Dark Adaptation in Participants With Age-Related Macular Degeneration

NCT03225131 | Completed

• 2 other identifiers: 17011217-EI-0112
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Macular degeneration can cause permanent loss of central vision. This vision is important for seeing details. Age-related macular degeneration (AMD) is the leading cause of vision loss in people over 55 in the United States. Researchers want to follow people with AMD to study the early to middle stages of the disease. Objective: To follow for another 5 years participants who completed NIH study 11-EI-0147. Eligibility: Participant was enrolled in and completed study 11-EI-0147. Design: Participants will have at least 6 study visits over 5 years. Each visit takes about 5 hours. At visit 1, participants will be asked about their medical and eye disease history. They will have an eye exam. The exam will test vision, eye pressure, and eye movements. The pupil will be dilated with eye drops. Participants will have baseline exams. These include a health history and questions about problems that affect their eyes under different lighting. They will answer these questions each year. At each visit, participants will have some or all of these tests: Eye exam Dark adaptation protocol. This measures how fast the eyes recover when exposed to decreasing levels of light. The pupil will be dilated with eye drops. Participants will sit in front of a metal box with a camera inside. They will push a button when they see a light in the machine. View a bright background light for 5 minutes. After the light is turned off participants will push a button when a blue or red light is seen. Sit in the dark for about 30 minutes. Participants will push a button when they see a blue or red light.

Conditions

Age-Related Macular Degeneration

Keywords

Age Related Macular Degeneration; Dark Adaptation; Natural History

Outcome Measures

Primary Outcomes (1)

• The primary objective will be to determine mean change, including distribution of change in dark adaptation response between baseline and months 12, 24 and 48 in participants with varying degree of severity of AMD.

  The primary objective will be to determine mean change, including distribution of change in dark adaptation response between baseline and months 12, 24 and 48 in participants with varying degree of severity of AMD (Groups 0, 1, 2, 3 and 4).

  Months 12 and 24 and 48

Secondary Outcomes (1)

• Mean change in dark adaptation and other characteristic parameters of the dark adaptation response from baseline at months 12, 24, 36, 48 and 60, and mean best-corrected visual acuity (BCVA) of the study eye from baseline and months 12, 24, 36, ...

  Months 12, 24, 36, 48 and 60

Study Arms (5)

0

participants without AMD meaning no large drusen (= 125 microns) or advanced AMD in either eye

1

participants with large drusen (= 125 microns) in the study eye and no large drusen or advanced AMD (choroidal neovascularization (CNV) or geographic atrophy (GA)) in the fellow eye

2

participants with bilateral large drusen (= 125 microns) with or without retinal pigment epithelial hypo/hyperpigmentary changes

3

participants with large drusen (= 125 microns) in the study eye and advanced AMD (CNV or GA) in the fellow eye

4

participants with findings of reticular pseudodrusen (RPD) in the study eye, without advanced AMD in the study eye, and any level of AMD in the fellow eye

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from those already enrolled in protocol 11-EI-0147. Additionally, diabetic participants will be accrued across all groups to analyze the effects of diabetic retinopathy on dark adaptation in the context of the AdaptDxTM device.

You may qualify if:

• Participant was enrolled in and completed 11-EI-0147. The minimum age of enrollment in 11-EI-0147 is 50;
• Participant is able to understand and sign the protocol's informed consent document;
• Participant is able to complete and comply with study assessments for the full duration of the study;
• Participant has a BCVA score of \>= 20/100 (Snellen equivalent) in study eye.

You may not qualify if:

• Participants who meet any of the following criteria will be excluded from this study:
• Participant has advanced AMD in the study eye at the baseline visit;
• The participant has an intercurrent illness, adverse event (AE) or worsening condition;
• Participant has an oral intake of high doses of vitamin A palmitate supplement (\>= 10,000 international units (IU) per day);
• Participant is an NEI employee or subordinate or co-worker of an investigator.

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

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Emily Y Chew, 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: July 20, 2017
• First Posted: July 21, 2017
• Study Start: June 16, 2017
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: June 10, 2026

Record last verified: 2026-06-08

Locations

US (1)