PCVPhase 1/2PEARL2NCT01884597
Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab Prospectively (PEARL2)
A Phase 1/2 study testing high-dose ranibizumab and ranibizumab in people with PCV and Polypoidal Choroidal Vasculopathy, run by Hawaii Pacific Health at 3 sites in United States.
Trial summary
This is a 24-month study of ranibizumab (2.0 mg and 1.0 mg) in subjects with polypoidal choroidal vasculopathy as diagnosed by fluorescein/indocyanine green (FA/ICG) angiography. Read more about this study
- Who is it for?
- Ages 25 to 95 years
- Conditions the study is for
- PCV, Polypoidal Choroidal Vasculopathy
- What is being tested?
- high-dose ranibizumab and ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2010to Aug 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 25 to 95 years
- 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 > 25 years
- Polypoidal choroidal vasculopathy as noted on fluorescein and ICG angiography: active leakage, active bleeding or recent decrease in vision
- BCVA using ETDRS of 20/32 to 20/400
Who cannot join
- Any history of previous vitrectomy
- Any prior treatment with verteporfin photodynamic therapy in the study eye.
- Previous cataract surgery within the preceding 2 months of Day 0
- 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)
Show all 19Show fewer
- Participation in an 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-vascular endothelial growth factor (VEGF) (Macugen, Avastin, Lucentis) in the study eye prior within 30 days prior to enrollment in this study
- Known allergy to any component of the study drug
- Blood pressure >180/110 (systolic above 180 or diastolic above 110) If blood pressure if brought below 180/110 by anti-hypertensive treatment, the patient can become eligible.
- Major surgery within 28 days prior to randomization or major surgery planned within the next 12 months. Major surgery is defined as a surgical procedure that is more extensive than needle biopsy/aspiration placement of a central venous access device, removal/biopsy of a skin lesion, or placement of a peripheral venous catheter.
- Myocardial infraction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 6 months prior to randomization.
- Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomization.
- History of recurrent significant infections or bacterial infections
- Pregnancy (positive pregnancy test) or lactation
- Premenopausal women not using adequate contraception. The following are considered effective means of contraception, surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicide gel, an intra uterine device (IUD), or contraceptive hormone implant or patch
- Prior enrollment in the study
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Retina Consultants of Hawaii
‘Aiea, Hawaii, 96701
The Retina Center at Pali Momi
‘Aiea, Hawaii, 96701
Retina Consultants of Hawaii
Honolulu, Hawaii, 96817
About this study
Official title: Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab Prospectively
This is a 24-month study of ranibizumab (2.0 mg and 1.0 mg) in subjects with polypoidal choroidal vasculopathy as diagnosed by fluorescein/indocyanine green (FA/ICG) angiography.
- Conditions
- PCV, Polypoidal Choroidal Vasculopathy
- Being tested
- high-dose ranibizumab, ranibizumab
- Keywords
- PEARL2, PCV, Polypoidal Choroidal Vasculopathy
- Medical subject headings
- Polypoidal Choroidal Vasculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-dose ranibizumabDrug
20mg ranibizumab vials, 0.05ml injected intravitreally, monthly
ranibizumabDrug
Also called Lucentis
3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Active comparator | 12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab Receives: Drug: high-dose ranibizumab; Drug: ranibizumab |
| Cohort 2 | Active comparator | 6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg Receives: Drug: high-dose ranibizumab; Drug: ranibizumab |
| Cohort 3 | Active comparator | 24 months of monthly, intravitreal injections of ranibizumab 1.0mg Receives: Drug: ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCVA
Mean change in best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart at a starting test distance of 4 meters from Baseline to Month 12.
