Choroidal NeovascularizationPhase 1NCT00395551
Safety Study of Ranibizumab Eye Injections to Treat Choroidal Neovascularization That Was Caused Other Than by Age-Related Macular Degeneration.
A Phase 1 study testing ranibizumab in people with Choroidal Neovascularization, run by Ophthalmic Consultants of Boston.
Trial summary
The purpose of this study is to determine whether ranibizumab is effective in the treatment of choroidal neovascularization secondary to causes other then wet macular-degeneration. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Choroidal Neovascularization
- What is being tested?
- ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to Jun 2009
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- active choroidal neovascularization
Who cannot join
- pregnancy,age-related macular degeneration, current eye infection or recent eye surgery, participating in other eye studies
About this study
Official title: A Single Center Study of the Safety and Efficacy of Multiple Intravitreal Injections of Ranibizumab in Subjects With CNV Secondary to Causes Other Than AMD.
The purpose of this study is to determine whether ranibizumab is effective in the treatment of choroidal neovascularization secondary to causes other then wet macular-degeneration.
- Conditions
- Choroidal Neovascularization
- Being tested
- ranibizumab
- Keywords
- choroidal neovascularization, Choroidal Neovascularization Not related to Age-Related Macular Degeneration
- Medical subject headings
- Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumabDrug
0.5mg intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| ranibizumab | Active comparator | ranibizumab 0.5mg intravitreal injection Receives: Drug: ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measures for safety and tolerability
Measured: Mean change in visual acuity from baseline to 6 months & 12 months
Secondary outcomes (1)
The secondary outcome measures for efficacy
Measured: Mean change in visual acuity from baseline to 6 & 12 months. Change in retinal thickness from baseline to week 1, month 1, 2, 3, 6, & 12 measured by OCT. Change in area of CNV from baseline to month 3, 6 & 12 measured by FA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2006 (estimated)
- Study startDec 2005
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choroidal NeovascularizationStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ophthalmic Consultants of Boston
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Investigators
- Jeffrey S Heier, M.D., Principal investigator, Ophthalmic Consultants of Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00395551
- Sponsor's protocol ID
- FVF 3688 Non-AMD
- Status last verified
- Jan 2010
- First submitted
- 1 Nov 2006
- Last updated
- 8 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Study of the Safety and Efficacy of Multiple Intravitreal Injections of Ranibizumab in Subjects With CNV Secondary to Causes Other Than AMD.
- ClinicalTrials.gov ID
- NCT00395551
- Acronym / sponsor ID
- FVF 3688 Non-AMD
- Conditions
- Choroidal Neovascularization
- Keywords
- choroidal neovascularization, Choroidal Neovascularization Not related to Age-Related Macular Degeneration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ophthalmic Consultants of BostonUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Dec 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 3 Nov 2006 (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 ranibizumab is effective in the treatment of choroidal neovascularization secondary to causes other then wet macular-degeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ranibizumab | Active comparator | Drug: ranibizumabranibizumab 0.5mg intravitreal injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- active choroidal neovascularization
Key exclusion criteria (1 listed)
- pregnancy,age-related macular degeneration, current eye infection or recent eye surgery, participating in other eye studies
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 |
|---|---|---|
| ranibizumab0.5mg intravitreal injection | Drug | ranibizumab |
Primary outcome
The primary outcome measures for safety and tolerability
Time frame: Mean change in visual acuity from baseline to 6 months & 12 months
1 secondary outcome
The secondary outcome measures for efficacy
Time frame: Mean change in visual acuity from baseline to 6 & 12 months. Change in retinal thickness from baseline to week 1, month 1, 2, 3, 6, & 12 measured by OCT. Change in area of CNV from baseline to month 3, 6 & 12 measured by FA
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 Jan 2010.
Related trials for Choroidal Neovascularization
Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration
Neovascular Age Related Macular Degeneration(nAMD)
Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Neovascular Age-related Macular Degeneration
RecruitingPhase 2/3
A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002)
Macular Degeneration, Age-Related Macular Degeneration
Active, not recruiting
Speculum-Free Intravitreal Injection Using Cotton-Tipped Applicator Retraction: Pain, Procedure Time, Patient Satisfaction, and Safety
Neovascular Age-Related Macular Degeneration (nAMD), Diabetic Macular Edema
Active, not recruitingPhase 1/2
NG101 AAV Gene Therapy in Subjects With Wet Age-Related Macular Degeneration
Age-Related Macular Degeneration
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.
Jeffrey S Heier, M.D. principal investigator
Ophthalmic Consultants of Boston
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ranibizumab in people with Choroidal Neovascularization, run by Ophthalmic Consultants of Boston.
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 1 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 8 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
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 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.
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?
The primary outcome measures for safety and tolerability (time frame: Mean change in visual acuity from baseline to 6 months & 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 8 Jan 2010.