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

NCT ID: NCT02941263

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-08
• Study Completion Date: 2024-05-22

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.

Detailed Description

Objective: Age-related macular degeneration (AMD), the leading cause of blindness in people over age 65 in the United States, is a heterogeneous clinical entity in which retinal degeneration occurs predominantly in the macula in the context of aging and leads to impairment of central visual acuity (VA). AMD occurs in two general forms, one of which involves choroidal neovascularization (CNV) with subsequent formation of a disciform scar. This is often referred to as the neovascular or wet form. A second form, the subject of this study, is termed dry atrophic macular degeneration or otherwise geographic atrophy (GA) and involves a slow progressive atrophy of retinal pigment epithelial (RPE) cells and photoreceptors in the macula, also resulting in central vision loss. GA is estimated to affect up to one million people in the U.S. and there is no current treatment that can prevent its onset. While the etiology of GA is not completely understood, inflammatory processes involving the activation of resident immune cells of the retina called microglia are likely to contribute. The objective of this study is to study the progression of GA so as to be able to characterize in quantitative terms the natural progression of GA in patients, whether or not they are receiving any directed treatment.

Study Population: Twenty-five (25) participants with unilateral or bilateral GA associated with AMD will be enrolled.

Design: This prospective, natural history study will follow participants with GA associated with AMD.

Outcome Measures:

The primary outcome is the rate of change in area of GA based on grading by an external Reading Center of fundus autofluorescence (FAF) images in the assigned study eye. The primary outcome will be calculated for 45 months as compared to baseline.

Secondary outcomes will include changes in best-corrected visual acuity (BCVA), rate of change in area of GA based on fundus photography and development of exudative AMD ascertained using optical coherence tomography (OCT) and changes in macular sensitivity.

Conditions

Age-Related Macular Degeneration

Keywords

Eye Disease; Natural History

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Affected Participants

Participants with unilateral or bilateral GA associated with atrophic AMD.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Participant must be 55 years of age or older.

2. Participant must understand and sign the protocol s informed consent document.

3. Participant must have evidence of early or intermediate AMD as defined by characteristic presence of drusen and/or pigmentary changes.

4. 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.

1. 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.

2. The study eye(s) must have clarity of ocular media and degree of pupil dilation sufficient to permit adequate fundus photographs.

Exclusion Criteria

1. Participant is actively receiving study therapy in another investigational study.

2. Participant is unable to comply with study procedures or follow-up visits.

3. 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:

1. Current evidence of neovascularization as determined by the treating physician or a history of treatments for neovascularization.

2. Evidence of retinal atrophy due to causes other than atrophic AMD.

3. Current evidence or history of ocular disorders in the study eye that might confound study outcome measures, including (but not limited to):

1. non-proliferative diabetic retinopathy involving 10 or more hemorrhages or microaneurysms, or active proliferative diabetic retinopathy

2. Branch or central retinal vein or artery occlusion

3. Macular hole

4. Pathologic myopia

5. Uveitis

6. Pseudovitelliform maculopathy

4. History of vitreoretinal surgery.

5. Need for ocular surgery during the course of the study.

6. Recent history of lens removal (< 3 months prior to enrollment) or Yttrium Aluminum Garnet (YAG) laser capsulotomy (< 1 month prior to enrollment).

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Eye Institute (NEI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tiarnan DL Keenan, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Eye Institute (NEI)

Locations

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Countries

United States

Related Links

https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2017-EI-0008.html

NIH Clinical Center Detailed Web Page

Other Identifiers

17-EI-0008

Identifier Type: -

Identifier Source: secondary_id

170008

Identifier Type: -

Identifier Source: org_study_id