Wet AMDNCT01310686
Genetics Study of Wet Age-Related Macular Degeneration (AMD) Non-Responders to Vascular Endothelial Growth Factor (VEGF) Therapy
An observational study of Wet AMD, run by West Coast Retina Medical Group, Inc. at 1 site in United States.
Trial summary
To obtain a genotypic analysis of patients with chronic exudative age-related macular degeneration noted to have subretinal or intraretinal edema despite continuous monthly Anti-VEGF therapy. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Wet AMD
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jun 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients diagnosed with Wet Age-Related Macular Degeneration
Who may be able to join
- Ability to provide written informed consent for participation in this study
- Subjects diagnoses of neovascular AMD who are on a monthly anti-VEGF regimen (have had >10 or more ranibizumab and/or bevacizumab injections within the last year) and who still have intra-retinal or subretinal fluid as confirmed by the Investigator
Who cannot join
- Subjects with a Pigment Epithelial Detachment Exclusively
- Subjects with Serous Pigment Epithelial Detachments
- Subjects with history of the following:
- idiopathic polypoidal choroidal vasculopathy
- pathologic degenerative myopia
- central serous chorioretinopathy
- familial drusen
- adult onset foveal pattern dystrophy
Trial locations and contacts
1 site in 1 country.
United States1 site
West Coast Retina Medical Group, Inc.
San Francisco, California, 94109
About this study
Official title: Genotypic Evaluation of Chronic Exudative Macular Degeneration Despite Monthly Anti-Vascular Endothelial Growth Factor (VEGF) Therapy
To obtain a genotypic analysis of patients with chronic exudative age-related macular degeneration noted to have subretinal or intraretinal edema despite continuous monthly Anti-VEGF therapy.
- Conditions
- Wet AMD
- Keywords
- wet AMD anti-VEGF, Genetic analysis of patients with Wet AMD who have not responded fully to anti-VEGF treatments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Wet AMD Non-Responders to Anti-VEGF | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic analysis of patients with chronic wet age-related macular degeneration despite continuous anti-VEGF treatment
Measured: This is a one time only blood draw.
Secondary outcomes (1)
To evaluate demographic and clinical characteristics in patients treated with anti-VEGF therapy who fail to respond completely.
Measured: This is a one time only blood draw and assessment of clinical characteristics.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet AMDStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Coast Retina Medical Group, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Arthur D. Fu, MD, West Coast Retina Medical Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310686
- Sponsor's protocol ID
- FVF4990s
- Status last verified
- Oct 2018
- First submitted
- 7 Mar 2011
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genotypic Evaluation of Chronic Exudative Macular Degeneration Despite Monthly Anti-Vascular Endothelial Growth Factor (VEGF) Therapy
- ClinicalTrials.gov ID
- NCT01310686
- Acronym / sponsor ID
- FVF4990s
- Conditions
- Wet AMD
- Keywords
- wet AMD anti-VEGF, Genetic analysis of patients with Wet AMD who have not responded fully to anti-VEGF treatments
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- West Coast Retina Medical Group, Inc.University, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Apr 2011
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 8 Mar 2011 (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.
To obtain a genotypic analysis of patients with chronic exudative age-related macular degeneration noted to have subretinal or intraretinal edema despite continuous monthly Anti-VEGF therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wet AMD Non-Responders to Anti-VEGF | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with Wet Age-Related Macular Degeneration
Key inclusion criteria (2 listed)
- Ability to provide written informed consent for participation in this study
- Subjects diagnoses of neovascular AMD who are on a monthly anti-VEGF regimen (have had >10 or more ranibizumab and/or bevacizumab injections within the last year) and who still have intra-retinal or subretinal fluid as confirmed by the Investigator
Key exclusion criteria (8 listed)
- Subjects with a Pigment Epithelial Detachment Exclusively
- Subjects with Serous Pigment Epithelial Detachments
- Subjects with history of the following:
- idiopathic polypoidal choroidal vasculopathy
- pathologic degenerative myopia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genetic analysis of patients with chronic wet age-related macular degeneration despite continuous anti-VEGF treatment
Time frame: This is a one time only blood draw.
1 secondary outcome
To evaluate demographic and clinical characteristics in patients treated with anti-VEGF therapy who fail to respond completely.
Time frame: This is a one time only blood draw and assessment of clinical characteristics.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Wet AMD, run by West Coast Retina Medical Group, Inc. 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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 12 Oct 2018. 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?
Results are not available in the source record.
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 analysis of patients with chronic wet age-related macular degeneration despite continuous anti-VEGF treatment (time frame: This is a one time only blood draw.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Oct 2018.