Eye disease study tracks vision loss over years
NCT ID NCT02941263
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 11 times
Summary
This study followed 20 adults aged 55 and older with geographic atrophy, an advanced form of age-related macular degeneration that causes central vision loss. Researchers measured how the damaged area in the eye changed over nearly 4 years using eye exams and photos. The goal was to better understand the natural course of the disease, not to test a treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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20 people
The number who actually took part.
- Started
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Mar 2017
- Finished
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May 2024
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Twenty-five (25) participants, age 55 years and older, with unilateral or bilateral GA associated with atrophic AMD will be accrued.
- Ages
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55 to 120 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: To be eligible, the following inclusion criteria must be met, where applicable. 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. EXCLUSION CRITERIA: A participant is not eligible if any of the following exclusion criteria are present. 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: The participant must have at least one eye meeting all inclusion criteria and none of the exclusion criteria listed below. STUDY EYE INCLUSION CRITERIA: 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. STUDY EYE EXCLUSION 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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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