Study of Dark Adaptation in Age-Related Macular Degeneration

NCT01352975 | Completed

• 2 other identifiers: 11014711-EI-0147
• Study Type: observational
• Target: 217
• Locations: 1 country
• Sites: 1

Brief Summary

Background:

• Age-related macular degeneration (AMD) is a leading cause of vision loss in individuals over 55 years of age. It can cause permanent loss of central vision, which is important for seeing fine details and long distances. AMD has two forms: wet AMD and dry AMD. Most people with AMD have dry AMD. But dry AMD can progress to wet AMD. Wet AMD is the more serious form and can result in severe vision loss.
• A method to identify and monitor the early to middle stages of AMD may help researchers develop new treatments to stop the disease before it becomes severe. In early dry AMD, people cannot see well at night. Researchers want to study whether a procedure that measures how the eye adjusts to the dark can help to identify and monitor early to middle dry AMD. Objectives: \- To evaluate the effectiveness of using a dark adaptation protocol to identify and monitor early to middle dry age-related macular degeneration. Eligibility: \- People at least 50 years of age who have no AMD. Others who have early to middle dry AMD in at least one eye. Design:
• People will be screened with a physical examination, medical history, blood and urine tests, and a full eye exam.
• This study will last 5 years and require at least 9 visits to NIH. (First visit; study visits at months 3, 6, 12, 18, and 24; and 3 yearly followup visits).
• Up to 10 people will be asked to come back to the clinic 1 week after their first visit. They will be asked to test the device to be used in the study.
• Participants will have baseline exams. These questions will be about problems that affect their eyes under different lighting conditions.
• At every visit, participants will answer questions about general health and current medications (including any vitamins or supplements). They will also have a full eye exam and a 20- to 40-minute test. This test measures how fast the eyes recover in response to decreasing levels of light. The test also measures how sensitive the eyes are to these conditions.
• Participants will continue to have these tests at the yearly followup examinations. They will be treated with the standard of care for any eye conditions they have or may develop during the study.

Conditions

Age-Related Macular Degeneration

Keywords

Dark Adaptation; Age-Related Macular Degeneration (AMD); Natural History; Age Related Macular Degeneration; AMD

Outcome Measures

Primary Outcomes (1)

• The primary outcome is to determine mean change, including the distribution of change, in dark adaptation response between baseline and months 12 and 24 for Groups 0 - 4.

  mean change, including the distribution of change, in dark adaptation response

  Month 12 and Month 24

Secondary Outcomes (2)

• To determine mean change in dark adaptation response from baseline at months 3, 6, 18, 36, 48 and 60 .

  Months 3, 6, 18, 36, 48 and 60

• To determine mean BCVA of the study eye from baseline at months 3, 6, 12, 18, 24, 36, 48 and 60.

  Months 3, 6, 12, 18, 24, 36, 48 and 60

Study Arms (5)

Group 0

participants without AMD (no large drusen or advanced AMD in either eye)

Group 1

participants with large drusen in study eye and no large drusen or advanced AMD or GA in fellow eye

Group 2

participants with bilateral large drusen with or without retinal pigment epithelial hypo/hyperpigmentary changes

Group 3

participants with large drusen in study eye and advanced AMD (CNV and GA) in fellow eye

Group 4

participants with findings of RPD

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

Two hundred forty participants (240) will be initially accrued; however, up to 280 participants who meet the eligibility criteria may be enrolled. In the event that a participant withdraws from the study prior to month 12, an additional participant will be accrued. A maximum of 40 non-diabetic participants per group will be accrued in order to obtain 200 non-diabetic participants for the primary outcome analysis. Every effort will be made to ensure 40 non-diabetic participants per group are accrued. Additionally, a maximum of 40 diabetic participants will be accrued across all groups for the exploratory outcome analysis.

You may qualify if:

• 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 is \>= 50 years of age.
• Participant has a BCVA score of \>= 20/100 (Snellen equivalent) in study eye.
• Participant qualifies for one of the following groups based on AMD grading as defined below.
• Group 0: Participant without AMD defined as no large drusen or advanced AMD in either eye;
• Group 1: Participant has at least one large drusen (\>= 125 microns) in the study eye and no large drusen or advanced AMD in the fellow eye;
• Group 2: Participant has bilateral large drusen (\>= 125 microns) with or without retinal pigment epithelial hypo/hyperpigmentary changes;
• Group 3: Participant has at least one large drusen (\>= 125 microns) in the study eye and advanced AMD in the fellow eye.
• Group 4: Participant has reticular pseudodrusen in the study eye defined as having (1) the presence of RPD on at least one en face imaging method (color photography, autofluorescence or infrared) and (2) confirmation of previously described findings of hyperreflective material located between the RPE and the photoreceptor ellipsoid zone on SD OCT in those areas.

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.
• Participant has other active ocular or macular diseases (e.g., diabetic macular edema, retinal vein occlusion, Stargardt's disease or cone-rod dystrophy) or other known ocular disorders that have caused a visual field deficit (e.g., glaucoma with known visual field defect) in the study eye.
• Participant has a fixation deficit in the study eye that would prevent the participant from performing the AdaptDxTM dark adaptation protocol.
• Participant has a medical condition that the investigator feels would prevent the participant from complying with or being able to complete the study assessments.
• Participant had cataract surgery in the study eye within three months prior to enrollment.
• Participant has an oral intake of high doses of vitamin A palmitate supplement (\>= 10,000 international units (IU) per day).
• Participant has or had hepatitis or liver disease. Abnormally low vitamin A can alter dark adaptation and chronic liver disease has been associated with low vitamin A.
• Participant has a history of vitamin A deficiency.
• 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 Publications (7)

• Ferris FL 3rd, Fine SL, Hyman L. Age-related macular degeneration and blindness due to neovascular maculopathy. Arch Ophthalmol. 1984 Nov;102(11):1640-2. doi: 10.1001/archopht.1984.01040031330019.

  PMID: 6208888 BACKGROUND

• Friedman DS, O'Colmain BJ, Munoz B, Tomany SC, McCarty C, de Jong PT, Nemesure B, Mitchell P, Kempen J; Eye Diseases Prevalence Research Group. Prevalence of age-related macular degeneration in the United States. Arch Ophthalmol. 2004 Apr;122(4):564-72. doi: 10.1001/archopht.122.4.564.

  PMID: 15078675 BACKGROUND

• Scilley K, Jackson GR, Cideciyan AV, Maguire MG, Jacobson SG, Owsley C. Early age-related maculopathy and self-reported visual difficulty in daily life. Ophthalmology. 2002 Jul;109(7):1235-42. doi: 10.1016/s0161-6420(02)01060-6.

  PMID: 12093644 BACKGROUND

• Grune T, Lietz G, Palou A, Ross AC, Stahl W, Tang G, Thurnham D, Yin SA, Biesalski HK. Beta-carotene is an important vitamin A source for humans. J Nutr. 2010 Dec;140(12):2268S-2285S. doi: 10.3945/jn.109.119024. Epub 2010 Oct 27.

  PMID: 20980645 BACKGROUND

• Duic C, Pfau K, Keenan TDL, Wiley H, Thavikulwat A, Chew EY, Cukras C. Hyperreflective Foci in Age-Related Macular Degeneration are Associated with Disease Severity and Functional Impairment. Ophthalmol Retina. 2023 Apr;7(4):307-317. doi: 10.1016/j.oret.2022.11.006. Epub 2022 Nov 17.

  PMID: 36403926 DERIVED

• Hess K, de Silva T, Grisso P, Wiley H, Thavikulwat AT, Keenan TDL, Chew EY, Cukras CA. Evaluation of Cone- and Rod-Mediated Parameters in Dark Adaptation Testing as Outcome Measures in Age-Related Macular Degeneration. Ophthalmol Retina. 2022 Dec;6(12):1173-1184. doi: 10.1016/j.oret.2022.05.018. Epub 2022 May 26.

  PMID: 35643387 DERIVED

• Yazdanie M, Alvarez J, Agron E, Wong WT, Wiley HE, Ferris FL 3rd, Chew EY, Cukras C. Decreased Visual Function Scores on a Low Luminance Questionnaire Is Associated with Impaired Dark Adaptation. Ophthalmology. 2017 Sep;124(9):1332-1339. doi: 10.1016/j.ophtha.2017.05.005. Epub 2017 Jun 8.

  PMID: 28602520 DERIVED

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: May 11, 2011
• First Posted: May 12, 2011
• Study Start: May 16, 2011
• Last Updated: June 11, 2026

Record last verified: 2026-06-08

Locations

US (1)