Choroidal Neovascularization (CNV)NCT00902785
A Study Of Early Markers Of Choroidal Neovascularization
An observational study of Choroidal Neovascularization (CNV) and Age-related Macular Degeneration (AMD), run by Pfizer at 3 sites in 3 countries.
Trial summary
Identify early markers of choroidal neovascularization (CNV) in the fellow eye of a patient with CNV in the other eye due to age-related macular degeneration with the expectation of being able to identify patients in need of intervention. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Choroidal Neovascularization (CNV), Age-related Macular Degeneration (AMD), Early Markers
- What is being tested?
- no drug
- How many people
- 100 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Mar 2008to May 2010
- Phase
- Observational
- 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
Study population: * age-related macular degeneration (AMD) * choroidal neovascularization (CNV)
Who may be able to join
- Sub-, extra- or juxta-foveal choroidal neovascularization (CNV) or macular scar due to AMD in the non-study eye.
- No CNV or geographic atrophy in the study eye.
- Best corrected visual acuity in the study eye of greater than 20/40 or better than 70 ETDRS letters.
- Sufficiently clear ocular media and adequate pupillary dilatation to permit good quality fundus imaging of the study eye.
- Subjects of either sex, aged 50 years.
- Evidence of a signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
- Willing and able to comply with scheduled visits, laboratory tests, and other trial procedures.
Who cannot join
- Subjects presenting with any of the following will not be included in the study:
- Evidence of manifest CNV by FA, color photography or ICG angiography in the study eye.
- Any prior treatment for CNV to the study eye (excluding vitamins and AREDS formula).
- Significant media opacities, including cataract, which might interfere with visual acuity assessments, or fundus imaging in the study eye. Subjects should not be entered if there is likelihood that they will require cataract surgery within the following 2 years.
- Presence of other causes of choroidal neovascularization in the fellow eye, including pathologic myopia (spherical equivalent of -8 diopters or more negative, or axial length of 25 mm or more), the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis.
- Any progressive eye disease other than AMD (eg, glaucoma, diabetic retinopathy) in the study eye.
Show all 11Show fewer
- Presence of subretinal hemorrhage, serous or hemorrhagic pigment epithelial detachments, subretinal fibrosis or pigment epithelial tears or rips in the study eye.
- Any medical condition that would interfere with the patient's ability to complete the trial.
- Concurrent enrollment in any other observational or interventional clinical study.
- Any treatment with an ocular or systemic investigational agent in the past 60 days for any medical condition.
- Known serious allergies to the dye used in fluorescein angiography or ICG.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Two-Year Exploratory, Observational, Non-Interventional Multicenter Study To Identify Early Markers Of Choroidal Neovascularization In Fellow Eyes Of Patients With Neovascular AMD In One Eye
Identify early markers of choroidal neovascularization (CNV) in the fellow eye of a patient with CNV in the other eye due to age-related macular degeneration with the expectation of being able to identify patients in need of intervention.
Read the detailed description
CNV in one eye and dry AMD in the other
- Being tested
- no drug
- Keywords
- exploratory, observational, non-interventional study age-related macular degeneration (AMD) choroidal neovascularization (CNV)
- Medical subject headings
- Choroidal Neovascularization, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no drugOther
observational no drug
| Study group | Role | What they receive |
|---|---|---|
| no drug | no drug Receives: Other: no drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify the sequence of change in the chorioretinal interface during the development of CNV and the progression from dry to neovascular AMD.
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 posted15 May 2009 (estimated)
- Study startMar 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choroidal Neovascularization (CNV)Studies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902785
- Sponsor's protocol ID
- A9011051
- Status last verified
- Nov 2010
- First submitted
- 13 May 2009
- Last updated
- 10 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Year Exploratory, Observational, Non-Interventional Multicenter Study To Identify Early Markers Of Choroidal Neovascularization In Fellow Eyes Of Patients With Neovascular AMD In One Eye
- ClinicalTrials.gov ID
- NCT00902785
- Acronym / sponsor ID
- A9011051
- Keywords
- exploratory, observational, non-interventional study age-related macular degeneration (AMD) choroidal neovascularization (CNV)
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 15 May 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.
Identify early markers of choroidal neovascularization (CNV) in the fellow eye of a patient with CNV in the other eye due to age-related macular degeneration with the expectation of being able to identify patients in need of intervention.
Detailed description
CNV in one eye and dry AMD in the other
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no drug | – | Other: no drugno drug |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * age-related macular degeneration (AMD) * choroidal neovascularization (CNV)
Key inclusion criteria (7 listed)
- Sub-, extra- or juxta-foveal choroidal neovascularization (CNV) or macular scar due to AMD in the non-study eye.
- No CNV or geographic atrophy in the study eye.
- Best corrected visual acuity in the study eye of greater than 20/40 or better than 70 ETDRS letters.
- Sufficiently clear ocular media and adequate pupillary dilatation to permit good quality fundus imaging of the study eye.
- Subjects of either sex, aged 50 years.
Key exclusion criteria (11 listed)
- Subjects presenting with any of the following will not be included in the study:
- Evidence of manifest CNV by FA, color photography or ICG angiography in the study eye.
- Any prior treatment for CNV to the study eye (excluding vitamins and AREDS formula).
- Significant media opacities, including cataract, which might interfere with visual acuity assessments, or fundus imaging in the study eye. Subjects should not be entered if there is likelihood that they will require cataract surgery within the following 2 years.
- Presence of other causes of choroidal neovascularization in the fellow eye, including pathologic myopia (spherical equivalent of -8 diopters or more negative, or axial length of 25 mm or more), the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis.
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 |
|---|---|---|
| no drugobservational no drug | Other | no drug |
Primary outcome
Identify the sequence of change in the chorioretinal interface during the development of CNV and the progression from dry to neovascular AMD.
Time frame: 2 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2010.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Choroidal Neovascularization (CNV)
Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration
Neovascular Age Related Macular Degeneration(nAMD)
Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Neovascular Age-related Macular Degeneration
RecruitingPhase 2/3
A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002)
Macular Degeneration, Age-Related Macular Degeneration
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
Active, not recruitingPhase 1/2
NG101 AAV Gene Therapy in Subjects With Wet Age-Related Macular Degeneration
Age-Related Macular Degeneration
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
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Choroidal Neovascularization (CNV) and Age-related Macular Degeneration (AMD), run by Pfizer at 3 sites in 3 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 7 inclusion and 11 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: stopped early, as of the sponsor's last update on 10 Nov 2010. 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 Italy, Portugal, United Kingdom. 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.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Identify the sequence of change in the chorioretinal interface during the development of CNV and the progression from dry to neovascular AMD. (time frame: 2 years). 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 Nov 2010.