Observation of the Natural Course of Age-related Macular... | NCT05418231

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

NCT05418231

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Status

Not yet recruiting

Last Update Posted

Jun 14, 2022Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Dry Age-related Macular Degeneration
Macular Degeneration, Dry

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2022Estimated

Primary Completion Date

Jan 2025Estimated

Completion Date

Jul 2027Estimated

First Submitted Date

Jun 9, 2022

First Submission Date that Met QC Criteria

Jun 9, 2022

First Posted Date

Jun 14, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2022

Last Update Posted Date

Jun 14, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiaodong Sun, Professor, Shanghai General Hospital, Shanghai Jiao Tong University School of MedicinePrincipal Investigator

Lead Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Dry AMD patients in Shanghai General Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Junran Sun, M.D.	Contact	+8613661995933		emiliesun@sina.com

Overall Officials

Name	Affiliation	Role
Xiaodong Sun, PHD	Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai General Hospital, Shanghai Jiao Tong University		Shanghai		200080	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D057092	Geographic Atrophy

Ancestor Terms

ID	Term
D008268	Macular Degeneration
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided