 3 groups. Patients randomized to group 1 will receive only ranibizumab. Patients randomized to group 2 will also receive one treatment with reduced fluence (50% fluence) verteporfin PDT at day 0. Patients randomized to group 3 will also receive one treatment with standard fluence verteporfin PDT. All patients will also be evaluated for possible retreatment with ranibizumab and verteporfin PDT according to established criteria. Thirty patients will be recruited from one U.S. sites. Randomization will occur at the time of entry into the study. Follow-up will continue until month 12 (from day 0) in all subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Standard Fluence Photodynamic Therapy combined with ranibizumab |
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| 2 | Experimental | Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab |
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| 3 | Active Comparator | Ranibizumab monotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | intravitreal administered ranibizumab 0.5 mg in 0.05 mL |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in BCVA of ETDRS Letters From Baseline at 12 Months | Visual acuity is often measured using a chart called the ETDRS chart (Early Treatment Diabetic Retinopathy Study). A letter score is calculated based on the number of letters that can be correctly identified from specified distances. Higher letter scores correspond to better visual acuity. Lower letter scores mean poorer visual acuity. In this study the baseline visual acuity in letters is subtracted from the visual acuity in letters measured at the 12 month visit providing a letter score of vision gain or vision loss. | 12 months |
| Mean Letters Gained of Best Corrected Visual Acuity Using ETDRS Protocol | Visual acuity is often measured using a chart called the ETDRS chart (Early Treatment Diabetic Retinopathy Study). A letter score is calculated based on the number of letters that can be correctly identified from specified distances. Higher letter scores correspond to better visual acuity. Lower letter scores mean poorer visual acuity. In this study the baseline visual acuity in letters is subtracted from the visual acuity in letters measured at the 12 month visit providing a letter score of vision gain or vision loss. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Retreatment After Loading Doses | 12 months | |
| Average Number of PDT Retreatments Over 12 Months | 12 months | |
| Central Macular Thickness Reduction on OCT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott J Westhouse, DO | Oklahoma State University Medical Center | Principal Investigator |
| Raymond Townsend, MD | Oklahoma State University Medical Center | Principal Investigator |
| John Saurino, DO | Oklahoma State University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eagle Mountain Vision | Tulsa | Oklahoma | 74132 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Fluence PDT | Standard Fluence Photodynamic Therapy combined with ranibizumab |
| FG001 | 50% Fluence PDT | Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Verteporfin | Drug | Verteporfin with 50% fluence photodynamic therapy (25 J/cm2) |
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| Verteporfin | Drug | Verteporfin with standard fluence photodynamic therapy (50 J/cm2) |
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| 12 months |
| Average Number of Ranibizumab Retreatments Over 12 Months | 12 months |
| FG002 | Ranibizumab | Ranibizumab monotherapy |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Fluence PDT | Standard Fluence Photodynamic Therapy combined with ranibizumab |
| BG001 | 50% Fluence PDT | Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab |
| BG002 | Ranibizumab | Ranibizumab monotherapy |
| BG003 | 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | Mean Change in BCVA of ETDRS Letters From Baseline at 12 Months | Visual acuity is often measured using a chart called the ETDRS chart (Early Treatment Diabetic Retinopathy Study). A letter score is calculated based on the number of letters that can be correctly identified from specified distances. Higher letter scores correspond to better visual acuity. Lower letter scores mean poorer visual acuity. In this study the baseline visual acuity in letters is subtracted from the visual acuity in letters measured at the 12 month visit providing a letter score of vision gain or vision loss. | Posted | Mean | 95% Confidence Interval | Letters | 12 months |
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| Primary | Mean Letters Gained of Best Corrected Visual Acuity Using ETDRS Protocol | Visual acuity is often measured using a chart called the ETDRS chart (Early Treatment Diabetic Retinopathy Study). A letter score is calculated based on the number of letters that can be correctly identified from specified distances. Higher letter scores correspond to better visual acuity. Lower letter scores mean poorer visual acuity. In this study the baseline visual acuity in letters is subtracted from the visual acuity in letters measured at the 12 month visit providing a letter score of vision gain or vision loss. | Posted | Mean | Standard Deviation | letters | 12 months |
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| Secondary | Time to First Retreatment After Loading Doses | Posted | Mean | Standard Deviation | Month | 12 months |
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| Secondary | Average Number of PDT Retreatments Over 12 Months | Posted | Mean | Standard Deviation | Number of Treatments | 12 months |
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| Secondary | Central Macular Thickness Reduction on OCT | Posted | Mean | Standard Deviation | micron (um) | 12 months |
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| Secondary | Average Number of Ranibizumab Retreatments Over 12 Months | Posted | Mean | Standard Deviation | Number of Treatments | 12 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 | Standard Fluence PDT | Standard Fluence Photodynamic Therapy combined with ranibizumab | 0 | 10 | 0 | 10 | ||
| EG001 | 50% Fluence PDT | Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab | 0 | 11 | 0 | 11 | ||
| EG002 | Ranibizumab | Ranibizumab monotherapy | 2 | 10 | 0 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | Non-systematic Assessment | greater than 2 months after last ranibizumab |
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| cardiopulmonary arrest | Cardiac disorders | Non-systematic Assessment | following hip fracture and complications greater than 2 months after ranibizumab |
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This study was limited by a small number of subjects. Additionally, several subjects did not meet the 12 month study endpoint. These subjects were included in the final analysis if their last visit was within 2 months of the final endpoint.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Westhouse, DO | Retina Specialists of Michigan | 616-954-2020 | s.westhouse@gmail.com |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| D000077362 | Verteporfin |
| ID | Term |
|---|---|
| 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 |
| D011166 | Porphyrins |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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