Dark Adaptation in Participants With Age-Related Macular Degeneration
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 10/24/2018 |
| Start Date: | June 16, 2017 |
| End Date: | March 28, 2028 |
A Long-term Follow-up Study of Participants Enrolled in 11-EI-0147: Longitudinal Investigation of Dark Adaptation in Participants With Age-Related Macular Degeneration (DA_AMD)
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.
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.
Objective: The Dark Adaptation Extension study allows us to continue with the follow-up of
participants who were enrolled in the clinical trial, 11-EI-0147, Longitudinal Investigation
of Dark Adaptation in Participants with Age-Related Macular Degeneration, investigating
long-term changes in dark adaptation in participants with a range of age-related macular
degeneration severity who have already been characterized and followed under that protocol.
Study Population: Participants will be recruited from participants already enrolled in
11-EI-0147. 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) in the study eye, without advanced AMD in the study eye, and any level of AMD in the
fellow eye. RPD is defined as having (1) the presence of reticular inter-lacing patterns on
at least one on face imaging method (color photography, autofluorescence or infrared) and (2)
confirmation of previously described findings of hyper-reflective material located between
the retinal pigment epithelium (RPE) and the photoreceptor ellipsoid zone on SD OCT in those
areas. 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 who have been followed over five years and will be
followed over an additional five years to determine long-term evaluation of DA change as a
predictor for AMD progression and VA loss. For the second 5-year study period, participants
will have six required study visits (baseline, 12, 24, 36, 48 and 60), continuing on an
annual basis following exit from 11-EI-0147, for a total follow-up period of 11 years across
both protocols. The windows surrounding each study visit will be plus or minus 6 weeks,
except for the baseline visit which will be plus or minus 8 weeks.
Outcome Measures: 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). Primary
outcome data collected at Month 48 will be compared to the initial baseline testing done in
11-EI-0147 which will be 10-year data across both protocols. Dark adaptation parameters will
be measured using the AdaptDx technology (including the prototype machine, AdaptRx and the
commercially available AdaptDx) and also using the Medmont dark adaptation perimeter.
Reproducibility of the AdaptRx and AdaptDx dark adaptometers as well as the Medmont
perimeterwill be evaluated in a minimum of 20 participants from Groups 0, 1 and 2 with repeat
testing performed one week ( 6 days/+ 14 days) following the baseline visit. The secondary
outcomes include the mean change in dark adaptation and other characteristic parameters of
the dark adaptation response from baseline at months 12, 24, 36, 48 and 60 from each of the
three methods, and the mean best-corrected visual acuity (BCVA) of the study eye from
baseline and months 12, 24, 36, 48 and 60.
participants who were enrolled in the clinical trial, 11-EI-0147, Longitudinal Investigation
of Dark Adaptation in Participants with Age-Related Macular Degeneration, investigating
long-term changes in dark adaptation in participants with a range of age-related macular
degeneration severity who have already been characterized and followed under that protocol.
Study Population: Participants will be recruited from participants already enrolled in
11-EI-0147. 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) in the study eye, without advanced AMD in the study eye, and any level of AMD in the
fellow eye. RPD is defined as having (1) the presence of reticular inter-lacing patterns on
at least one on face imaging method (color photography, autofluorescence or infrared) and (2)
confirmation of previously described findings of hyper-reflective material located between
the retinal pigment epithelium (RPE) and the photoreceptor ellipsoid zone on SD OCT in those
areas. 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 who have been followed over five years and will be
followed over an additional five years to determine long-term evaluation of DA change as a
predictor for AMD progression and VA loss. For the second 5-year study period, participants
will have six required study visits (baseline, 12, 24, 36, 48 and 60), continuing on an
annual basis following exit from 11-EI-0147, for a total follow-up period of 11 years across
both protocols. The windows surrounding each study visit will be plus or minus 6 weeks,
except for the baseline visit which will be plus or minus 8 weeks.
Outcome Measures: 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). Primary
outcome data collected at Month 48 will be compared to the initial baseline testing done in
11-EI-0147 which will be 10-year data across both protocols. Dark adaptation parameters will
be measured using the AdaptDx technology (including the prototype machine, AdaptRx and the
commercially available AdaptDx) and also using the Medmont dark adaptation perimeter.
Reproducibility of the AdaptRx and AdaptDx dark adaptometers as well as the Medmont
perimeterwill be evaluated in a minimum of 20 participants from Groups 0, 1 and 2 with repeat
testing performed one week ( 6 days/+ 14 days) following the baseline visit. The secondary
outcomes include the mean change in dark adaptation and other characteristic parameters of
the dark adaptation response from baseline at months 12, 24, 36, 48 and 60 from each of the
three methods, and the mean best-corrected visual acuity (BCVA) of the study eye from
baseline and months 12, 24, 36, 48 and 60.
- INCLUSION CRITERIA:
Participants will be eligible if the following inclusion criteria are met:
1. Participant was enrolled in and completed 11-EI-0147. The minimum age of enrollment in
11-EI-0147 is 50.
2. Participant is able to understand and sign the protocol s informed consent document.
3. Participant is able to complete and comply with study assessments for the full
duration of the study.
4. Participant has a BCVA score of greater than or equal to 20/100 (Snellen equivalent)
in study eye.
EXCLUSION CRITERIA:
Participants who meet any of the following criteria will be excluded from this study:
1. Participant has advanced AMD in the study eye at the baseline visit.
2. The participant has an intercurrent illness, adverse event or worsening condition.
3. 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).
4. 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
301-496-2563
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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