Macular DegenerationPhase 1/2SALVAGENCT00467935
Scotoma Reduction in AMD Patients Treated With Ranibizumab
A Phase 1/2 study testing intravitreal injection Lucentis (ranibizumab) in people with Macular Degeneration, run by Retina Research Foundation at 1 site in United States.
Trial summary
This is a trial aimed at patients with advanced wet macular degeneration and macular scarring treated wiht intravitreal injections of Lucentis. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- intravitreal injection Lucentis (ranibizumab)
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Nov 2007
- Phase
- Phase 1/2
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BCVA < 20/320
- Disciform macular degeneration wiht exudation
Who cannot join
- Non-amd CNV
Trial locations and contacts
1 site in 1 country.
United States1 site
Retina Research Center
Slingerlands, New York, 12159
About this study
Official title: A Phase I/II Study to Evaluate Scotoma Reduction in And Limited Visual Acuity in aGe Related Macular Degeneration Patients Treated With Intravitreal Lucentis
This is a trial aimed at patients with advanced wet macular degeneration and macular scarring treated wiht intravitreal injections of Lucentis.
Read the detailed description
Patients with severe wet macular degeneration and scarring in the center of the retina may benefit from treatment if the size of the blind spot is reduced wiht injections of Lucentis.
- Conditions
- Macular Degeneration
- Being tested
- intravitreal injection Lucentis (ranibizumab)
- Keywords
- amd, disciform, fibrosis, Lucentis, scotoma
- Medical subject headings
- Macular Degeneration, Glycogen Storage Disease Type II, Fibrosis, Scotoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravitreal injection Lucentis (ranibizumab)Drug
intravitreal injection Lucentis (ranibizumab)
What is being measured
The primary outcome is the main question the study is designed to answer.
scotoma reduction
Measured: 12 months
Secondary outcomes (1)
improved visual function
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2007 (estimated)
- Study startMar 2007
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Retina Research Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Paul M Beer, MD, Principal investigator, Retina Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00467935
- Sponsor's protocol ID
- FVF3933
- Acronym
- SALVAGE
- Status last verified
- Jul 2011
- First submitted
- 29 Apr 2007
- Last updated
- 29 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study to Evaluate Scotoma Reduction in And Limited Visual Acuity in aGe Related Macular Degeneration Patients Treated With Intravitreal Lucentis
- ClinicalTrials.gov ID
- NCT00467935
- Acronym / sponsor ID
- SALVAGE / FVF3933
- Conditions
- Macular Degeneration
- Keywords
- amd, disciform, fibrosis, Lucentis, scotoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Retina Research FoundationUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 1 May 2007 (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 a trial aimed at patients with advanced wet macular degeneration and macular scarring treated wiht intravitreal injections of Lucentis.
Detailed description
Patients with severe wet macular degeneration and scarring in the center of the retina may benefit from treatment if the size of the blind spot is reduced wiht injections of Lucentis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BCVA < 20/320
- Disciform macular degeneration wiht exudation
Key exclusion criteria (1 listed)
- Non-amd CNV
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 |
|---|---|---|
| intravitreal injection Lucentis (ranibizumab)intravitreal injection Lucentis (ranibizumab) | Drug | – |
Primary outcome
scotoma reduction
Time frame: 12 months
1 secondary outcome
improved visual function
Time frame: 12 months
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 29 Jul 2011.
- sponsorLink 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.
Paul M Beer, MD principal investigator
Retina Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing intravitreal injection Lucentis (ranibizumab) in people with Macular Degeneration, run by Retina Research Foundation 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 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 29 Jul 2011. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
scotoma reduction (time frame: 12 months). 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 29 Jul 2011.