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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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The purpose of the study is to investigate whether the efficacy of Lucentis treatment for exudative age-related macular degeneration is associated with VEGF and HTRA1 DNA polymorphisms
Age-related macular degeneration (AMD) is a progressive disease that causes irreversible visual impairment and blindness in nearly 50 million people globally. Although geographic atrophy and neovascularization represent the advanced forms of AMD, neovascular AMD is the more aggressive form and accounts for almost 90% of blindness from this disease. It is characterized by choroidal neovascularization (CNV) which is the development of abnormal blood vessels underneath the retina. Randomized clinical trials (MARINA, ANCHOR) have conclusively demonstrated that continued intravitreal therapy with Lucentis (ranibizumab) in patients with subfoveal CNV from AMD leads to stabilization of vision in over 90% of patients and improvement in vision in at least a third of the patients and has led to the approval of Lucentis for the treatment of neovascular AMD (see investigator brochure). This study could provide insight as to the reasons that some patients do not experience vision stabilization with Lucentis, and could possibly help physicians to determine which patients are the best candidates for receiving Lucentis.
This is an open-label study of 100 treatment-naïve (study eye only) AMD patients treated on-label with intravitreally administered Lucentis. Consented, enrolled subjects will receive multiple open-label intravitreal injections of 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months. Their blood will be genotyped and sequenced for various SNPs on VEGF and HTRA1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lucentis | Experimental | Consented, enrolled subjects will receive multiple open-label intravitreally administered 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | Intravitreal injections of 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Determine the Genotype at VEGF and HTRA1 SNPs of Patients Gaining ≥ 0 Letters of Visual Acuity in Response to Ranibizumab Treatment Over a 4 Month Period. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| To Determine the Genotype at VEGF and HTRA1 SNPs of Patients Who Lose Visual Acuity (Gain <0 Letters) at 4, 6 and 12 Months After Initial Treatment. | 5 years | |
| To Determine Whether Change in Retinal Thickness is Correlated With Genotype | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shiley Eye Center, University of California, San Diego | San Diego | California | 92093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23745581 | Derived | Zhao L, Grob S, Avery R, Kimura A, Pieramici D, Lee J, Rabena M, Ortiz S, Quach J, Cao G, Luo H, Zhang M, Pei M, Song Y, Tornambe P, Goldbaum M, Ferreyra H, Kozak I, Zhang K. Common variant in VEGFA and response to anti-VEGF therapy for neovascular age-related macular degeneration. Curr Mol Med. 2013 Jul;13(6):929-34. doi: 10.2174/15665240113139990048. |
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Data not available for sharing.
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The Principal Investigator has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful due to all study team members having left the University. No study data are available, attempts were made to find the data but were unsuccessful.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lucentis | Consented, enrolled subjects will receive multiple open-label intravitreally administered 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months. Ranibizumab : Intravitreal injections of 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The Principal Investigator has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful due to all study team members having left the University. No study data are available, attempts were made to find the data but were unsuccessful.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lucentis | Consented, enrolled subjects will receive multiple open-label intravitreally administered 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months. Ranibizumab: Intravitreal injections of 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous |
| 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 | To Determine the Genotype at VEGF and HTRA1 SNPs of Patients Gaining ≥ 0 Letters of Visual Acuity in Response to Ranibizumab Treatment Over a 4 Month Period. | The Principal Investigator has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful due to all study team members having left the University. No study data are available, attempts were made to find the data but were unsuccessful. | Posted | 5 years |
|
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The Principal Investigator has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful due to all study team members having left the University. No study data are available, attempts were made to find the data but were unsuccessful.
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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 | Consented, enrolled subjects will receive multiple open-label intravitreally administered 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months. Ranibizumab : Intravitreal injections of 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months. |
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The PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful due to all study team members having left. No study data are available, attempts were made to find the data but were unsuccessful.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stuart Brown | University of California San Diego Shiley Eye Center | (858) 822-2585858-246-0814 | sibrown@ucsd.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 |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| To Determine the Mean Number of Injections Per Year Patients in the Study Require. | 5 years |
| Sex: Female, Male |
|
| Units | Counts |
|---|---|
| Participants |
|
| Secondary | To Determine the Genotype at VEGF and HTRA1 SNPs of Patients Who Lose Visual Acuity (Gain <0 Letters) at 4, 6 and 12 Months After Initial Treatment. | The Principal Investigator has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful due to all study team members having left the University. No study data are available, attempts were made to find the data but were unsuccessful. | Posted | 5 years |
|
|
| Secondary | To Determine Whether Change in Retinal Thickness is Correlated With Genotype | The Principal Investigator has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful due to all study team members having left the University. No study data are available, attempts were made to find the data but were unsuccessful. | Posted | 5 years |
|
|
| Secondary | To Determine the Mean Number of Injections Per Year Patients in the Study Require. | The Principal Investigator has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful due to all study team members having left the University. No study data are available, attempts were made to find the data but were unsuccessful. | Posted | 5 years |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |