In this clinical trial, investigators are trying to see how effective dark adaptation protocol is in identifying and monitoring middle dry age-related macular degeneration (AMD). The hope is that this will help develop treatments to stop the disease before it becomes more severe. The study will monitor how people with early dry AMD’s eyes adjust to the dark to see if that can help determine if they get the more serious form of AMD.
In the study, participants will be screened via physical exam, medical history, blood and urine tests, and a full eye exam. Through the course of the study, participants will be required to visit the NIH at least 9 times over 5 years with a first visit, then visits every three months for a year, then every six months, then every year for the final 3 years. After the initial screening, up to 10 people will be asked to return to the clinic a week later to test the device.
At each visit, participants will answer questions about health and medications, receive a full eye exam, and a test to measure how fast the eyes recover in response to decreasing levels of light as well as sensitivity. They will also be treated with the standard of care for eye conditions that they already have or develop during the study. Up to 280 participants may be enrolled and put into groups with varying degrees of severity of AMD.
- 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 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, Stargardts 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.
National Institutes of Health Clinical Center, 9000 Rockville Pike
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 firstname.lastname@example.org
National Eye Institute (NEI)
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