Genetic Analysis of Patients Responsive to Ranibizumab But Resistant to Aflibercept
Genetic Analysis of Patients With Neovascular Age-Related Macular Degeneration Responsive to Ranibizumab But Resistant to Aflibercept
1 other identifier
observational
13
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2014
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2014
CompletedFirst Posted
Study publicly available on registry
November 17, 2014
CompletedStudy Start
First participant enrolled
December 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedNovember 17, 2017
November 1, 2017
6 months
November 12, 2014
November 15, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Neovascular ARMD Patients
Patients with Neovascular Age-Related Macular Degeneration Responsive to Ranibizumab but Resistant to Aflibercept Treatment
Interventions
Intravitreal injection of Ranibizumab
Eligibility Criteria
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.
You may qualify if:
- Subjects will be eligible if the following criteria are met:
- Demonstrate worsening of exudation when switched from ranibizumab to aflibercept
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
You may not qualify if:
- Any other condition that the investigator believes would pose a significant hazard to the subject
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Associated Retinal Consultants, Michiganlead
- Genentech, Inc.collaborator
Study Sites (1)
Associated Retinal Consultants
Royal Oak, Michigan, 48073, United States
Related Publications (7)
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.
PMID: 12750101RESULTRosenfeld 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.
PMID: 16935211RESULTMichels 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.
PMID: 16787141RESULTRosenfeld 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.
PMID: 16581423RESULTHeier 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.
PMID: 16483659RESULTFeigl 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.
PMID: 16523231RESULTD'Amico DJ. Diseases of the retina. N Engl J Med. 1994 Jul 14;331(2):95-106. doi: 10.1056/NEJM199407143310207. No abstract available.
PMID: 8208273RESULT
Biospecimen
Blood from each patient will be drawn for genetic analysis.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeremy D Wolfe, MD, MS
Associated Retinal Consultants
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2014
First Posted
November 17, 2014
Study Start
December 22, 2014
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
November 17, 2017
Record last verified: 2017-11