Age-Related Macular DegenerationPhase 1NCT00725686
Study of PF-04523655 (REDD14NP) In Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (Wet AMD)
A Phase 1 study testing PF-04523655 in people with Age-Related Macular Degeneration, run by Quark Pharmaceuticals at 11 sites in 2 countries.
Trial summary
The aim of the study is to evaluate whether PF-04523655 is safe in the treatment of neovascular/wet AMD Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- PF-04523655
- How many people
- 54 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Feb 2007to Nov 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is ≥ 50 years old and in general good health. Patients with medically controlled chronic disease such as HTN, AODM, and hyperlipidemia may be included.
- Patient is capable of giving consent.
- Patient is willing and able to comply with the visit schedule and study procedures including follow-up visits.
- Patient has documented CNV secondary to AMD with evidence of active disease characterized by blood vessel leakage or evidence of hemorrhage.
- Patient has clear ocular media and adequate pupil dilation to allow good quality imaging by fundus photography.
- Patient's intraocular pressure is ≤ 25 mmHg
Who cannot join
- Patient is of childbearing potential. Every female patient is considered of child-bearing potential unless she has had sterilization surgery or is post-menopausal and has not had a menstrual period for at least 12 months.
- Patient has CNV due to causes other than AMD, including ocular or periocular infections.
- Patient has lesions not easily imaged and quantified.
- Patient has underlying systemic disease such as cardiac, neurological, infectious disease, uncontrolled diabetes mellitis, or disease of the eye other than AMD. Patient may have medically controlled glaucoma.
- Patient is participating in any concurrent interventional study.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States8 sites
Pfizer Investigational Site
‘Aiea, Hawaii, 96701
Pfizer Investigational Site
Baltimore, Maryland, 21205
Pfizer Investigational Site
Beverly Hills, California, 90211
Pfizer Investigational Site
Cleveland, Ohio, 44195
Pfizer Investigational Site
Miami, Florida, 33136
Pfizer Investigational Site
New York, New York, 10022
Pfizer Investigational Site
Pasadena, California, 91105
Pfizer Investigational Site
Walnut Creek, California, 94598
Israel3 sites
Pfizer Investigational Site
Petah Tikva, 49100
Pfizer Investigational Site
Rehovot, 76100
Pfizer Investigational Site
Tel Aviv, Israel, 64239
About this study
Official title: A Phase I Open-Label, Dose Escalation Trial Of REDD14NP Delivered By A Single Intravitreal Injection To Patients With Choroidal Neovascularization (CNV) Secondary To Exudative Age-Related Macular Degeneration ("Wet AMD").
The aim of the study is to evaluate whether PF-04523655 is safe in the treatment of neovascular/wet AMD
Read the detailed description
Dose escalation safety study
- Conditions
- Age-Related Macular Degeneration
- Being tested
- PF-04523655
- Keywords
- Choroidal Neovascularization (CNV) "WET" AMD
- Medical subject headings
- Macular Degeneration, Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04523655Drug
Also called REDD14NP
This is a dose-escalation study (50, 100, 200, 400, 670, 1000, 1500, 2250, 3000 microgram) given at baseline and then the subject is followed up for 24 months
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and tolerability of PF-04523655 when administered as a single intravitreal injection
Measured: Over a 24-Month Period
Secondary outcomes (4)
To describe anatomical changes in the retina and choroid following the administration of PF-04523655
Measured: Day 14
To determine the changes in visual acuity ETDRS chart after a single intravitreal injection of PF-04523655
Measured: Day 14
To evaluate the safety, efficacy and frequency of dosing following administration of PF-04523655 of approved VEGF-inhibitors in those study patients requiring rescue therapy
Measured: Monthly
To evaluate early response after a single intravitreal administration of PF-04523655 in patients who, in the opinion of the investigator, have the potential to show improvement in visual acuity from other treatment options (Stratum 2 patients)
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startFeb 2007
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quark Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725686
- Sponsor's protocol ID
- B0451008
- Other IDs
- QRK.003
- Status last verified
- Oct 2012
- First submitted
- 28 Jul 2008
- Last updated
- 10 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-Label, Dose Escalation Trial Of REDD14NP Delivered By A Single Intravitreal Injection To Patients With Choroidal Neovascularization (CNV) Secondary To Exudative Age-Related Macular Degeneration ("Wet AMD").
- ClinicalTrials.gov ID
- NCT00725686
- Acronym / sponsor ID
- B0451008
- Conditions
- Age-Related Macular Degeneration
- Keywords
- Choroidal Neovascularization (CNV) "WET" AMD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Quark PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Feb 2007
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 30 Jul 2008 (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 aim of the study is to evaluate whether PF-04523655 is safe in the treatment of neovascular/wet AMD
Detailed description
Dose escalation safety study
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is ≥ 50 years old and in general good health. Patients with medically controlled chronic disease such as HTN, AODM, and hyperlipidemia may be included.
- Patient is capable of giving consent.
- Patient is willing and able to comply with the visit schedule and study procedures including follow-up visits.
- Patient has documented CNV secondary to AMD with evidence of active disease characterized by blood vessel leakage or evidence of hemorrhage.
- Patient has clear ocular media and adequate pupil dilation to allow good quality imaging by fundus photography.
Key exclusion criteria (5 listed)
- Patient is of childbearing potential. Every female patient is considered of child-bearing potential unless she has had sterilization surgery or is post-menopausal and has not had a menstrual period for at least 12 months.
- Patient has CNV due to causes other than AMD, including ocular or periocular infections.
- Patient has lesions not easily imaged and quantified.
- Patient has underlying systemic disease such as cardiac, neurological, infectious disease, uncontrolled diabetes mellitis, or disease of the eye other than AMD. Patient may have medically controlled glaucoma.
- Patient is participating in any concurrent interventional study.
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 |
|---|---|---|
| PF-04523655Also: REDD14NPThis is a dose-escalation study (50, 100, 200, 400, 670, 1000, 1500, 2250, 3000 microgram) given at baseline and then the subject is followed up for 24 months | Drug | – |
Primary outcome
To determine the safety and tolerability of PF-04523655 when administered as a single intravitreal injection
Time frame: Over a 24-Month Period
4 secondary outcomes
To describe anatomical changes in the retina and choroid following the administration of PF-04523655
Time frame: Day 14
To determine the changes in visual acuity ETDRS chart after a single intravitreal injection of PF-04523655
Time frame: Day 14
To evaluate the safety, efficacy and frequency of dosing following administration of PF-04523655 of approved VEGF-inhibitors in those study patients requiring rescue therapy
Time frame: Monthly
To evaluate early response after a single intravitreal administration of PF-04523655 in patients who, in the opinion of the investigator, have the potential to show improvement in visual acuity from other treatment options (Stratum 2 patients)
Time frame: Day 14
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 10 Oct 2012.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-04523655 in people with Age-Related Macular Degeneration, run by Quark Pharmaceuticals at 11 sites in 2 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 6 inclusion and 5 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 10 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Israel. 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?
To determine the safety and tolerability of PF-04523655 when administered as a single intravitreal injection (time frame: Over a 24-Month Period). 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 10 Oct 2012.