Branch Retinal Vein OcclusionPhase 1/2RAVENNCT01471691
Intravitreal Ranibizumab 0.5MG, or 1.0mg for RVO With Macular Edema Previously Receiving Bevacizumab
A Phase 1/2 study testing ranibizumab 0.5mg and ranibizumab 1.0mg in people with Branch Retinal Vein Occlusion and Central Retinal Vein Occlusion, run by Hanscom, Thomas, M.D. at 4 sites in United States.
Trial summary
This study examines two doses of Ranibizumab (0.5mg and 1.0mg) for the treatment of macular edema secondary to retinal vein occlusion in patients that have previously failed treatment with other macular edema treatments including bevacizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, Macular Edema
- What is being tested?
- ranibizumab 0.5mg and ranibizumab 1.0mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2011to Feb 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- 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
- CRVO or BRVO diagnosis
- For CRVO, clinical evidence of perfused central retinal vein occlusion. A CRVO is defined as an eye that has retinal hemorrhages and a dilated retinal venous system in all 4 quadrants. Other evidence of a CRVO may include telangiectatic capillary bed and collateral vessels at the optic nerve head.
- Central macular edema present on clinical examination and OCT testing with a central point thickness and/or central 1mm subfield thickness > 300 microns after at least 3 months of bevacizumab or steroid therapy.
- Visual acuity score greater than or equal to 19 letters (20/400) and less than or equal to 73 letters (20/40) by the ETDRS visual acuity protocol.
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- Patients must demonstrate that they are no longer improving on bevacizumab or intravitreal steroid therapy (i.e. no improvement in acuity in 2 consecutive visits)
- BRVO patients treated with grid laser must show residual edema three months following latest laser treatment
- Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography
Who cannot join
- Pregnancy (positive pregnancy test) or known to be pregnant; also pre-menopausal women not using adequate contraception.
- Participation in another ocular investigation or trial simultaneously
- Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g. chronic alcoholism, drug abuse)
- Significant diabetic retinopathy (greater than moderate NPDR) or macular edema associated with diabetic retinopathy
- An eye that, in the investigator's opinion, has no chance of improving in visual acuity following resolution of macular edema (e.g. presence of subretinal fibrosis or geographic atrophy or severe epiretinal membrane)
- Presence of another ocular condition that may affect the visual acuity or macular edema during the course of the study (e.g. AMD, uveitis, Irvine-Gas)
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- Evidence of neovascularization of the iris or retina (presence of ischemic CRVO/BRVO)
- Evidence of central atrophy or fibrosis in the study eye
- Presence of substantial cataract, one that might decrease the vision by 3 or more lines of vision at sometime during the study.
- History of grid/focal laser or panretinal laser in the study eye in the previous three months
- History of vitreous surgery in the study eye
- History of use of intravitreal, peribulbar, or retrobulbar steroids within three months of the study.
- History of cataract surgery within 6 months of enrollment.
- History of YAG capsulotomy within 2 months of the surgery.
- Visual acuity <20/400 in the fellow eye
- Uncontrolled glaucoma (pressure >30) despite treatment with glaucoma medications.
- History of cerebral vascular accident or myocardial infarction within 3 months prior to Day 0.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
South Coast Retina
Huntington Beach, California, 92647
South Coast Retina
Long Beach, California, 90807
Thomas Hanscom AMC
Santa Monica, California, 90404
South Coast Retina
Torrance, California, 90505
About this study
Official title: Phase I/II, Open-label, Study of Intravitreal RAnibizumab 0.5MG, or High Dose 1.0mg for Retinal Vein Occlusions With rEfractory Macular Edema Previously Receiving iNtravitreal Bevacizumab (RAVEN)
This study examines two doses of Ranibizumab (0.5mg and 1.0mg) for the treatment of macular edema secondary to retinal vein occlusion in patients that have previously failed treatment with other macular edema treatments including bevacizumab.
- Being tested
- ranibizumab 0.5mg, ranibizumab 1.0mg
- Medical subject headings
- Retinal Vein Occlusion, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumab 0.5mgDrug
Also called Lucentis
Standard dose
ranibizumab 1.0mgDrug
Also called Lucentis
High dose
| Study group | Role | What they receive |
|---|---|---|
| intravitreal ranibizumab 0.5mg | Experimental | Not described Receives: Drug: ranibizumab 0.5mg |
| intravitreal ranibizumab 1.0mg | Experimental | Not described Receives: Drug: ranibizumab 1.0mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline BCVA
Vision was measured using a standard ETDRS chart at baseline and each subsequent monthly visit.
Measured: Baseline to month 6
Secondary outcomes (5)
Mean Change From Baseline in Center Point Thickness
Measured: months 1-12
Change in Mean Best Corrected Visual Acuity From Baseline
Measured: months 1-12
Percentage of Patients With CFT Less Than 300um
Measured: Month 6 and 12
Excess Foveal Thickness
Measured: Month 6 and 12
Total Number of Ranibizumab Injections
Measured: month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Branch Retinal Vein OcclusionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanscom, Thomas, M.D.
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Thomas O'Hearn, MD, Principal investigator, Thomas Hanscom AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471691
- Sponsor's protocol ID
- ML27847
- Acronym
- RAVEN
- Status last verified
- Apr 2015
- First submitted
- 9 Nov 2011
- Last updated
- 29 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II, Open-label, Study of Intravitreal RAnibizumab 0.5MG, or High Dose 1.0mg for Retinal Vein Occlusions With rEfractory Macular Edema Previously Receiving iNtravitreal Bevacizumab (RAVEN)
- ClinicalTrials.gov ID
- NCT01471691
- Acronym / sponsor ID
- RAVEN / ML27847
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hanscom, Thomas, M.D.
- Collaborators
- Genentech, Inc.
- Study start
- Nov 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 16 Nov 2011 (estimated)
- Results
- Posted 29 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines two doses of Ranibizumab (0.5mg and 1.0mg) for the treatment of macular edema secondary to retinal vein occlusion in patients that have previously failed treatment with other macular edema treatments including bevacizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intravitreal ranibizumab 0.5mg | Experimental | Drug: ranibizumab 0.5mg |
| intravitreal ranibizumab 1.0mg | Experimental | Drug: ranibizumab 1.0mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not 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
- CRVO or BRVO diagnosis
- For CRVO, clinical evidence of perfused central retinal vein occlusion. A CRVO is defined as an eye that has retinal hemorrhages and a dilated retinal venous system in all 4 quadrants. Other evidence of a CRVO may include telangiectatic capillary bed and collateral vessels at the optic nerve head.
- Central macular edema present on clinical examination and OCT testing with a central point thickness and/or central 1mm subfield thickness > 300 microns after at least 3 months of bevacizumab or steroid therapy.
Key exclusion criteria (17 listed)
- Pregnancy (positive pregnancy test) or known to be pregnant; also pre-menopausal women not using adequate contraception.
- Participation in another ocular investigation or trial simultaneously
- Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g. chronic alcoholism, drug abuse)
- Significant diabetic retinopathy (greater than moderate NPDR) or macular edema associated with diabetic retinopathy
- An eye that, in the investigator's opinion, has no chance of improving in visual acuity following resolution of macular edema (e.g. presence of subretinal fibrosis or geographic atrophy or severe epiretinal membrane)
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 |
|---|---|---|
| ranibizumab 0.5mgAlso: LucentisStandard dose | Drug | intravitreal ranibizumab 0.5mg |
| ranibizumab 1.0mgAlso: LucentisHigh dose | Drug | intravitreal ranibizumab 1.0mg |
Primary outcome
Mean Change From Baseline BCVA
Time frame: Baseline to month 6
Vision was measured using a standard ETDRS chart at baseline and each subsequent monthly visit.
5 secondary outcomes
Mean Change From Baseline in Center Point Thickness
Time frame: months 1-12
Change in Mean Best Corrected Visual Acuity From Baseline
Time frame: months 1-12
Percentage of Patients With CFT Less Than 300um
Time frame: Month 6 and 12
Excess Foveal Thickness
Time frame: Month 6 and 12
Total Number of Ranibizumab Injections
Time frame: month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Thomas O'Hearn, MD principal investigator
Thomas Hanscom AMC
4 sites 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 ranibizumab 0.5mg and ranibizumab 1.0mg in people with Branch Retinal Vein Occlusion and Central Retinal Vein Occlusion, run by Hanscom, Thomas, M.D. at 4 sites 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 9 inclusion and 17 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 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 29 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Baseline BCVA (time frame: Baseline to month 6). 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 Apr 2015.