Polypoidal Choroidal VasculopathyPhase 2NCT01023295
Study Evaluating the Safety and Response of Fosbretabulin in Asian Patients With Polypoidal Choroidal Vasculopathy (PCV)
A Phase 2 study testing fosbretabulin and Saline in people with Polypoidal Choroidal Vasculopathy, run by Mateon Therapeutics at 5 sites in 5 countries.
Trial summary
The primary objective of this study is to examine effects of fosbretabulin tromethamine (fosbretabulin) on PCV as reflected by a change from baseline in the number of polypoid lesions on indocyanine green angiography (ICGA). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Polypoidal Choroidal Vasculopathy
- What is being tested?
- fosbretabulin and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Jul 2009to Aug 2010
- Phase
- Phase 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female age ≥21 years.
- Asian race (e.g. Chinese, Japanese, Korean, Thai).
- Polypoidal choroidal vasculopathy in the study eye
- Presence of ≥ 1 visible polypoidal varicosity on ICGA.
- Presence of a measurable branching vascular network
- BCVA by ETDRS of 68 to 4 letters in the study eye.
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- Ophthalmologic Exclusion Criteria
- Prior treatment with intravitreal or systemic anti-VEGF therapy within 60 days of enrollment.
- Any other prior treatment for PCV including thermal laser photocoagulation, photodynamic therapy (i.e., verteporfin), or any investigational therapies.
- Any history of prior retinal or subretinal surgery, transpupillary thermography, radiation, implantation of intravitreal drug delivery device, vitrectomy.
- Any other intraocular surgery or laser treatment within 90 days or any surgeries planned during the study period.
- Fibrosis involving ≥50% of the total lesion.
- Presence of hemorrhage which potentially obscures >75% of vascular pathology to be assessed by imaging procedures.
- Retinal or choroidal vascular disease in study eye due to causes other than PCV, such as uveitis, trauma, or pathologic myopia.
- Macular edema in either eye due to other causes, such as diabetic retinopathy.
- Evidence of glaucomatous eye disease, glaucomatous visual field loss.
- History of allergy to fluorescein or ICG dye.
- Medical Exclusion Criteria
- Current or history within two years of any significant heart disease.
- Uncontrolled hypertension.
Who cannot join
None listed.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
United States1 site
OXiGENE Investigational Site
Los Angeles, California
About this study
Official title: OXiGENE OXC402-201: A Phase 2, Randomized, Double-Masked, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Biological Effects of Intravenous Fosbretabulin in Asian Subjects With Polypoidal Choroidal Vasculopathy (PCV)
The primary objective of this study is to examine effects of fosbretabulin tromethamine (fosbretabulin) on PCV as reflected by a change from baseline in the number of polypoid lesions on indocyanine green angiography (ICGA).
- Conditions
- Polypoidal Choroidal Vasculopathy
- Being tested
- fosbretabulin, Saline
- Keywords
- Polypoidal Choroidal Vasculopathy, PCV, Polypoid, oxigene, VDA, vascular disrupting agent, combretastatin, fosbretabulin
- 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.
fosbretabulinDrug
Also called combretastatin, CA4P
single dose, intravenous infusion
SalineDrug
single dose, intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | single dose Receives: Drug: Saline |
| 15 mg/m^2 | Experimental | 15 mg/m^2 fosbretabulin, single dose Receives: Drug: fosbretabulin |
| 25 mg/m^2 | Experimental | 25 mg/m^2 fosbretabulin, single dose Receives: Drug: fosbretabulin |
| 35 mg/m^2 | Experimental | 35 mg/m^2 fosbretabulin, single dose Receives: Drug: fosbretabulin |
| 45 mg/m^2 | Experimental | 45 mg/m^2 fosbretabulin, single dose Receives: Drug: fosbretabulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate change in number of polypoid lesions on ICGA from baseline to Day 2
Measured: from baseline to Day 2
Evaluate change in the number of polypoid lesions on ICGA from baseline to Day 8
Measured: from baseline to Day 8
Secondary outcomes (3)
Evaluate the change in area of the branching vascular network of PCV using ICGA from baseline to Day 2
Measured: baseline to Day 2
Evaluate the change in the area of branching vascular network of PCV on ICGA from baseline to Day 8
Measured: baseline to Day 8
Examine effects of fosbretabulin on choroidal neovasculariztion (CNV) and total lesion size using fluorescein angiography (FA)
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startJul 2009
- Primary completionAug 2010
- Study completionAug 2010
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mateon Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023295
- Sponsor's protocol ID
- OXC402-201
- Status last verified
- Oct 2011
- First submitted
- 30 Nov 2009
- Last updated
- 1 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OXiGENE OXC402-201: A Phase 2, Randomized, Double-Masked, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Biological Effects of Intravenous Fosbretabulin in Asian Subjects With Polypoidal Choroidal Vasculopathy (PCV)
- ClinicalTrials.gov ID
- NCT01023295
- Acronym / sponsor ID
- OXC402-201
- Conditions
- Polypoidal Choroidal Vasculopathy
- Keywords
- Polypoidal Choroidal Vasculopathy, PCV, Polypoid, oxigene, VDA, vascular disrupting agent, combretastatin, fosbretabulin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mateon TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 2 Dec 2009 (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.
The primary objective of this study is to examine effects of fosbretabulin tromethamine (fosbretabulin) on PCV as reflected by a change from baseline in the number of polypoid lesions on indocyanine green angiography (ICGA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Salinesingle dose |
| 15 mg/m^2 | Experimental | Drug: fosbretabulin15 mg/m^2 fosbretabulin, single dose |
| 25 mg/m^2 | Experimental | Drug: fosbretabulin25 mg/m^2 fosbretabulin, single dose |
| 35 mg/m^2 | Experimental | Drug: fosbretabulin35 mg/m^2 fosbretabulin, single dose |
| 45 mg/m^2 | Experimental | Drug: fosbretabulin45 mg/m^2 fosbretabulin, single dose |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Male or female age ≥21 years.
- Asian race (e.g. Chinese, Japanese, Korean, Thai).
- Polypoidal choroidal vasculopathy in the study eye
- Presence of ≥ 1 visible polypoidal varicosity on ICGA.
- Presence of a measurable branching vascular network
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| fosbretabulinAlso: combretastatin, CA4Psingle dose, intravenous infusion | Drug | 15 mg/m^2, 25 mg/m^2, 35 mg/m^2, 45 mg/m^2 |
| Salinesingle dose, intravenous infusion | Drug | Placebo |
Primary outcome
Evaluate change in number of polypoid lesions on ICGA from baseline to Day 2
Time frame: from baseline to Day 2
Evaluate change in the number of polypoid lesions on ICGA from baseline to Day 8
Time frame: from baseline to Day 8
3 secondary outcomes
Evaluate the change in area of the branching vascular network of PCV using ICGA from baseline to Day 2
Time frame: baseline to Day 2
Evaluate the change in the area of branching vascular network of PCV on ICGA from baseline to Day 8
Time frame: baseline to Day 8
Examine effects of fosbretabulin on choroidal neovasculariztion (CNV) and total lesion size using fluorescein angiography (FA)
Time frame: Day 29
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 1 Nov 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fosbretabulin and Saline in people with Polypoidal Choroidal Vasculopathy, run by Mateon Therapeutics at 5 sites in 5 countries.
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 20 inclusion and 0 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 1 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Hong Kong, Singapore, South Korea, Taiwan. 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. Some participants in this study may receive a placebo. 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 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?
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?
Evaluate change in number of polypoid lesions on ICGA from baseline to Day 2 (time frame: from baseline to Day 2). 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 1 Nov 2011.