Age-Related Macular DegenerationFVF4154sNCT00791427
ERG/EOG Study in AMD Patients Treated With Ranibizumab
An observational study of Age-Related Macular Degeneration, run by Retina Center, Minnesota at 1 site in United States.
Trial summary
This is an open-label study assessing electrophysiologic testing of the retina with Electoretinogram (ERG) /Electrooculogram (EOG) tests in patients with exudative age-related macular degeneration (AMD). The standard FDA-approved treatment for wet AMD is ranibizumab (Lucentis). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- Ranibizumab
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Sep 2011
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will have AMD with choroidal neovascularization and above age 55 years.
Who may be able to join
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age >55 years
- Patients to be included in the study must have AMD with choroidal neovascularization
- BCVA between 20/20 - 20/400
- Lesion size less than or equal to 12 MPS disc areas
Who cannot join
- Prior treatment with an anti-VEGF agent within 6 months of enrollment in this study
- Pregnancy (positive pregnancy test)
- Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch
- Prior enrollment in the study
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial
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- Media insufficient to obtain a view
- Other causes of CNV not related to AMD
- Active ocular or peri-ocular infection
- Ocular surgery within 1 month prior to the study
Trial locations and contacts
1 site in 1 country.
About this study
This is an open-label study assessing electrophysiologic testing of the retina with Electoretinogram (ERG) /Electrooculogram (EOG) tests in patients with exudative age-related macular degeneration (AMD). The standard FDA-approved treatment for wet AMD is ranibizumab (Lucentis). This study focuses on the ERG and EOG tests to evaluate retinal responses to ranibizumab treatment in AMD.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- Ranibizumab
- 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
0.05 ml of ranibizumab injected into the eye monthly for one year
| Study group | Role | What they receive |
|---|---|---|
| AMD Patients | Not described Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ERG/EOG
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Retina Center, Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Abdhish R. Bhavsar, M.D., Retina Center, Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791427
- Sponsor's protocol ID
- FVF4154s
- Acronym
- FVF4154s
- Status last verified
- May 2015
- First submitted
- 13 Nov 2008
- Last updated
- 8 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ERG/EOG Study in AMD Patients Treated With Ranibizumab
- ClinicalTrials.gov ID
- NCT00791427
- Acronym / sponsor ID
- FVF4154s / FVF4154s
- Conditions
- Age-Related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Retina Center, MinnesotaUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Nov 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 14 Nov 2008 (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.
This is an open-label study assessing electrophysiologic testing of the retina with Electoretinogram (ERG) /Electrooculogram (EOG) tests in patients with exudative age-related macular degeneration (AMD). The standard FDA-approved treatment for wet AMD is ranibizumab (Lucentis). This study focuses on the ERG and EOG tests to evaluate retinal responses to ranibizumab treatment in AMD.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMD Patients | – | Drug: Ranibizumab |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will have AMD with choroidal neovascularization and above age 55 years.
Key inclusion criteria (5 listed)
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age >55 years
- Patients to be included in the study must have AMD with choroidal neovascularization
- BCVA between 20/20 - 20/400
- Lesion size less than or equal to 12 MPS disc areas
Key exclusion criteria (10 listed)
- Prior treatment with an anti-VEGF agent within 6 months of enrollment in this study
- Pregnancy (positive pregnancy test)
- Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch
- Prior enrollment in the study
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
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 |
|---|---|---|
| Ranibizumab0.05 ml of ranibizumab injected into the eye monthly for one year | Drug | AMD Patients |
Primary outcome
ERG/EOG
Time frame: 1 year
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 8 May 2015.
- facility websiteLink provided by the sponsor.
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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 Age-Related Macular Degeneration, run by Retina Center, Minnesota 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 5 inclusion and 10 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 8 May 2015. 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?
ERG/EOG (time frame: 1 year). 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 8 May 2015.