Observation of the Natural Course of Age-related Macular Degeneration

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dry Age-related Macular Degeneration; Macular Degeneration, Dry

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Junran Sun, M.D.; Phone Number: +8613661995933; Email: emiliesun@sina.com

Study Locations

• China
  • Shanghai, China, 200080
    • Shanghai General Hospital, Shanghai Jiao Tong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Dry AMD patients in Shanghai General Hospital

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	A typical ETDRS chart that if frequently used for visual acuity testing	60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drusen density and shape	Drusen Measurement on OCT or Fundus photography	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.	60 months
GA growth rate		60 months

Collaborators and Investigators

• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2022
• Primary Completion (ANTICIPATED): January 1, 2025
• Study Completion (ANTICIPATED): July 1, 2027

Study Registration Dates

• First Submitted: June 9, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (ACTUAL): June 14, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Geographic Atrophy
• Other Study ID Numbers: SXD20220609

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No