Study of Dark Adaptation in Age-Related Macular Degeneration
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01352975|
Recruitment Status : Recruiting
First Posted : May 12, 2011
Last Update Posted : February 6, 2020
- 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.
- To evaluate the effectiveness of using a dark adaptation protocol to identify and monitor early to middle dry age-related macular degeneration.
- People at least 50 years of age who have no AMD. Others who have early to middle dry AMD in at least one eye.
- 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.
|Condition or disease|
|Age-Related Macular Degeneration|
Objective: This study is designed to investigate the use of dark adaptation as a functional endpoint for progression of eyes with no to intermediate age-related macular degeneration (AMD).
Study Population: Two hundred forty (240) participants will be initially accrued; however, up to 280 participants who meet the eligibility criteria may be enrolled. Participants will have varying degrees of severity of AMD (Groups 0, 1, 2, 3 and 4). Group 0 (N=40) is defined as participants without AMD meaning no large drusen (greater than or equal to 125 microns) or advanced AMD in either eye. Group 1 (N=40) is defined as participants with large drusen (greater than or equal to 125 microns) in the study eye and no large drusen or advanced AMD (choroidal neovascularization (CNV) or geographic atrophy (GA)) in the fellow eye. Group 2 (N=40) is defined as participants with bilateral large drusen (greater than or equal to 125 microns) with or without retinal pigment epithelial hypo/hyperpigmentary changes. Group 3 (N=40) is defined as participants with large drusen (greater than or equal to 125 microns) in the study eye and advanced AMD (CNV or GA) in the fellow eye. Group 4 (N=40) is defined as participants with findings of reticular pseudodrusen (RPD) defined as having (1) the presence of reticular interlacing patterns 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 retinal pigment epithelium (RPE) and the photoreceptor ellipsoid zone on SD OCT in those areas. Current participants in this study have been graded and categorized into this cohort. Up to 40 diabetic participants will be recruited.
Design: This is a single center, exploratory, observational, longitudinal evaluation of dark adaptation response in AMD participants over five years and long-term evaluation of dark adaptometry (DA) change as a predictor for AMD progression and visual acuity (VA) loss.
Outcome Measures: 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, 1, 2, 3 and 4. Reproducibility between the Adapt RxTM (the research prototype of the AdaptDxTM) and the commercial AdaptDxTM will be evaluated in a minimum of 10 participants with repeat testing performed one week (- 6 days/+ 14 days) following the baseline visit. The secondary outcomes for each of the five groups are to determine mean change in dark adaptation response from baseline at months 3, 6, 18, 36, 48 and 60 and to determine mean best-corrected visual acuity (BCVA) of the study eye from baseline at months 3, 6, 12, 18, 24, 36, 48 and 60. Exploratory outcomes for each of the five groups are to correlate mean BCVA of the study eye with mean dark adaptation response at baseline and months 3, 6, 12, 18, 24, 36, 48 and 60 and to correlate AMD severity with dark adaptation response at baseline and months 3, 6, 12, 18, 24, 36, 48 and 60. Images from all visits may be sent to the Reading Center; however, only the baseline and annual visits are required to be graded. This study will also analyze renal function in AMD participants. Additionally, exploratory analysis of the small sample of diabetic participants will also be performed.
|Study Type :||Observational|
|Estimated Enrollment :||280 participants|
|Official Title:||Longitudinal Investigation of Dark Adaptation in Participants With Age-Related Macular Degeneration|
|Actual Study Start Date :||May 16, 2011|
participants without AMD (no large drusen or advanced AMD in either eye)
Participants with large drusen in the study eye and no large drusen or advanced AMD or GA in the fellow eye.
Participants with bilateral large drusen with or without retinal pigment epithelial hypo/hyperpigmentary changes
Participants with large drusen in the study eye and advanced AMD (CNV or GA) in the fellow eye
Participants with findings of RPD
- 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. [ Time Frame: Month 12 and Month 24 ]mean change, including the distribution of change, in dark adaptation response
- To determine mean change in dark adaptation response from baseline at months 3, 6, 18, 36, 48 and 60. [ Time Frame: Baseline, months 3,6,18,36,48 and 60 ]mean changes in DA response from baseline
- To determine mean BCVA of the study eye from baseline at months 3, 6, 12, 18, 24, 36, 48 and 60. [ Time Frame: Baseline, months 3,6,12,18,24,36,48 and 60 ]mean BCVA of study eye from baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01352975
|Contact: Angel H Garced, R.N.||(301) firstname.lastname@example.org|
|Contact: Catherine A Cukras, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Catherine A Cukras, M.D.||National Eye Institute (NEI)|