Not yet recruiting NCT05418231
Observation of the Natural Course of Age-related Macular Degeneration
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Dry Age-related Macular Degeneration, Macular Degeneration, Dry. Basic parameters: 50 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Observation of the Natural Course of Dry Age-related Macular Degeneration
Overview
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.
Primary outcome measures
- Visual acuity [Time frame: 60 months]
Secondary outcome measures (3)
- 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]
Eligibility criteria
Inclusion criteria
- 50-85 yrs male or female AMD patients
- Dry-AMD patients in either early, intermediate, or intermediate-to-late stage confirmed by fundus examinations.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Shanghai General Hospital, Shanghai Jiao Tong University — Shanghai
Identifiers
NCT: NCT05418231 · SXD20220609