Observation of the Natural Course of Age-related Macular Degeneration

Dry Age-related Macular Degeneration Clinical Trial

Official title:

Observation of the Natural Course of Dry Age-related Macular Degeneration

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05418231
• Other study ID #: SXD20220609
• Status: Not yet recruiting
• Start date: July 2022
• Est. completion date: July 2027

Study information

• Verified date: June 2022
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Junran Sun, M.D.
• Phone: +8613661995933
• Email: emiliesun[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: July 2027
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Dry Age-related Macular Degeneration
• Geographic Atrophy
• Macular Degeneration
• Macular Degeneration, Dry

Locations

Country	Name	City	State
China	Shanghai General Hospital, Shanghai Jiao Tong University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity	A typical ETDRS chart that if frequently used for visual acuity testing	60 months
Secondary	Drusen density and shape	Drusen Measurement on OCT or Fundus photography	60 months
Secondary	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.	60 months
Secondary	GA growth rate		60 months