Angioid StreaksPhase 1/2NCT01015495
Ranibizumab Therapy for Choroidal Neovascularization (CNV) Asociated With Angioid Streaks
A Phase 1/2 study testing ranibizumab in people with Angioid Streaks, run by University of Illinois Chicago.
Trial summary
The purpose of this study is to determine whether injections of ranibizumab into the eye are safe and well tolerated when given to subjects in multiple doses. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Angioid Streaks
- What is being tested?
- ranibizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to Jan 2011
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- 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 > 18 years
- Angioid streaks
- Subfoveal CNV of recent onset with the following characteristics
- Absence of subfoveal fibrosis
- Fibrosis less than 25% of the lesion
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- Presence of blood, subretinal fluid, and/or lipid
- New onset symptoms within 12 weeks
- Visual acuity 20/40 to 20/800 on an ETDRS chart
Who cannot join
- Prior treatment of subfoveal CNV in the study eye
- Age-related macular degeneration
- Uncontrolled glaucoma
- High myopia (> -10.00 D spherical equivalent)
- Prior retinal detachment
- Media opacity preventing adequate view of the retina
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- Planned cataract surgery in the next 3 months
- Current chemotherapy for cancer
- Immunocompromised state
- Pregnancy (positive pregnancy test) or lactation
- Premenopausal women not using adequate contraception.
- 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
- History of any previous treatment for angioid streaks
About this study
Official title: Ranibizumab Therapy for Choroidal Neovascularization Associated With Angioid Streaks
The purpose of this study is to determine whether injections of ranibizumab into the eye are safe and well tolerated when given to subjects in multiple doses.
Read the detailed description
Choroidal neovascularization is a hallmark of angioid streaks, and presumably VEGF-driven. Ranibizumab has been shown to be effective in CNV secondary to age-related macular degeneration. Therefore, we hypothesize that ranibizumab may be efficacious in the treatment of CNV secondary to angioid streaks
- Conditions
- Angioid Streaks
- Being tested
- ranibizumab
- Keywords
- angioid streaks, CNV, intra vitreal ranibizumab
- Medical subject headings
- Angioid Streaks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumabDrug
Also called Lucentis
0.5 mg dose of ranibizumab. Treatment will be given at baseline, month 1, and month 2, and then monthly until OCT shows absence of subretinal fluid and FA shows absence of leakage
| Study group | Role | What they receive |
|---|---|---|
| ranibizumab | Experimental | Not described 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 are the following: • Incidence and severity of ocular adverse events, as identified by eye examination (including visual acuity testing)
Measured: Month 12
Secondary outcomes (1)
Proportion of patients that lose fewer than 15 letters from baseline at months 6 and 12 as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters at months 6 and 12
Measured: Month 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2010 (estimated)
- Study completionJan 2011
Why it stopped: Not enough patients within the time frame to allow for a meaningful study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angioid StreaksStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Jennifer I. Lim, University of Illinois Chicago
- Investigators
- Jennifer I Lim, MD, Principal investigator, UIC Eye and Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015495
- Sponsor's protocol ID
- fvf 3763s
- Status last verified
- Jun 2012
- First submitted
- 17 Nov 2009
- Last updated
- 2 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ranibizumab Therapy for Choroidal Neovascularization Associated With Angioid Streaks
- ClinicalTrials.gov ID
- NCT01015495
- Acronym / sponsor ID
- fvf 3763s
- Conditions
- Angioid Streaks
- Keywords
- angioid streaks, CNV, intra vitreal ranibizumab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not enough patients within the time frame to allow for a meaningful study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Dec 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Jan 2011 (actual)
- First posted
- 18 Nov 2009 (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 injections of ranibizumab into the eye are safe and well tolerated when given to subjects in multiple doses.
Detailed description
Choroidal neovascularization is a hallmark of angioid streaks, and presumably VEGF-driven. Ranibizumab has been shown to be effective in CNV secondary to age-related macular degeneration. Therefore, we hypothesize that ranibizumab may be efficacious in the treatment of CNV secondary to angioid streaks
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ranibizumab | Experimental | Drug: ranibizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 18 years
- Angioid streaks
- Subfoveal CNV of recent onset with the following characteristics
- Absence of subfoveal fibrosis
Key exclusion criteria (14 listed)
- Prior treatment of subfoveal CNV in the study eye
- Age-related macular degeneration
- Uncontrolled glaucoma
- High myopia (> -10.00 D spherical equivalent)
- Prior retinal detachment
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 |
|---|---|---|
| ranibizumabAlso: Lucentis0.5 mg dose of ranibizumab. Treatment will be given at baseline, month 1, and month 2, and then monthly until OCT shows absence of subretinal fluid and FA shows absence of leakage | Drug | ranibizumab |
Primary outcome
The primary outcome measures for safety and tolerability are the following: • Incidence and severity of ocular adverse events, as identified by eye examination (including visual acuity testing)
Time frame: Month 12
1 secondary outcome
Proportion of patients that lose fewer than 15 letters from baseline at months 6 and 12 as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters at months 6 and 12
Time frame: Month 6 and 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2012.
- UIC-Ophthalmology home pageLink provided by the sponsor.
Related trials for Angioid Streaks
RecruitingObservational study
Progression Assessment of PXE-associated Alterations
Pseudoxanthoma Elasticum, Angioid Streaks
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.
Jennifer I Lim, MD principal investigator
UIC Eye and Ear Infirmary
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ranibizumab in people with Angioid Streaks, run by University of Illinois Chicago.
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 9 inclusion and 14 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: withdrawn, as of the sponsor's last update on 2 Jul 2012. 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 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 was withdrawn before enrolling participants, so there are no results.
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 are the following: • Incidence and severity of ocular adverse events, as identified by eye examination (including visual acuity testing) (time frame: Month 12). 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 2 Jul 2012.