Geographic AtrophyNCT01666821
A Population-based Study of Macular Choroidal Neovascularization in a Chinese Population
An observational study of Geographic Atrophy and Wet Macular Degeneration, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
To investigate pathomorphological and functional variations of choroidal neovascularization (CNV) in age-related macular degeneration (AMD) in a Chinese population using optical coherence tomography (OCT) to find which kinds of Fundus characteristics indicated exudative AMD. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Geographic Atrophy, Wet Macular Degeneration, Retinal Drusen
- What is being tested?
- Follow-up observation
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- May 2004to Jan 2009
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: recruited 1813 adults citizens aged above 45 years by probability sampling from the Youyi Street, Baoshan District, Shanghai, China for an epidemiologic survey. All participants gave written informed consent, and this study was approved by the local Ethics Committee in accordance with the Helsinki Declaration.
Who may be able to join
- adults citizens aged above 45 years
Who cannot join
- lost samples
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Population-based Study of Macular Choroidal Neovascularization Using Optical Coherence Tomography in a Chinese Population
To investigate pathomorphological and functional variations of choroidal neovascularization (CNV) in age-related macular degeneration (AMD) in a Chinese population using optical coherence tomography (OCT) to find which kinds of Fundus characteristics indicated exudative AMD.
Read the detailed description
This population-based study enrolled 59 patients (>45 years old; 70 eyes) with early and intermediate-stage AMD from Youyi Street, Baoshan District, Shanghai, China. Comprehensive standardized ophthalmic examinations included visual acuity, anterior segment analysis by slit lamp, dilated fundus evaluation by direct ophthalmoscopy, 90D handheld lens, fundus photography, fluorescein angiography (FFA), and fast optic disk scans using OCT. The macular CNV characteristic profiles in early and intermediate-stage AMD were determined by OCT. Data were obtained at first visit and 6 to 24 months follow-up, and FFA and OCT outcomes of early and intermediate-stage AMD patients were analyzed.
- Conditions
- Geographic Atrophy, Wet Macular Degeneration, Retinal Drusen
- Being tested
- Follow-up observation
- Keywords
- macular degeneration; choroidal neovascularization
- Medical subject headings
- Geographic Atrophy, Wet Macular Degeneration, Retinal Drusen, Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up observationOther
a epidemiologic survey of ocular diseases in an adult population (>45 years old) in Youyi Street, Baoshan District, Shanghai, China, conducted to determine the prevalence of AMD in the region. To this end, we utilized routine ocular examinations
| Study group | Role | What they receive |
|---|---|---|
| early and intermediate-stage AMD | Follow-up observation was implemented in whose fundus examination show lesions in the early and intermediate-stage AMD Receives: Other: Follow-up observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of the early and intermediate-stage AMD
Drusen with unclear boundaries and obvious pigment proliferation, with hypofluorescence around drusens seen on FFA and a slight small arch field located in the retinal pigment epithelium (RPE)/choriocapillary layer (CCL) on OCT indicated exudative AMD.
Measured: May 2004-September 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startMay 2004
- Primary completionSep 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geographic AtrophyStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Hu, Shanghai University of Traditional Chinese Medicine
- Investigators
- zhao jie, master, Principal investigator, Director of ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666821
- Sponsor's protocol ID
- 04-E-1
- Status last verified
- Aug 2012
- First submitted
- 14 Aug 2012
- Last updated
- 16 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Population-based Study of Macular Choroidal Neovascularization Using Optical Coherence Tomography in a Chinese Population
- ClinicalTrials.gov ID
- NCT01666821
- Acronym / sponsor ID
- 04-E-1
- Conditions
- Geographic Atrophy, Wet Macular Degeneration, Retinal Drusen
- Keywords
- macular degeneration; choroidal neovascularization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- Sep 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 16 Aug 2012 (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.
To investigate pathomorphological and functional variations of choroidal neovascularization (CNV) in age-related macular degeneration (AMD) in a Chinese population using optical coherence tomography (OCT) to find which kinds of Fundus characteristics indicated exudative AMD.
Detailed description
This population-based study enrolled 59 patients (>45 years old; 70 eyes) with early and intermediate-stage AMD from Youyi Street, Baoshan District, Shanghai, China. Comprehensive standardized ophthalmic examinations included visual acuity, anterior segment analysis by slit lamp, dilated fundus evaluation by direct ophthalmoscopy, 90D handheld lens, fundus photography, fluorescein angiography (FFA), and fast optic disk scans using OCT. The macular CNV characteristic profiles in early and intermediate-stage AMD were determined by OCT. Data were obtained at first visit and 6 to 24 months follow-up, and FFA and OCT outcomes of early and intermediate-stage AMD patients were analyzed.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| early and intermediate-stage AMD | – | Other: Follow-up observationFollow-up observation was implemented in whose fundus examination show lesions in the early and intermediate-stage AMD |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- recruited 1813 adults citizens aged above 45 years by probability sampling from the Youyi Street, Baoshan District, Shanghai, China for an epidemiologic survey. All participants gave written informed consent, and this study was approved by the local Ethics Committee in accordance with the Helsinki Declaration.
Key inclusion criteria (1 listed)
- adults citizens aged above 45 years
Key exclusion criteria (1 listed)
- lost samples
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 |
|---|---|---|
| Follow-up observationa epidemiologic survey of ocular diseases in an adult population (>45 years old) in Youyi Street, Baoshan District, Shanghai, China, conducted to determine the prevalence of AMD in the region. To this end, we utilized routine ocular examinations | Other | early and intermediate-stage AMD |
Primary outcome
change of the early and intermediate-stage AMD
Time frame: May 2004-September 2008
Drusen with unclear boundaries and obvious pigment proliferation, with hypofluorescence around drusens seen on FFA and a slight small arch field located in the retinal pigment epithelium (RPE)/choriocapillary layer (CCL) on OCT indicated exudative AMD.
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 16 Aug 2012.
Related trials for Geographic Atrophy
Active, not recruitingPhase 1/2
Phase 1/2 Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Age-Related Macular Degeneration, Geographic Atrophy
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingPhase 3
A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
Age-related Macular Degeneration (AMD), Geographic Atrophy (GA)
RecruitingPhase 1
Phase 1 Study of C.001 in Retinal Degeneration
Geographic Atrophy, Stargardt Disease
RecruitingPhase 2/3
A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Geographic Atrophy, 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.
zhao jie, master principal investigator
Director of ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Geographic Atrophy and Wet Macular Degeneration, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
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 1 inclusion and 1 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 Aug 2012. 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 China. 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 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?
change of the early and intermediate-stage AMD (time frame: May 2004-September 2008). 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 16 Aug 2012.