Polypoidal Choroidal VasculopathyPhase 1/2NCT00837330
Ranibizumab (Lucentis) for Polypoidal Choroidal Vasculopathy
A Phase 1/2 study testing ranibizumab 0.5 or 0.3 mg/0.05 cc in people with Polypoidal Choroidal Vasculopathy, run by Southeast Retina Center, Georgia at 1 site in United States.
Trial summary
This Phase I/II safety study is designed to investigate the safety and efficacy of ranibizumab (Lucentis) in the treatment of polypoidal choroidal vasculopathy (PCV), a potentially blinding eye disease that involves the growth of tiny, abnormal blood vessels under the retina. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Polypoidal Choroidal Vasculopathy
- What is being tested?
- ranibizumab 0.5 or 0.3 mg/0.05 cc
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Dec 2010
- 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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >35 years
- Exudative, active PCV in 1 eye.
- PCV is defined as choroidal neovascularization that displays occult characteristics on fluorescein angiography and polypoidal interconnecting vascular channels with saccular dilatations on indocyanine green angiography and/or fluorescein angiography.
Who cannot join
- Age <35 years
- Prior treatment with non-ranibizumab therapies (e.g., laser, surgery, or bevacizumab)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Polypoidal Choroidal Vasculopathy With Ranibizumab(Lucentis): A Phase I/II Safety Study.
This Phase I/II safety study is designed to investigate the safety and efficacy of ranibizumab (Lucentis) in the treatment of polypoidal choroidal vasculopathy (PCV), a potentially blinding eye disease that involves the growth of tiny, abnormal blood vessels under the retina. These abnormal blood vessels can bleed or leak fluid, causing disruption of normal retinal function and vision loss. Ranibizumab is a drug that is FDA-approved for the treatment of wet age-related macular degeneration (AMD) and is injected directly into the eye. Given the efficacy of ranibizumab in the treatment of wet AMD, and the postulated similarity between the disease mechanisms involved in both wet AMD and PCV, we believe ranibizumab will have a beneficial effect on visual function in patients with PCV.
Read the detailed description
Please see above description. Phase I/II safety study; prospective, open-label, single-center, non-randomized, uncontrolled, consecutive interventional case series. Enrolled patients are >35 years old and display exudative, active polypoidal choroidal vasculopathy (PCV) in 1 eye. PCV is defined as choroidal neovascularization that displays occult characteristics on fluorescein angiography and polypoidal interconnecting vascular channels with saccular dilatations on indocyanine green angiography and/or fluorescein angiography. Eyes receive 3 consecutive, monthly intravitreal ranibizumab injections (0.5 mg or 0.3 mg/0.05 cc) followed by monthly evaluations with the option of additional intravitreal ranibizumab or alternative treatments at the discretion of the investigator. Baseline and follow-up evaluations include medical history, blood pressure, physical examination, early treatment diabetic rentinopathy study (ETDRS) best-corrected visual acuity (BCVA), intraocular pressure measurement, complete ophthalmologic examination, fundus photography, fluorescein/ indocyanine green (ICG) angiography, and optical coherence tomography (OCT).
- Conditions
- Polypoidal Choroidal Vasculopathy
- Being tested
- ranibizumab 0.5 or 0.3 mg/0.05 cc
- Keywords
- polypoidal choroidal vasculopathy, choroidal neovascularization, ranibizumab, Lucentis
- 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 0.5 or 0.3 mg/0.05 ccDrug
Also called Lucentis
ranibizumab 0.5 or 0.3 mg/0.05 cc administered intraocularly on a monthly basis for 3 months, followed by monthly examination with the option of further ranibizumab treatment or other therapies at the discretion of the treating physician
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab 0.5 mg/ 0.05 cc | Experimental | Intraocular injection of 0.5 mg/ 0.05 cc ranibizumab Receives: Drug: ranibizumab 0.5 or 0.3 mg/0.05 cc |
| Ranibizumab 0.3 mg/ 0.05 cc | Experimental | Intraocular injection of 0.3 mg/ 0.05 cc ranibizumab Receives: Drug: ranibizumab 0.5 or 0.3 mg/0.05 cc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Commonly Reported and Notable Adverse Events
Incidence and severity of ocular adverse events, as identified by indirect and direct examination. Examples include 30 letter loss, major subretinal hemorrhage, involving 75% or more of clinical macula (arcade to arcade), disease-related vitreous hemorrhage, injection-related endopthalmitis, retinal detachment, vitreous hemorrhage, study drug/procedure related uveitis, incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startMay 2006
- Primary completionDec 2010
- Study completionDec 2010
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast Retina Center, Georgia
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Dennis M. Marcus, M.D., Southeast Retina Center, Georgia
- Investigators
- Dennis M. Marcus, M.D., Principal investigator, Southeast Retina Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837330
- Sponsor's protocol ID
- FVF3761s
- Status last verified
- Apr 2019
- First submitted
- 4 Feb 2009
- Last updated
- 16 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Marcus DM, Singh H, Lott MN, Singh J, Marcus MD. Intravitreal ranibizumab for polypoidal choroidal vasculopathy in non-Asian patients. Retina. 2013 Jan;33(1):35-47. doi: 10.1097/IAE.0b013e3182618be0.
