Trial record 9 of 350 for:    macular degeneration | Open Studies

Study of Dark Adaptation in Age-Related Macular Degeneration

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01352975
First received: May 11, 2011
Last updated: March 14, 2014
Last verified: February 2014

May 11, 2011
March 14, 2014
April 2011
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  • The primary outcome is to determine mean change, including the distribution of change, in dark adaptation response [ Time Frame: Between baseline and months 12 and 24 for Groups 0 - 3 ]
  • 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.
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Complete list of historical versions of study NCT01352975 on ClinicalTrials.gov Archive Site
  • The mean change in dark adaptation response [ Time Frame: From baseline at all time pointsbaseline at all time points ]
  • Mean BCVA change [ Time Frame: From baseline at all time points ]
  • The exploratory outcomes are to correlate mean BCVA with mean dark adaptation response and AMD severity with dark adaptation response [ Time Frame: At baseline compared with all time points ]
  • The secondary outcomes are the mean change in dark adaptation response and mean BCVA change from baseline at all time points.
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Study of Dark Adaptation in Age-Related Macular Degeneration
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.

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: One hundred eighty (180) participants will be initially accrued; however, up to 220 participants who meet the eligibility criteria may be enrolled. Participants will have varying degrees of severity of AMD (Groups 0, 1, 2, and 3). 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. Up to 20 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 and 3. Reproducibility will be evaluated in a minimum of 10 participants with repeat testing performed one week (plus or minus 2 days) following the baseline visit. The secondary outcomes for each of the four 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) from baseline at months 3, 6, 12, 18, 24, 36, 48 and 60. Exploratory outcomes for each of the four groups are to correlate mean BCVA 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. Additionally, exploratory analysis of the small sample of diabetic participants will also be performed.

Observational
Time Perspective: Prospective
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Age-Related Macular Degeneration
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
220
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  • 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.

EXCLUSION CRITERIA:

Participants who meet any of the following criteria will be excluded from this study:

Participant has advanced AMD (as defined in Appendix 1) 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 AdaptRx 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.

Both
50 Years and older
No
Contact: Katherine H Shimel, R.N. (301) 402-2863 shimelk@nei.nih.gov
Contact: Catherine A Cukras, M.D. (301) 435-5061 cukrasc@mail.nih.gov
United States
 
NCT01352975
110147, 11-EI-0147
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National Eye Institute (NEI)
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Principal Investigator: Catherine A Cukras, M.D. National Eye Institute (NEI)
National Institutes of Health Clinical Center (CC)
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP