Polypoidal Choroidal VasculopathyPhase 1/2PEARL2NCT01248117
Safety Study of High-Dose Ranibizumab for Polypoidal Choroidal Vasculopathy
A Phase 1/2 study testing ranibizumab 2.0mg in people with Polypoidal Choroidal Vasculopathy, run by Retina Consultants of Hawaii at 2 sites in United States.
Trial summary
Monthly, continuous anti-vegf therapy for patients presenting with active polypoidal choroidal vasculopathy. Two arms, treatment naive and previously treated with an FDA approved anti-VEGF therapy, will be randomized and dosed with open label 2.0mg ranibizumab. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Polypoidal Choroidal Vasculopathy
- What is being tested?
- ranibizumab 2.0mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2010to Feb 2013
- 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 25 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 >= 25 years
- Polypoidal choroidal vasculopathy as noted on fluorescein and ICG angiography: active leakage, active bleeding or recent decrease in vision
- BVCA using ETDRS of 20/32 to 20/400
Who cannot join
- Any history of prior vitrectomy
- Any prior treatment with verteporfin PDT in the study eye
- Previous cataract surgery within the preceding 2 months of D0
- Active intraocular inflammation in the study eye
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- A condition, that in the opinion of the investigator, would preclude participation in the study (e.g. unstable medical status including blood pressure, cardiovascular disease)
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- Participation in another investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry.
- Prior anti-VEGF (Macugen, Avastin, Lucentis) in the study eye within 30 days prior to enrollment in this study
- Known allergy to any component in the study drug
- Uncontrolled hypertension: >180/110
- major surgery within 28 days prior to randomization
- Myocardial infarction, other cardia events requiring hospitalization within 6 months prior to randomization
- Systemic anti-VEGF or pro-VEGF within 3 months of randomization
- Pregnancy or lactation
- History of recurrent significant infections or bacterial infections
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Retina Consultants of Hawaii
‘Aiea, Hawaii, 96701
Jacqueline F Shen, 808-380-8060, jshen@retinahi.com
Gregg T Kokame, MD, MMM
- Recruiting
Retina Consultants of Hawaii, Inc
Honolulu, Hawaii, 96819
Jacqueline F Shen, 808-380-8060, jshen@retinahi.com
Gregg T Kokame, MD, MMM
About this study
Official title: Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab (2.0mg) Prospectively
Monthly, continuous anti-vegf therapy for patients presenting with active polypoidal choroidal vasculopathy. Two arms, treatment naive and previously treated with an FDA approved anti-VEGF therapy, will be randomized and dosed with open label 2.0mg ranibizumab.
Read the detailed description
Patients will be followed with spectral oct, 4m BCVA, ICG, FA and monthly eye examinations for one year.
- Conditions
- Polypoidal Choroidal Vasculopathy
- Being tested
- ranibizumab 2.0mg
- Keywords
- PCV, polypoidal, choroidal, vasculopathy
- Medical subject headings
- Polypoidal Choroidal Vasculopathy, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumab 2.0mgDrug
Monthly, intravitreal injection 0.05ml
| Study group | Role | What they receive |
|---|---|---|
| Previously Treated | Experimental | With prior anti-vegf therapy, only, no sooner than 30 days prior to enrollment into trial Receives: Drug: ranibizumab 2.0mg |
| Treatment-Naive | Experimental | Treatment-Naive: no previous treatment for PCV Receives: Drug: ranibizumab 2.0mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of intravitreal injections of 2.0mg ranibizumab administered monthly in preventing vision loss
To evaluate the efficacy of intravitreal injections of 2.0mg ranibizumab administered monthly in preventing vision loss, as measured by calculating the mean change in VA from baseline to Month 12
Measured: 1 year
Secondary outcomes (3)
To evaluate the safety and tolerability of intravitreal injections of 2.0mg ranibizumab administered monthly
To evaluate the safety and tolerability of intravitreal injections of 2.0mg ranibizumab administered monthly
Measured: 1 year
To evaluate the efficacy of monthly intravitreal injections of 2.0mg ranibizumab in preventing vision loss
To evaluate the efficacy of monthly intravitreal injections of 2.0mg ranibizumab in preventing vision loss as measured by the following: mean change from baseline in VA at 6 and 12 months, and the proportion of subjects who lose less than 5 letters of vision at Month 6 and Month 12.
Measured: 1 year
To investigate the efficacy of monthly intravitreal injections of 2.0mg ranibizumab on clinical findings associated with PCV
the mean change from baseline at M6 to M12 of subretinal hemorrhage and/or exudates via fundus photographs and fundus exams, decrease and/or complete resolution of branching vascular network from PCV at M3, M6, and M12 as assessed by FA and ICG, decrease and/or complete resolution of the branching vascular network (BVN) from PCV at M3, M6, and M12, as assessed by FA and ICG, mean change in central foveal thickness and/or peripapillary edema as measured by SD-OCT in central and/or paracentral fields from baseline, M3, M6 and M12, incidence of ocular AEs
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2012 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polypoidal Choroidal VasculopathyStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Retina Consultants of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Investigators
- Gregg T Kokame, MD, MMM, Principal investigator, Retina Consultants of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248117
- Sponsor's protocol ID
- FVF4929s
- Acronym
- PEARL2
- Status last verified
- Nov 2010
- First submitted
- 24 Nov 2010
- Last updated
- 25 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab (2.0mg) Prospectively
- ClinicalTrials.gov ID
- NCT01248117
- Acronym / sponsor ID
- PEARL2 / FVF4929s
- Conditions
- Polypoidal Choroidal Vasculopathy
- Keywords
- PCV, polypoidal, choroidal, vasculopathy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Retina Consultants of HawaiiUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Nov 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 25 Nov 2010 (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.
Monthly, continuous anti-vegf therapy for patients presenting with active polypoidal choroidal vasculopathy. Two arms, treatment naive and previously treated with an FDA approved anti-VEGF therapy, will be randomized and dosed with open label 2.0mg ranibizumab.
Detailed description
Patients will be followed with spectral oct, 4m BCVA, ICG, FA and monthly eye examinations for one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Previously Treated | Experimental | Drug: ranibizumab 2.0mgWith prior anti-vegf therapy, only, no sooner than 30 days prior to enrollment into trial |
| Treatment-Naive | Experimental | Drug: ranibizumab 2.0mgTreatment-Naive: no previous treatment for PCV |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age >= 25 years
- Polypoidal choroidal vasculopathy as noted on fluorescein and ICG angiography: active leakage, active bleeding or recent decrease in vision
- BVCA using ETDRS of 20/32 to 20/400
Key exclusion criteria (15 listed)
- Any history of prior vitrectomy
- Any prior treatment with verteporfin PDT in the study eye
- Previous cataract surgery within the preceding 2 months of D0
- Active intraocular inflammation in the study eye
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
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 2.0mgMonthly, intravitreal injection 0.05ml | Drug | Previously Treated, Treatment-Naive |
Primary outcome
To evaluate the efficacy of intravitreal injections of 2.0mg ranibizumab administered monthly in preventing vision loss
Time frame: 1 year
To evaluate the efficacy of intravitreal injections of 2.0mg ranibizumab administered monthly in preventing vision loss, as measured by calculating the mean change in VA from baseline to Month 12
3 secondary outcomes
To evaluate the safety and tolerability of intravitreal injections of 2.0mg ranibizumab administered monthly
Time frame: 1 year
To evaluate the efficacy of monthly intravitreal injections of 2.0mg ranibizumab in preventing vision loss
Time frame: 1 year
To investigate the efficacy of monthly intravitreal injections of 2.0mg ranibizumab on clinical findings associated with PCV
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2010.
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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.
Gregg T Kokame, MD, MMM principal investigator
Retina Consultants of Hawaii
2 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 2.0mg in people with Polypoidal Choroidal Vasculopathy, run by Retina Consultants of Hawaii at 2 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 4 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 25 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacqueline F Shen ((808) 380-8060, jshen@retinahi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of intravitreal injections of 2.0mg ranibizumab administered monthly in preventing vision loss (time frame: 1 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 25 Nov 2010.