PubMed 22990319
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Polypoidal Choroidal Vasculopathy With Ranibizumab(Lucentis): A Phase I/II Safety Study.
- ClinicalTrials.gov ID
- NCT00837330
- Acronym / sponsor ID
- FVF3761s
- Conditions
- Polypoidal Choroidal Vasculopathy
- Keywords
- polypoidal choroidal vasculopathy, choroidal neovascularization, ranibizumab, Lucentis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Southeast Retina Center, GeorgiaUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- May 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 5 Feb 2009 (estimated)
- Results
- Posted 23 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase I/II safety study is designed to investigate the safety and efficacy of ranibizumab (Lucentis) in the treatment of polypoidal choroidal vasculopathy (PCV), a potentially blinding eye disease that involves the growth of tiny, abnormal blood vessels under the retina. These abnormal blood vessels can bleed or leak fluid, causing disruption of normal retinal function and vision loss. Ranibizumab is a drug that is FDA-approved for the treatment of wet age-related macular degeneration (AMD) and is injected directly into the eye. Given the efficacy of ranibizumab in the treatment of wet AMD, and the postulated similarity between the disease mechanisms involved in both wet AMD and PCV, we believe ranibizumab will have a beneficial effect on visual function in patients with PCV.
Detailed description
Please see above description. Phase I/II safety study; prospective, open-label, single-center, non-randomized, uncontrolled, consecutive interventional case series. Enrolled patients are >35 years old and display exudative, active polypoidal choroidal vasculopathy (PCV) in 1 eye. PCV is defined as choroidal neovascularization that displays occult characteristics on fluorescein angiography and polypoidal interconnecting vascular channels with saccular dilatations on indocyanine green angiography and/or fluorescein angiography. Eyes receive 3 consecutive, monthly intravitreal ranibizumab injections (0.5 mg or 0.3 mg/0.05 cc) followed by monthly evaluations with the option of additional intravitreal ranibizumab or alternative treatments at the discretion of the investigator. Baseline and follow-up evaluations include medical history, blood pressure, physical examination, early treatment diabetic rentinopathy study (ETDRS) best-corrected visual acuity (BCVA), intraocular pressure measurement, complete ophthalmologic examination, fundus photography, fluorescein/ indocyanine green (ICG) angiography, and optical coherence tomography (OCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab 0.5 mg/ 0.05 cc | Experimental | Drug: ranibizumab 0.5 or 0.3 mg/0.05 ccIntraocular injection of 0.5 mg/ 0.05 cc ranibizumab |
| Ranibizumab 0.3 mg/ 0.05 cc | Experimental | Drug: ranibizumab 0.5 or 0.3 mg/0.05 ccIntraocular injection of 0.3 mg/ 0.05 cc ranibizumab |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >35 years
- Exudative, active PCV in 1 eye.
- PCV is defined as choroidal neovascularization that displays occult characteristics on fluorescein angiography and polypoidal interconnecting vascular channels with saccular dilatations on indocyanine green angiography and/or fluorescein angiography.
Key exclusion criteria (2 listed)
- Age <35 years
- Prior treatment with non-ranibizumab therapies (e.g., laser, surgery, or bevacizumab)
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 0.5 or 0.3 mg/0.05 ccAlso: Lucentisranibizumab 0.5 or 0.3 mg/0.05 cc administered intraocularly on a monthly basis for 3 months, followed by monthly examination with the option of further ranibizumab treatment or other therapies at the discretion of the treating physician | Drug | Ranibizumab 0.3 mg/ 0.05 cc, Ranibizumab 0.5 mg/ 0.05 cc |
Primary outcome
Commonly Reported and Notable Adverse Events
Time frame: 2 years
Incidence and severity of ocular adverse events, as identified by indirect and direct examination. Examples include 30 letter loss, major subretinal hemorrhage, involving 75% or more of clinical macula (arcade to arcade), disease-related vitreous hemorrhage, injection-related endopthalmitis, retinal detachment, vitreous hemorrhage, study drug/procedure related uveitis, incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22990319Marcus DM, Singh H, Lott MN, Singh J, Marcus MD. Intravitreal ranibizumab for polypoidal choroidal vasculopathy in non-Asian patients. Retina. 2013 Jan;33(1):35-47. doi: 10.1097/IAE.0b013e3182618be0.
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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.
Dennis M. Marcus, M.D. principal investigator
Southeast Retina Center
1 site 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 0.5 or 0.3 mg/0.05 cc in people with Polypoidal Choroidal Vasculopathy, run by Southeast Retina Center, Georgia at 1 site 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 3 inclusion and 2 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 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 23 Jun 2014). 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?
Commonly Reported and Notable Adverse Events (time frame: 2 years). 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 NCT00837330, 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 16 Apr 2019.