Wet AMDNCT00804934
Investigates Improvement in Vision Following Switching From Avastin and Macugen Over to Lucentis
An observational study of Wet AMD, run by Retina Institute of Hawaii at 1 site in United States.
Trial summary
The purpose of this study is to determine whether people who have received intermittent anti-VEGF therapy have an improvement in vision after being switched to monthly injections of Lucentis. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Wet AMD
- What is being tested?
- Lucentis
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jan 2009
- 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
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 greater then and equal 50 years
- Patients with active neovascular AMD
- Received at least 3 treatments with anti-VEGF therapy (bevacizumab or pegaptanib or ranibizumab) in the last 24 months
- If the patient has bilateral disease and qualifies for the study, both eyes may be included
Who cannot join
- Subjects who meet any of the following criteria will be excluded from this study:
- Pregnancy or lactation
- Premenopausal women not using adequate contraception.
- Participation in another simultaneous medical investigation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study Intravitreally Admininstered Ranibizumab in 50 Subjects With AMD Having Received at Least 3 Doses of Intermittent Anti-VEGF Therapy in the Preceding 18 Months
The purpose of this study is to determine whether people who have received intermittent anti-VEGF therapy have an improvement in vision after being switched to monthly injections of Lucentis.
Read the detailed description
To determine mean change in visual acuity at 6 and 12 months
- Conditions
- Wet AMD
- Being tested
- Lucentis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LucentisDrug
0.5mg Lucentis every four months
| Study group | Role | What they receive |
|---|---|---|
| 0 | Not described Receives: Drug: Lucentis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in visual acuity at 6 and 12 months
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2008
- Study completionJan 2009
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
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Retina Institute of Hawaii
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Debra L Shimabukuro, RN, Study chair, Retina Institute of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804934
- Sponsor's protocol ID
- F4421S
- Status last verified
- May 2012
- First submitted
- 5 Dec 2008
- Last updated
- 28 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Intravitreally Admininstered Ranibizumab in 50 Subjects With AMD Having Received at Least 3 Doses of Intermittent Anti-VEGF Therapy in the Preceding 18 Months
- ClinicalTrials.gov ID
- NCT00804934
- Acronym / sponsor ID
- F4421S
- Conditions
- Wet AMD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Retina Institute of HawaiiUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Feb 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 9 Dec 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.
The purpose of this study is to determine whether people who have received intermittent anti-VEGF therapy have an improvement in vision after being switched to monthly injections of Lucentis.
Detailed description
To determine mean change in visual acuity at 6 and 12 months
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 0 | – | Drug: Lucentis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age greater then and equal 50 years
- Patients with active neovascular AMD
- Received at least 3 treatments with anti-VEGF therapy (bevacizumab or pegaptanib or ranibizumab) in the last 24 months
- If the patient has bilateral disease and qualifies for the study, both eyes may be included
Key exclusion criteria (4 listed)
- Subjects who meet any of the following criteria will be excluded from this study:
- Pregnancy or lactation
- Premenopausal women not using adequate contraception.
- Participation in another simultaneous medical investigation
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 |
|---|---|---|
| Lucentis0.5mg Lucentis every four months | Drug | 0 |
Primary outcome
Mean change in visual acuity at 6 and 12 months
Time frame: one 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 28 May 2012.
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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.
Debra L Shimabukuro, RN study chair
Retina Institute of Hawaii
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 Retina Institute of Hawaii 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 4 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 28 May 2012. 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?
Mean change in visual acuity at 6 and 12 months (time frame: one 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 28 May 2012.