Observation of the Natural Course of Age-related Macular Degeneration

Not yet recruiting

• Conditions: Dry Age-related Macular Degeneration; Macular Degeneration, Dry

• Registration Number: NCT05418231
• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-09
• Study First Submitted QC: 2022-06-09
• Last Update Submitted: 2022-06-09
• Study First Posted: 2022-06-14
• Last Update Posted: 2022-06-14
• Study Start: 2022-07
• Primary Completion: 2025-01
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual acuity	60 months	A typical ETDRS chart that if frequently used for visual acuity testing

Secondary Outcome Measures

Name	Time	Method
The rate of 5-year progression	60 months	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.
Drusen density and shape	60 months	Drusen Measurement on OCT or Fundus photography
GA growth rate	60 months

Trial Locations

Locations (1)

Shanghai General Hospital, Shanghai Jiao Tong University; 🇨🇳 Shanghai, China