Study of Dark Adaptation in Age-Related Macular Degeneration
|First Received Date ICMJE||May 11, 2011|
|Last Updated Date||June 13, 2017|
|Start Date ICMJE||April 18, 2011|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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 0-3. [ Time Frame: Baseline, 12 months, 24 months ]|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01352975 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Study of Dark Adaptation in Age-Related Macular Degeneration|
|Official Title ICMJE||Longitudinal Investigation of Dark Adaptation in Participants With Age-Related Macular Degeneration|
- 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.
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Age-Related Macular Degeneration|
|Intervention ICMJE||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||280|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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 1 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.
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 participating in the AREDS2 protocol.
Participant is an NEI employee or subordinate or co-worker of an investigator.
|Ages||50 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01352975|
|Other Study ID Numbers ICMJE||110147
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )|
|Study Sponsor ICMJE||National Eye Institute (NEI)|
|Collaborators ICMJE||Not Provided|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||June 5, 2017|
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