Age-Related Macular DegenerationNCT02291887
Genetic Analysis of Patients Responsive to Ranibizumab But Resistant to Aflibercept
An observational study of Age-Related Macular Degeneration, run by Associated Retinal Consultants, Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- Ranibizumab and Aflibercept
- Type of treatment
- Injection or infusion
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2014to 1 Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Any other condition that the investigator believes would pose a significant hazard to the subject
Trial locations and contacts
1 site in 1 country.
United States1 site
Associated Retinal Consultants
Royal Oak, Michigan, 48073
About this study
Official title: Genetic Analysis of Patients With Neovascular Age-Related Macular Degeneration Responsive 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.
Read the detailed description
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.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- Ranibizumab, Aflibercept
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis
Intravitreal injection of Ranibizumab
AfliberceptDrug
Also called Eylea
Intravitreal injection of Aflibercept
| Study group | Role | What they receive |
|---|---|---|
| Neovascular ARMD Patients | Patients with Neovascular Age-Related Macular Degeneration Responsive to Ranibizumab but Resistant to Aflibercept Treatment Receives: Drug: Ranibizumab; Drug: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study start22 Dec 2014
- Primary completion1 Jul 2015
- Study completion1 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Associated Retinal Consultants, Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Jeremy D Wolfe, MD, MS, Principal investigator, Associated Retinal Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291887
- Sponsor's protocol ID
- ARCMichigan
- Status last verified
- Nov 2017
- First submitted
- 12 Nov 2014
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 12750101Rosenfeld 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.
PubMed 16935211Michels 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.
PubMed 16787141Rosenfeld 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.
PubMed 16581423Heier 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.
PubMed 16483659Feigl 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.
PubMed 16523231D'Amico DJ. Diseases of the retina. N Engl J Med. 1994 Jul 14;331(2):95-106. doi: 10.1056/NEJM199407143310207. No abstract available.
PubMed 8208273
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Analysis of Patients With Neovascular Age-Related Macular Degeneration Responsive to Ranibizumab But Resistant to Aflibercept
- ClinicalTrials.gov ID
- NCT02291887
- Acronym / sponsor ID
- ARCMichigan
- Conditions
- Age-Related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Associated Retinal Consultants, MichiganUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 22 Dec 2014 (actual)
- Primary completion
- 1 Jul 2015 (actual)
- Study completion
- 1 Jul 2015 (actual)
- First posted
- 17 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neovascular ARMD Patients | – | Drug: Ranibizumab, Drug: AfliberceptPatients with Neovascular Age-Related Macular Degeneration Responsive to Ranibizumab but Resistant to Aflibercept Treatment |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Subjects will be eligible if the following criteria are met:
Key exclusion criteria (1 listed)
- Any other condition that the investigator believes would pose a significant hazard to the subject
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RanibizumabAlso: LucentisIntravitreal injection of Ranibizumab | Drug | Neovascular ARMD Patients |
| AfliberceptAlso: EyleaIntravitreal injection of Aflibercept | Drug | Neovascular ARMD Patients |
Primary outcome
Genetic characteristics of patients responsive to Ranibizumab but Resistant to Aflibercept
Time frame: 1 day
To determine a genetic basis for patients responsive to ranibizumab but resistant to aflibercept.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Results publication: PubMed 12750101Eyetech 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.
- Results publication: PubMed 16935211Rosenfeld 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.
- Results publication: PubMed 16787141Michels 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.
- Results publication: PubMed 16581423Rosenfeld 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.
- Results publication: PubMed 16483659Heier 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.
- Results publication: PubMed 16523231Feigl 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.
- Results publication: PubMed 8208273D'Amico DJ. Diseases of the retina. N Engl J Med. 1994 Jul 14;331(2):95-106. doi: 10.1056/NEJM199407143310207. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy D Wolfe, MD, MS principal investigator
Associated Retinal Consultants
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-Related Macular Degeneration, run by Associated Retinal Consultants, Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic characteristics of patients responsive to Ranibizumab but Resistant to Aflibercept (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02291887, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.