Polypoidal Choroidal VasculopathyPhase 1PEARLNCT00424710
Ranibizumab for Polypoidal Choroidal Vasculopathy (PCV)
A Phase 1 study testing ranibizumab intravitreal injection in people with Polypoidal Choroidal Vasculopathy, run by Hawaii Pacific Health at 2 sites in United States.
Trial summary
This is a 12 month study of monthly injections of ranibizumab in subjects with polypoidal choroidal vasculopathy as diagnosed by fluoresceins/indocyanine green (FA/ICG) angiography. 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 intravitreal injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2007to Sep 2010
- 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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to provide informed consent and comply with study assessment for the duration of one year
- 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 20/32 to 20/400
Who cannot join
- Any history of previous vitrectomy
- Previous cataract or ocular surgery within 2 months of day 0
- Active intraocular inflammation in the study eye
- Active infections conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- Participation with another investigational drug within the past 30 days
- Prior sodium pegaptanib, verteporfin photodynamic therapy, intravitreal steroids, or bevacizumab within 30 days of study entry
- Blood pressure >180/110 (use of antihypertensives is allowed as long as hypertension can be controlled and is stable)
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Retina Center at Pali Momi
‘Aiea, Hawaii, 96701
Retina Consultants of Hawaii
Honolulu, Hawaii, 96817
About this study
Official title: Phase I Study of Ranibizumab Injection for Polypoidal Choroidal Vasculopathy (PEARL)
This is a 12 month study of monthly injections of ranibizumab in subjects with polypoidal choroidal vasculopathy as diagnosed by fluoresceins/indocyanine green (FA/ICG) angiography.
Read the detailed description
Previous treatment in subjects is allowed as long as appropriate washout period has elapsed. Patients will be followed by 4M ETDRS vision testing as well as scheduled OCT, ICG, FA and Fundus Photography.
- Conditions
- Polypoidal Choroidal Vasculopathy
- Being tested
- ranibizumab intravitreal injection
- Keywords
- choroidal neovascularization
- Medical subject headings
- Polypoidal Choroidal Vasculopathy, Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumab intravitreal injectionDrug
liquid, 0.5 mg ranibizumab intravitreally, once a month for 1 year
| Study group | Role | What they receive |
|---|---|---|
| Single Arm study | Other | Single arm study:
Drug: ranibizumab intravitreal injection liquid, 0.5 mg ranibizumab intravitreally, once a month for 1 year Receives: Drug: ranibizumab intravitreal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Measured by the proportion of subjects who lose fewer than 15 letters in visual acuity at 6 and 12 month compared with baseline
Measured: 1 year
Safety and Tolerability as measured by the recording and observations of adverse effects of study treatment
Measured: 1 Year
Secondary outcomes (5)
Efficacy as measured by the mean change from baseline in VA at 6 and 12 months
Measured: 1 Year
Efficacy as measured by the proportion of subjects who lose less than 5 letters of vision at month 6 and 12
Measured: 1 Year
Efficacy as mean change from baseline at 6 to 12 months in decreasing subretinal hemorrhage or subretinal exudates via fundus photographs and fundus exams
Measured: 1 Year
Efficacy as proportion of subjects with a decrease in size of the polypoidal vessels from PCV at Mo 6 and 12 as assessed by FA and ICG Angiography
Measured: 1 Year
Efficacy as proportion of subjects with a decrease in macular edema as measured by OCT in central or paracentral fields from baseline month 6 and month 12.
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 posted19 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 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, Principal investigator, The Retina Center at Pali Momi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424710
- Sponsor's protocol ID
- FVF3934s
- Acronym
- PEARL
- Status last verified
- Nov 2014
- First submitted
- 18 Jan 2007
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kokame GT, Yeung L, Lai JC. Continuous anti-VEGF treatment with ranibizumab for polypoidal choroidal vasculopathy: 6-month results. Br J Ophthalmol. 2010 Mar;94(3):297-301. doi: 10.1136/bjo.2008.150029. Epub 2009 Sep 1.
PubMed 19726427
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Ranibizumab Injection for Polypoidal Choroidal Vasculopathy (PEARL)
- ClinicalTrials.gov ID
- NCT00424710
- Acronym / sponsor ID
- PEARL / FVF3934s
- Conditions
- Polypoidal Choroidal Vasculopathy
- Keywords
- choroidal neovascularization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Hawaii Pacific HealthUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jan 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 19 Jan 2007 (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.
