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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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A cohort of patients responsive to treatment with ranibizumab but resistant to
aflibercept were identified in a previously conducted retrospective study. Identified
patients will have their blood drawn for genome wide sequencing. The sequencing
data will be compiled and analyzed in an attempt to identify a common genetic basis
for patients susceptible to ranibizumab but resistant to aflibercept.
A cohort of patients responsive to treatment with ranibizumab but resistant to
aflibercept were identified in a previously conducted retrospective study. Identified
patients will have their blood drawn for genome wide sequencing. The sequencing
data will be compiled and analyzed in an attempt to identify a common genetic basis
for patients susceptible to ranibizumab but resistant to aflibercept.
Blood samples will be drawn for genetic analysis for all patients enrolled in the study.
The sample (1 tube- 6mL of blood) will be collected using - 8.5mL PAXgene Blood DNA
Tubes (http://www.qiagen.com/products/catalog/sample-technologies/dna-sample-
technologies/genomic-dna/paxgene-blood-dna-tubes).
Samples will be stored at -80 until time for analysis. Note that some blood draws will be performed at
satellite clinics and transported to main facility for storage in -80 freezer. It is the understanding of
ARC PI and staff that the PAXgene Blood DNA Tubes keep samples stable at room temp for 1-2
days.
However, staff will transport samples in timely fashion (room temp, on ice, dry ice,
etc), to -80 freezer for storage until all samples are collected. Once all samples are
collected, they will be shipped to Genentech for analysis. DNA extraction, the generation of genetic
data, and subsequent analysis will be performed at Genentech or via third party. DNA will be assayed
for polymorphisms through genome wide SNP chip or whole genome sequencing. The subject's
genotype or haplotype will be correlated with their visual response and OCT response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neovascular ARMD Patients | Patients with Neovascular Age-Related Macular Degeneration Responsive to Ranibizumab but Resistant to Aflibercept Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | Intravitreal injection of Ranibizumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Genetic characteristics of patients responsive to Ranibizumab but Resistant to Aflibercept | To determine a genetic basis for patients responsive to ranibizumab but resistant to aflibercept. | 1 day |
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Inclusion Criteria:
Subjects will be eligible if the following criteria are met:
Exclusion Criteria:
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17 subjects from approximately 1 site in the United States will be enrolled. Eligible subjects will be administered and provided with a copy of informed consent.
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| Name | Affiliation | Role |
|---|---|---|
| Jeremy D Wolfe, MD, MS | Associated Retinal Consultants | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Associated Retinal Consultants | Royal Oak | Michigan | 48073 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12750101 | Result | Eyetech Study Group. Anti-vascular endothelial growth factor therapy for subfoveal choroidal neovascularization secondary to age-related macular degeneration: phase II study results. Ophthalmology. 2003 May;110(5):979-86. doi: 10.1016/S0161-6420(03)00085-X. | |
| 16935211 | Result | Rosenfeld PJ, Rich RM, Lalwani GA. Ranibizumab: Phase III clinical trial results. Ophthalmol Clin North Am. 2006 Sep;19(3):361-72. doi: 10.1016/j.ohc.2006.05.009. |
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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 |
| C533178 | aflibercept |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Blood from each patient will be drawn for genetic analysis.
| Aflibercept | Drug | Intravitreal injection of Aflibercept |
|
|
| 16787141 | Result | Michels S, Schmidt-Erfurth U, Rosenfeld PJ. Promising new treatments for neovascular age-related macular degeneration. Expert Opin Investig Drugs. 2006 Jul;15(7):779-93. doi: 10.1517/13543784.15.7.779. |
| 16581423 | Result | Rosenfeld PJ, Heier JS, Hantsbarger G, Shams N. Tolerability and efficacy of multiple escalating doses of ranibizumab (Lucentis) for neovascular age-related macular degeneration. Ophthalmology. 2006 Apr;113(4):623.e1. doi: 10.1016/j.ophtha.2006.01.027. |
| 16483659 | Result | Heier JS, Antoszyk AN, Pavan PR, Leff SR, Rosenfeld PJ, Ciulla TA, Dreyer RF, Gentile RC, Sy JP, Hantsbarger G, Shams N. Ranibizumab for treatment of neovascular age-related macular degeneration: a phase I/II multicenter, controlled, multidose study. Ophthalmology. 2006 Apr;113(4):633.e1-4. doi: 10.1016/j.ophtha.2005.10.052. Epub 2006 Feb 14. |
| 16523231 | Result | Feigl B, Brown B, Lovie-Kitchin J, Lee L. Dynamics of retinal function after multiple photodynamic therapies in age-related macular degeneration: a report of cases. Doc Ophthalmol. 2005 Nov;111(3):135-48. doi: 10.1007/s10633-005-5319-7. Epub 2006 Mar 6. |
| 8208273 | Result | D'Amico DJ. Diseases of the retina. N Engl J Med. 1994 Jul 14;331(2):95-106. doi: 10.1056/NEJM199407143310207. No abstract available. |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |