Dry Age-related Macular DegenerationNCT05418231
Observation of the Natural Course of Age-related Macular Degeneration
An observational study of Dry Age-related Macular Degeneration and Macular Degeneration, Dry, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This research will study natural course of dry AMD in Chinese population, screen fundus imaging indicators for patients with Chinese dry AMD, describe the clinical features of Chinese patients with dry AMD, and obtain a biological sample library of dry AMD mainly in China. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Dry Age-related Macular Degeneration, Macular Degeneration, Dry
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Jul 2022to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Dry AMD patients in Shanghai General Hospital
Who may be able to join
- 50-85 yrs male or female AMD patients
- Dry-AMD patients in either early, intermediate, or intermediate-to-late stage confirmed by fundus examinations.
Who cannot join
- Any eye with disease that would interfere with the retinal examinations
- Research eye with CNV or high myopia
- Surgeries that may interfere with AMD evaluation
- Long-term uses of medications that are associated with retinal or neural toxicities.
- IOP more than 26 mmHg
- Received cataract surgery in 3 months.
- Other conditions: diseases that causes less than 5 years survival; any condition that causes high risk of drop-out, or low compliance, for instance cognition disorder; have been involved in other trial that interfere with the current visit plan; taking other angiogenesis Inhibitors drugs for treating cancer.
- Other conditions not suitable for the current study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai General Hospital, Shanghai Jiao Tong University
Shanghai, 200080
About this study
Official title: Observation of the Natural Course of Dry Age-related Macular Degeneration
This research will study natural course of dry AMD in Chinese population, screen fundus imaging indicators for patients with Chinese dry AMD, describe the clinical features of Chinese patients with dry AMD, and obtain a biological sample library of dry AMD mainly in China.
- Medical subject headings
- Geographic Atrophy
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
A typical ETDRS chart that if frequently used for visual acuity testing
Measured: 60 months
Secondary outcomes (3)
Drusen density and shape
Drusen Measurement on OCT or Fundus photography
Measured: 60 months
The rate of 5-year progression
The evaluation criteria for progression: progress to intermediate (only for patients with early phase AMD at baseline) or intermediate-to-late, or late stage AMD.
Measured: 60 months
GA growth rate
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study startJul 2022 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaodong Sun, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Xiaodong Sun, PHD, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418231
- Sponsor's protocol ID
- SXD20220609
- Status last verified
- Jun 2022
- First submitted
- 9 Jun 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of the Natural Course of Dry Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT05418231
- Acronym / sponsor ID
- SXD20220609
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 14 Jun 2022 (actual)
- 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.
This research will study natural course of dry AMD in Chinese population, screen fundus imaging indicators for patients with Chinese dry AMD, describe the clinical features of Chinese patients with dry AMD, and obtain a biological sample library of dry AMD mainly in China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Dry AMD patients in Shanghai General Hospital
Key inclusion criteria (2 listed)
- 50-85 yrs male or female AMD patients
- Dry-AMD patients in either early, intermediate, or intermediate-to-late stage confirmed by fundus examinations.
Key exclusion criteria (8 listed)
- Any eye with disease that would interfere with the retinal examinations
- Research eye with CNV or high myopia
- Surgeries that may interfere with AMD evaluation
- Long-term uses of medications that are associated with retinal or neural toxicities.
- IOP more than 26 mmHg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual acuity
Time frame: 60 months
A typical ETDRS chart that if frequently used for visual acuity testing
3 secondary outcomes
Drusen density and shape
Time frame: 60 months
The rate of 5-year progression
Time frame: 60 months
GA growth rate
Time frame: 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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.
Xiaodong Sun, PHD principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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 Dry Age-related Macular Degeneration and Macular Degeneration, Dry, run by Shanghai General Hospital, Shanghai Jiao Tong University School of 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 2 inclusion and 8 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: opening soon, as of the sponsor's last update on 14 Jun 2022. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junran Sun, M.D. (+8613661995933, emiliesun@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: 60 months). 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 14 Jun 2022.