Natural History of Geographic Atrophy Associated With Age-Related Macular Degeneration

NCT02941263 | Completed

• 2 other identifiers: 17000817-EI-0008
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Age-related macular degeneration (AMD) affects the macula in the eye. This is the central part of the retina. It is needed for sharp, clear vision and activities like reading and driving. AMD is the leading cause of vision loss in Americans 60 years of age and older. An advanced form of AMD is called geographic atrophy or GA. It happens when light-sensitive cells in the macula die so much that central vision decreases. Objective: To learn more about geographic atrophy associated with age-related macular degeneration. Eligibility: Adults at least 55 years old with a certain kind of GA. They must be enrolled in study 08-EI-0102, 08-EI-0169, 08-EI-0043, 12-EI-0042, or 11-EI-0147 but no other studies. Design: Participants will be screened with medical history, physical exam, and an eye exam. Participants will have study visits every 3 months for 15 months, then every 6 months. They will be in the study almost 4 years. Visits will last about 8 hours. At each visit, participants may have:

• Medical and eye history. Participants will answer questions about their general health and eye health. They may answer written questions about how their eye problems affect their life.
• Eye exam and photographs. Eye pressure will be measured and eye movements will be checked. Pupils will be dilated with drops. The thickness of the retina will be measured and photos of the eye may be taken....

Conditions

Age-Related Macular Degeneration

Keywords

Eye Disease; Natural History

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the difference in the mean rate of change in area of GA in the study eye based on digital grading of FAF images by an external Reading Center.

  Difference in the mean rate of change in area of GA in the study eye based on digital grading of FAF images by an external Reading Center.

  Calculated 45 months as compared to baseline

Secondary Outcomes (1)

• Differences in study eyes for the following: mean rate of change in area of GA based on digital grading of color fundus images, mean changes in BCVA, mean changes in central retinal thickness on OCT, and the proportion of study eyes developing w...

  45 months as compared to baseline

Study Arms (1)

Affected Participants

Participants with unilateral or bilateral GA associated with atrophic AMD.

Eligibility Criteria

• Age: 55 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Twenty-five (25) participants, age 55 years and older, with unilateral or bilateral GA associated with atrophic AMD will be accrued.

You may qualify if:

• Participant must be 55 years of age or older.
• Participant must understand and sign the protocol s informed consent document.
• Participant must have evidence of early or intermediate AMD as defined by characteristic presence of drusen and/or pigmentary changes.
• Participant is enrolled in one of the following screening protocols: 08-EI-0102, 08-EI-0169 (closed), 08-EI-0043, 12-EI-0042, 11-EI-0147, or 16-EI-0134.

You may not qualify if:

• Participant is actively receiving study therapy in another investigational study.
• Participant is unable to comply with study procedures or follow-up visits.
• Participant is on ocular or systemic medications known to be toxic to the lens, retina or optic nerve (e.g., ethambutol, chloroquine, or hydroxychloroquine).
• STUDY EYE ELIGIBILITY CRITERIA:
• The study eye(s) must have GA compatible with dry AMD. GA is defined as one or more well-defined and often circular patches of partial or complete depigmentation of the RPE, typically with exposure of underlying choroidal blood vessels. Even if much of the RPE appears to be preserved and large choroidal vessels are not visible, a round patch of RPE partial depigmentation may be classified as early GA. The GA in the study eye must be able to be photographed in their entirety and it must not be contiguous with any areas of peripapillary atrophy, which can complicate area measurements.
• The study eye(s) must have clarity of ocular media and degree of pupil dilation sufficient to permit adequate fundus photographs.
• Current evidence of neovascularization as determined by the treating physician or a history of treatments for neovascularization.
• Evidence of retinal atrophy due to causes other than atrophic AMD.
• Current evidence or history of ocular disorders in the study eye that might confound study outcome measures, including (but not limited to):
• non-proliferative diabetic retinopathy involving 10 or more hemorrhages or microaneurysms, or active proliferative diabetic retinopathy
• Branch or central retinal vein or artery occlusion
• Macular hole
• Pathologic myopia
• Uveitis
• Pseudovitelliform maculopathy

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Macular Degeneration; Eye Diseases

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases

Study Officials

• Tiarnan DL Keenan, M.D.

  National Eye Institute (NEI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: October 21, 2016
• Study Start: March 8, 2017
• Primary Completion: May 22, 2024
• Study Completion: May 22, 2024
• Last Updated: June 5, 2026

Record last verified: 2026-02-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)