NCT05418231

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Jul 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress77%
Jul 2022Jul 2027

First Submitted

Initial submission to the registry

June 9, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 14, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Expected
Last Updated

June 14, 2022

Status Verified

June 1, 2022

Enrollment Period

2.5 years

First QC Date

June 9, 2022

Last Update Submit

June 9, 2022

Conditions

Dry Age-related Macular DegenerationMacular Degeneration, Dry

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    A typical ETDRS chart that if frequently used for visual acuity testing

    60 months

Secondary Outcomes (3)

  • Drusen density and shape

    60 months

  • The rate of 5-year progression

    60 months

  • GA growth rate

    60 months

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Dry AMD patients in Shanghai General Hospital

You may qualify if:

  • yrs male or female AMD patients
  • Dry-AMD patients in either early, intermediate, or intermediate-to-late stage confirmed by fundus examinations.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai General Hospital, Shanghai Jiao Tong University

Shanghai, 200080, China

Location

MeSH Terms

Conditions

Geographic Atrophy

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Xiaodong Sun, PHD

    Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Junran Sun, M.D.

CONTACT

+8613661995933emiliesun@sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 9, 2022

First Posted

June 14, 2022

Study Start

July 1, 2022

Primary Completion

January 1, 2025

Study Completion (Estimated)

July 1, 2027

Last Updated

June 14, 2022

Record last verified: 2022-06

Locations

CN(1)