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| ID | Type | Description | Link |
|---|---|---|---|
| 100,481 | Other Identifier | FDA IND |
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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
| Genentech, Inc. | INDUSTRY |
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Because a possible synergism of radiation and inhibitors of vascular endothelial growth factor has been shown in cancer patients and patients with wet macular degeneration, this pilot study is being conducted to determine whether treating wet macular degeneration with a combination of Lucentis and proton beam irradiation is safe. Lucentis is an inhibitor of vascular endothelial growth factor which was recently FDA approved for treatment of wet macular degeneration. It appears to be the most effective therapy thus far for wet macular degeneration among all drugs FDA approved for this condition. If no major safety issues are associated with this combination therapy, a larger study will be conducted to determine whether this combination therapy is more effective than Lucentis monotherapy.
Five subjects diagnosed with wet macular degeneration will be treated with standard of care, i.e. intravitreal Lucentis injection monthly for the first four months and as needed thereafter. Within six weeks of the first Lucentis injection, the eye will also be treated with 24 Gy of proton beam divided into two fractions. Each subject will be followed for 2 yrs with monthly examination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| proton beam with ranibizumab | Experimental | Intervention is 24Gy proton radiation in 2 fractions given within 6 weeks of first dose of intravitreal ranibizumab (0.5mg) drug combined with four monthly doses of intravitreal lucentis and monthly prn lucentis thereafter. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton beam irradiation and ranibizumab | Drug | ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Ocular Adverse Events | Any ocular adverse event identified by eye examination during the study follow-up will be recorded and determined for possible or probable relation to study treatment. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 1. Change in BCVA From Baseline | change in number of letter read correctly in study eye compared to the number of letters read correctly at baseline, i.e. BCVA (number of letters read correctly) at 24 months minus BCVA (number of letters read correctly) at baseline | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susanna S Park, MD PhD | University of California, Davis | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22183743 | Result | Park SS, Daftari I, Phillips T, Morse LS. Three-year follow-up of a pilot study of ranibizumab combined with proton beam irradiation as treatment for exudative age-related macular degeneration. Retina. 2012 May;32(5):956-66. doi: 10.1097/IAE.0b013e31822a8d6a. |
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Findings have been presented at national and international venues and published in scientific peer-reviewed journal
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| ID | Title | Description |
|---|---|---|
| FG000 | Lucentis Combined With Proton Beam | Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lucentis Combined With Proton Beam | Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study. |
| 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 | Incidence and Severity of Ocular Adverse Events | Any ocular adverse event identified by eye examination during the study follow-up will be recorded and determined for possible or probable relation to study treatment. | Posted | Number | number of adverse events | 24 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 | Lucentis Combined With Proton Beam | Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susanna Park MD PhD | University of California Davis | 916-734-6074 | sscpark@ucdavis.edu |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D057135 | Wet Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Best corrected visual acuity | Number of letters read correctly | Mean | Standard Deviation | logMAR best corrected visual acuity |
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| Optical coherence tomography central macular thickness | Central macular thickness for quantitative measure; qualitative measure of presence or absence of intraretinal or subretinal fluid | Mean | Standard Deviation | microns |
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| Secondary | 1. Change in BCVA From Baseline | change in number of letter read correctly in study eye compared to the number of letters read correctly at baseline, i.e. BCVA (number of letters read correctly) at 24 months minus BCVA (number of letters read correctly) at baseline | Posted | Mean | Standard Deviation | change in number of letters | 24 months |
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| 0 |
| 6 |
| 0 |
| 6 |
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |