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NCT Number: NCT05418231

Observation of the Natural Course of 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.

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Key information

Conditions

Dry Age-related Macular Degeneration Eye Diseases Geographic Atrophy Macular Degeneration Macular Degeneration, Dry Retinal Degeneration Retinal Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai General Hospital, Shanghai Jiao Tong University

Shanghai, 200080, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Visual acuity

    Time frame: 60 months

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

Secondary outcomes

  1. Drusen density and shape

    Time frame: 60 months

    Drusen Measurement on OCT or Fundus photography

  2. The rate of 5-year progression

    Time frame: 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.

  3. GA growth rate

    Time frame: 60 months

Study contacts

Contact information is provided by the study sponsor or research team.

Junran Sun, M.D.

CONTACT

[email protected]

+8613661995933

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Jun 14, 2022
Registry last updated
Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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