Study of Dark Adaptation in Age-Related Macular Degeneration
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 2/10/2019 |
| Start Date: | January 1, 2012 |
| Contact: | Angel H Garced, R.N. |
| Email: | garceda@nei.nih.gov |
| Phone: | (301) 594-3141 |
Longitudinal Investigation of Dark Adaptation in Participants With Age-Related Macular Degeneration
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.
- 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.
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. This study will also analyze renal function in AMD participants.
Additionally, exploratory analysis of the small sample of diabetic participants will also be
performed.
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. This study will also analyze renal function in AMD participants.
Additionally, exploratory analysis of the small sample of diabetic participants will also be
performed.
- INCLUSION CRITERIA:
Participants will be eligible if the following inclusion criteria are met:
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 greater than or equal to 50 years of age.
Participant has a BCVA score of greater than or equal to 20/100 (Snellen equivalent) in
study eye.
Participant qualifies for one of the following groups based on AMD grading as defined
below. Advanced AMD is defined in Appendix 1.
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 (greater than or equal to 125 microns)
in the study eye and no large drusen or advanced AMD in the fellow eye;
Group 2: Participant has bilateral large drusen (greater than or equal to 125 microns) with
or without retinal pigment epithelial hypo/hyperpigmentary changes;
Group 3: Participant has at least one large drusen (greater than or equal to 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 retinal pigment epithelium (RPE) and the photoreceptor
ellipsoid zone on SD OCT in those areas.
EXCLUSION CRITERIA:
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 AdaptRxTM/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 (greater
than or equal to 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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