Measured: From Baseline to Month 12
BCVA
Mean change in best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters from Baseline to Month 24
Measured: Baseline to M24
Secondary outcomes (6)
Ocular Adverse Events (AE)
Incidence and severity of ocular adverse events, as identified by eye examination (including visual acuity testing)
Measured: Monthly
Systemic AEs
Incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs
Measured: Monthly
BCVA
Best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters, at Baseline, Day 14, Month 1, Month 3, Month 6, Month 9 , Month 12, Month 15, Month 18, Month 21 and Month 24
Measured: at Baseline, Day 14, Month 1, Month 3, Month 6, Month 9 , Month 12, Month 15, Month 18, Month 21 and Month 24
Macular Edema
Optical Coherence Tomography (OCT) central macular and peripapillary thickness
Measured: Baseline, Day 14, Month 1-24
PCV Anatomic Changes
Decrease and/or resolution in the branching vascular network of the PCV complex as measured by mean size of the branched vascular network (BVN) on ICG and fluorescein angiography
Decrease and/or resolution of the polyps of the PCV complex as measured on ICG and fluorescein angiography
Measured: Baseline, Months 6, 12, 24
Fundus Clinical Findings
Decrease in subretinal hemorrhage or exudates as measured by mean size as noted on fundus photography and clinic exam
Measured: Baseline, Months 6, 12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startNov 2010
- Primary completionAug 2014
- Study completionAug 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 PCVStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawaii Pacific Health
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Gregg T. Kokame, MD, Hawaii Pacific Health
- Investigators
- Gregg T Kokame, MD, MMM, Principal investigator, Hawaii Pacific Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884597
- Sponsor's protocol ID
- FVF4929S
- Acronym
- PEARL2
- Status last verified
- Sep 2017
- First submitted
- 1 Jun 2012
- Last updated
- 9 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. 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 Prospectively
- ClinicalTrials.gov ID
- NCT01884597
- Acronym / sponsor ID
- PEARL2 / FVF4929S
- Conditions
- PCV, Polypoidal Choroidal Vasculopathy
- Keywords
- PEARL2, PCV, Polypoidal Choroidal Vasculopathy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hawaii Pacific HealthUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Nov 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 24 Jun 2013 (estimated)
- Results
- Posted 11 Sep 2017
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 24-month study of ranibizumab (2.0 mg and 1.0 mg) in subjects with polypoidal choroidal vasculopathy as diagnosed by fluorescein/indocyanine green (FA/ICG) angiography.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Active comparator | Drug: high-dose ranibizumab, Drug: ranibizumab12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab |
| Cohort 2 | Active comparator | Drug: high-dose ranibizumab, Drug: ranibizumab6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg |
| Cohort 3 | Active comparator | Drug: ranibizumab24 months of monthly, intravitreal injections of ranibizumab 1.0mg |
Who may qualify
- Ages
- 25 to 95 years
- Sex
- All
- Healthy volunteers
- Not 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
- BCVA using ETDRS of 20/32 to 20/400
Key exclusion criteria (19 listed)
- Any history of previous vitrectomy
- Any prior treatment with verteporfin photodynamic therapy in the study eye.
- Previous cataract surgery within the preceding 2 months of Day 0
- 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 |
|---|---|---|
| high-dose ranibizumab20mg ranibizumab vials, 0.05ml injected intravitreally, monthly | Drug | Cohort 1, Cohort 2 |
| ranibizumabAlso: Lucentis3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
BCVA
Time frame: From Baseline to Month 12
Mean change in best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart at a starting test distance of 4 meters from Baseline to Month 12.
BCVA
Time frame: Baseline to M24
Mean change in best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters from Baseline to Month 24
6 secondary outcomes
Ocular Adverse Events (AE)
Time frame: Monthly
Systemic AEs
Time frame: Monthly
BCVA
Time frame: at Baseline, Day 14, Month 1, Month 3, Month 6, Month 9 , Month 12, Month 15, Month 18, Month 21 and Month 24
Macular Edema
Time frame: Baseline, Day 14, Month 1-24
PCV Anatomic Changes
Time frame: Baseline, Months 6, 12, 24
Fundus Clinical Findings
Time frame: Baseline, Months 6, 12, 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
- 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.
Gregg T Kokame, MD, MMM principal investigator
Hawaii Pacific Health
3 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 high-dose ranibizumab and ranibizumab in people with PCV and Polypoidal Choroidal Vasculopathy, run by Hawaii Pacific Health at 3 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 19 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 9 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 11 Sep 2017). 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?
BCVA (time frame: From Baseline to Month 12). The study lists 2 primary outcomes in all. 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 9 Oct 2017.