This is a 12 month study of monthly injections of ranibizumab in subjects with polypoidal choroidal vasculopathy as diagnosed by fluoresceins/indocyanine green (FA/ICG) angiography.
Detailed description
Previous treatment in subjects is allowed as long as appropriate washout period has elapsed. Patients will be followed by 4M ETDRS vision testing as well as scheduled OCT, ICG, FA and Fundus Photography.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm study | Other | Drug: ranibizumab intravitreal injectionSingle arm study: Drug: ranibizumab intravitreal injection liquid, 0.5 mg ranibizumab intravitreally, once a month for 1 year |
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 informed consent and comply with study assessment for the duration of one year
- 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 20/32 to 20/400
Key exclusion criteria (8 listed)
- Any history of previous vitrectomy
- Previous cataract or ocular surgery within 2 months of day 0
- Active intraocular inflammation in the study eye
- Active infections conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- Participation with another investigational drug within the past 30 days
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 intravitreal injectionliquid, 0.5 mg ranibizumab intravitreally, once a month for 1 year | Drug | Single Arm study |
Primary outcome
Efficacy Measured by the proportion of subjects who lose fewer than 15 letters in visual acuity at 6 and 12 month compared with baseline
Time frame: 1 year
Safety and Tolerability as measured by the recording and observations of adverse effects of study treatment
Time frame: 1 Year
5 secondary outcomes
Efficacy as measured by the mean change from baseline in VA at 6 and 12 months
Time frame: 1 Year
Efficacy as measured by the proportion of subjects who lose less than 5 letters of vision at month 6 and 12
Time frame: 1 Year
Efficacy as mean change from baseline at 6 to 12 months in decreasing subretinal hemorrhage or subretinal exudates via fundus photographs and fundus exams
Time frame: 1 Year
Efficacy as proportion of subjects with a decrease in size of the polypoidal vessels from PCV at Mo 6 and 12 as assessed by FA and ICG Angiography
Time frame: 1 Year
Efficacy as proportion of subjects with a decrease in macular edema as measured by OCT in central or paracentral fields from baseline month 6 and month 12.
Time frame: 1 Year
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 5 Nov 2014.
- Results publication: PubMed 19726427Kokame GT, Yeung L, Lai JC. Continuous anti-VEGF treatment with ranibizumab for polypoidal choroidal vasculopathy: 6-month results. Br J Ophthalmol. 2010 Mar;94(3):297-301. doi: 10.1136/bjo.2008.150029. Epub 2009 Sep 1.
Related trials for Polypoidal Choroidal Vasculopathy
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
RecruitingPhase 3
Safety and Efficacy Evaluation of SMZ1 With Ranibizumab in Patients With Neovascular Age-related Macular Degeneration Without Polypoidal Choroidal Vasculopathy
Neovascular (Wet) Age-related Macular Degeneration Without Polypoidal Choroidal Vasculopathy
RecruitingPhase 3
Efficacy and Durability of a Personalized Treat-and-extend Regimen of Faricimab for Treatment-naive Polypoidal Choroidal Vasculopathy
Polypoidal Choroidal Vasculopathy (PCV), Age Related Macular Degeneration
Active, not recruitingPhase 1/2
Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Intravitreal (IVT) Injection of ABI-110 (AAV2.N54-VEGF Trap) in Subjects With Neovascular (Wet) Age-Related Macular Degeneration (wAMD), Including Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV)
Neovascular (Wet) AMD
RecruitingPhase 4
Study to Investigate the Efficacy, Safety and Durability of Faricimab in Caucasian Patients With Polypoidal Choroidal Vasculopathy (MONDEGO)
Polypoidal Choroidal Vasculopathy
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 principal investigator
The Retina Center at Pali Momi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ranibizumab intravitreal injection in people with Polypoidal Choroidal Vasculopathy, run by Hawaii Pacific Health 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 8 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 5 Nov 2014. 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 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?
Efficacy Measured by the proportion of subjects who lose fewer than 15 letters in visual acuity at 6 and 12 month compared with baseline (time frame: 1 year). 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?
On the ClinicalTrials.gov record for NCT00424710, which also lists 1 linked publication.
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 5 Nov 2014.