Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dark Adaptation in Participants With 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: NCT03225131
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )

Brief Summary:

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.


Condition or disease
Age-Related Macular Degeneration

Detailed Description:

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 (>= 125 microns) or advanced AMD in either eye. Group 1 (N=40) is defined as participants with large drusen (>= 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 (>= 125 microns) with or without retinal pigment epithelial hypo/hyperpigmentary changes. Group 3 (N=40) is defined as participants with large drusen (>= 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 en 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 dark adaptometry (DA) change as a predictor for AMD progression and visual acuity (VA) loss. For the second five-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 and minus 6 weeks, except for the baseline visit which will be plus and 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 AdaptDxTM technology and also using the Medmont dark adaptation perimeter. 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 the two methods, and the mean change in best-corrected visual acuity (BCVA) of the study eye from baseline and months 12, 24, 36, 48 and 60.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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)
Actual Study Start Date : June 16, 2017
Estimated Primary Completion Date : December 31, 2029
Estimated Study Completion Date : December 31, 2029

Resource links provided by the National Library of Medicine


Group/Cohort
0
participants without AMD meaning no large drusen (>= 125 microns) or advanced AMD in either eye
1
participants with large drusen (>= 125 microns) in the study eye and no large drusen or advanced AMD (choroidal neovascularization (CNV) or geographic atrophy (GA)) in the fellow eye
2
participants with bilateral large drusen (>= 125 microns) with or without retinal pigment epithelial hypo/hyperpigmentary changes
3
participants with large drusen (>= 125 microns) in the study eye and advanced AMD (CNV or GA) in the fellow eye
4
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



Primary Outcome Measures :
  1. The primary objective will be to determine mean change, including distribution of change in dark adaptation response between baseline and months 12, 24 and 60 in participants with varying degree of severity of AMD. [ Time Frame: Months 12 and 24 ]
    The primary objective will be to determine mean change, including distribution of change in dark adaptation response between baselineand months 12, 24 and 60 in participants with varying degree of severity of AMD.


Secondary Outcome Measures :
  1. The mean change in dark adaptation and other characteristic parameters of the dark adaptation response from baseline at months 12,24,36,48,60, and the mean best-corrected visual acuity (BCVA) of the study eye from baseline and months 12,24,36,48... [ Time Frame: Months 3.6.12, 18, 24, 36, 48 and 60 ]
    The primary objective will be to determine mean change, including distribution of change in dark adaptation response between baseline and months 12, 24 and 60 in participants with varying degree of severity of AMD.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be recruited from those already enrolled in protocol 11-EI-0147. Additionally, diabetic participants will be accrued across all groups to analyze the effects of diabetic retinopathy on dark adaptation in the context of the AdaptRx and AdaptDx devices.
Criteria
  • 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.

Information from the National Library of Medicine

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): NCT03225131


Contacts
Layout table for location contacts
Contact: Angel H Garced, R.N. (301) 594-3141 garceda@nei.nih.gov

Locations
Layout table for location information
United States, Maryland
National Institutes of Health Clinical Center 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    prpl@cc.nih.gov   
Sponsors and Collaborators
National Eye Institute (NEI)
Investigators
Layout table for investigator information
Principal Investigator: Catherine A Cukras, M.D. National Eye Institute (NEI)
Additional Information:
Layout table for additonal information
Responsible Party: National Eye Institute (NEI)
ClinicalTrials.gov Identifier: NCT03225131    
Other Study ID Numbers: 170112
17-EI-0112
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: August 3, 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) ):
Age Related Macular Degeneration
Dark Adaptation
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases