Age-Related Macular DegenerationNCT01352975
Study of Dark Adaptation in Age-Related Macular Degeneration
An observational study of Age-Related Macular Degeneration, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Age-Related Macular Degeneration
- How many people
- 217 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2011to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Two hundred forty participants (240) will be initially accrued; however, up to 280 participants who meet the eligibility criteria may be enrolled. In the event that a participant withdraws from the study prior to month 12, an additional participant will be accrued. A maximum of 40 non-diabetic participants per group will be accrued in order to obtain 200 non-diabetic participants for the primary outcome analysis. Every effort will be made to ensure 40 non-diabetic participants per group are accrued. Additionally, a maximum of 40 diabetic participants will be accrued across all groups for the exploratory outcome analysis.
Who may be able to join
- 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 >= 50 years of age.
- Participant has a BCVA score of >= 20/100 (Snellen equivalent) in study eye.
- Participant qualifies for one of the following groups based on AMD grading as defined below.
Show all 11Show fewer
- 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 (>= 125 microns) in the study eye and no large drusen or advanced AMD in the fellow eye;
- Group 2: Participant has bilateral large drusen (>= 125 microns) with or without retinal pigment epithelial hypo/hyperpigmentary changes;
- Group 3: Participant has at least one large drusen (>= 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.
Who cannot join
- 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 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.
Show all 10Show fewer
- Participant has an oral intake of high doses of vitamin A palmitate supplement (>= 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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.
Read the detailed description
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). To that aim, correlating structural features (obtained from multimodal imaging) as well as genetic and systemic factors obtained from biospecimens with functional measures (including dark adaptation, visual acuity and low luminance) will be done to understand the relationship of disease relevant factors and to create a model of disease pathogenesis and progression.
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 (>= 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) 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 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. 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 change in 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, including grading by an external Reading Center, with dark adaptation response at baseline and months 3, 6, 12, 18, 24, 36, 48 and 60. Images from all visits may be sent to the Reading Center; however, only the baseline and annual visits are required to be graded. This study will also analyze renal function in AMD participants. Additionally, exploratory analysis of the small sample of diabetic participants will also be performed.
Outcome measures for the genetic testing and RNA sequencing performed on participants co-enrolled in the Biobank protocol (12-EI-0042) include the interaction of key parameters of phenotype (such as visual acuity, dark adaptation, and retinal features on ocular imaging) with genetic variants and other biomarkers identified from biospecimens, and the characterization of new experimental models of eye health and disease.
- Conditions
- Age-Related Macular Degeneration
- Keywords
- Dark Adaptation, Age-Related Macular Degeneration (AMD), Natural History, Age Related Macular Degeneration, AMD
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 0 | participants without AMD (no large drusen or advanced AMD in either eye) | |
| Group 1 | participants with large drusen in study eye and no large drusen or advanced AMD or GA in fellow eye | |
| Group 2 | participants with bilateral large drusen with or without retinal pigment epithelial hypo/hyperpigmentary changes | |
| Group 3 | participants with large drusen in study eye and advanced AMD (CNV and GA) in fellow eye | |
| Group 4 | participants with findings of RPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 - 4.
mean change, including the distribution of change, in dark adaptation response
Measured: Month 12 and Month 24
Secondary outcomes (2)
To determine mean change in dark adaptation response from baseline at months 3, 6, 18, 36, 48 and 60 .
mean change in DA response from baseline
Measured: Months 3, 6, 18, 36, 48 and 60
To determine mean BCVA of the study eye from baseline at months 3, 6, 12, 18, 24, 36, 48 and 60.
mean BCVA of study eye from baseline
Measured: Months 3, 6, 12, 18, 24, 36, 48 and 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2011 (estimated)
- Study start16 May 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Emily Y Chew, M.D., Principal investigator, National Eye Institute (NEI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352975
- Sponsor's protocol ID
- 110147
- Other IDs
- 11-EI-0147
- Status last verified
- 8 Jun 2026
- First submitted
- 11 May 2011
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ferris FL 3rd, Fine SL, Hyman L. Age-related macular degeneration and blindness due to neovascular maculopathy. Arch Ophthalmol. 1984 Nov;102(11):1640-2. doi: 10.1001/archopht.1984.01040031330019.
PubMed 6208888Friedman DS, O'Colmain BJ, Munoz B, Tomany SC, McCarty C, de Jong PT, Nemesure B, Mitchell P, Kempen J; Eye Diseases Prevalence Research Group. Prevalence of age-related macular degeneration in the United States. Arch Ophthalmol. 2004 Apr;122(4):564-72. doi: 10.1001/archopht.122.4.564.
PubMed 15078675Scilley K, Jackson GR, Cideciyan AV, Maguire MG, Jacobson SG, Owsley C. Early age-related maculopathy and self-reported visual difficulty in daily life. Ophthalmology. 2002 Jul;109(7):1235-42. doi: 10.1016/s0161-6420(02)01060-6.
PubMed 12093644Grune T, Lietz G, Palou A, Ross AC, Stahl W, Tang G, Thurnham D, Yin SA, Biesalski HK. Beta-carotene is an important vitamin A source for humans. J Nutr. 2010 Dec;140(12):2268S-2285S. doi: 10.3945/jn.109.119024. Epub 2010 Oct 27.
PubMed 20980645Duic C, Pfau K, Keenan TDL, Wiley H, Thavikulwat A, Chew EY, Cukras C. Hyperreflective Foci in Age-Related Macular Degeneration are Associated with Disease Severity and Functional Impairment. Ophthalmol Retina. 2023 Apr;7(4):307-317. doi: 10.1016/j.oret.2022.11.006. Epub 2022 Nov 17.
PubMed 36403926Hess K, de Silva T, Grisso P, Wiley H, Thavikulwat AT, Keenan TDL, Chew EY, Cukras CA. Evaluation of Cone- and Rod-Mediated Parameters in Dark Adaptation Testing as Outcome Measures in Age-Related Macular Degeneration. Ophthalmol Retina. 2022 Dec;6(12):1173-1184. doi: 10.1016/j.oret.2022.05.018. Epub 2022 May 26.
PubMed 35643387Yazdanie M, Alvarez J, Agron E, Wong WT, Wiley HE, Ferris FL 3rd, Chew EY, Cukras C. Decreased Visual Function Scores on a Low Luminance Questionnaire Is Associated with Impaired Dark Adaptation. Ophthalmology. 2017 Sep;124(9):1332-1339. doi: 10.1016/j.ophtha.2017.05.005. Epub 2017 Jun 8.
PubMed 28602520
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Investigation of Dark Adaptation in Participants With Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01352975
- Acronym / sponsor ID
- 110147
- Conditions
- Age-Related Macular Degeneration
- Keywords
- Dark Adaptation, Age-Related Macular Degeneration (AMD), Natural History, Age Related Macular Degeneration, AMD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 16 May 2011 (actual)
- First posted
- 12 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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). To that aim, correlating structural features (obtained from multimodal imaging) as well as genetic and systemic factors obtained from biospecimens with functional measures (including dark adaptation, visual acuity and low luminance) will be done to understand the relationship of disease relevant factors and to create a model of disease pathogenesis and progression.
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 (>= 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) 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 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. 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 change in 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, including grading by an external Reading Center, with dark adaptation response at baseline and months 3, 6, 12, 18, 24, 36, 48 and 60. Images from all visits may be sent to the Reading Center; however, only the baseline and annual visits are required to be graded. This study will also analyze renal function in AMD participants. Additionally, exploratory analysis of the small sample of diabetic participants will also be performed.
Outcome measures for the genetic testing and RNA sequencing performed on participants co-enrolled in the Biobank protocol (12-EI-0042) include the interaction of key parameters of phenotype (such as visual acuity, dark adaptation, and retinal features on ocular imaging) with genetic variants and other biomarkers identified from biospecimens, and the characterization of new experimental models of eye health and disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 0 | – | –participants without AMD (no large drusen or advanced AMD in either eye) |
| Group 1 | – | –participants with large drusen in study eye and no large drusen or advanced AMD or GA in fellow eye |
| Group 2 | – | –participants with bilateral large drusen with or without retinal pigment epithelial hypo/hyperpigmentary changes |
| Group 3 | – | –participants with large drusen in study eye and advanced AMD (CNV and GA) in fellow eye |
| Group 4 | – | –participants with findings of RPD |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Two hundred forty participants (240) will be initially accrued; however, up to 280 participants who meet the eligibility criteria may be enrolled. In the event that a participant withdraws from the study prior to month 12, an additional participant will be accrued. A maximum of 40 non-diabetic participants per group will be accrued in order to obtain 200 non-diabetic participants for the primary outcome analysis. Every effort will be made to ensure 40 non-diabetic participants per group are accrued. Additionally, a maximum of 40 diabetic participants will be accrued across all groups for the exploratory outcome analysis.
Key inclusion criteria (11 listed)
- 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 >= 50 years of age.
- Participant has a BCVA score of >= 20/100 (Snellen equivalent) in study eye.
- Participant qualifies for one of the following groups based on AMD grading as defined below.
Key exclusion criteria (10 listed)
- 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 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 - 4.
Time frame: Month 12 and Month 24
mean change, including the distribution of change, in dark adaptation response
2 secondary outcomes
To determine mean change in dark adaptation response from baseline at months 3, 6, 18, 36, 48 and 60 .
Time frame: Months 3, 6, 18, 36, 48 and 60
To determine mean BCVA of the study eye from baseline at months 3, 6, 12, 18, 24, 36, 48 and 60.
Time frame: Months 3, 6, 12, 18, 24, 36, 48 and 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 6208888Ferris FL 3rd, Fine SL, Hyman L. Age-related macular degeneration and blindness due to neovascular maculopathy. Arch Ophthalmol. 1984 Nov;102(11):1640-2. doi: 10.1001/archopht.1984.01040031330019.
- Background: PubMed 15078675Friedman DS, O'Colmain BJ, Munoz B, Tomany SC, McCarty C, de Jong PT, Nemesure B, Mitchell P, Kempen J; Eye Diseases Prevalence Research Group. Prevalence of age-related macular degeneration in the United States. Arch Ophthalmol. 2004 Apr;122(4):564-72. doi: 10.1001/archopht.122.4.564.
- Background: PubMed 12093644Scilley K, Jackson GR, Cideciyan AV, Maguire MG, Jacobson SG, Owsley C. Early age-related maculopathy and self-reported visual difficulty in daily life. Ophthalmology. 2002 Jul;109(7):1235-42. doi: 10.1016/s0161-6420(02)01060-6.
- Background: PubMed 20980645Grune T, Lietz G, Palou A, Ross AC, Stahl W, Tang G, Thurnham D, Yin SA, Biesalski HK. Beta-carotene is an important vitamin A source for humans. J Nutr. 2010 Dec;140(12):2268S-2285S. doi: 10.3945/jn.109.119024. Epub 2010 Oct 27.
- Derived from this study: PubMed 36403926Duic C, Pfau K, Keenan TDL, Wiley H, Thavikulwat A, Chew EY, Cukras C. Hyperreflective Foci in Age-Related Macular Degeneration are Associated with Disease Severity and Functional Impairment. Ophthalmol Retina. 2023 Apr;7(4):307-317. doi: 10.1016/j.oret.2022.11.006. Epub 2022 Nov 17.
- Derived from this study: PubMed 35643387Hess K, de Silva T, Grisso P, Wiley H, Thavikulwat AT, Keenan TDL, Chew EY, Cukras CA. Evaluation of Cone- and Rod-Mediated Parameters in Dark Adaptation Testing as Outcome Measures in Age-Related Macular Degeneration. Ophthalmol Retina. 2022 Dec;6(12):1173-1184. doi: 10.1016/j.oret.2022.05.018. Epub 2022 May 26.
- Derived from this study: PubMed 28602520Yazdanie M, Alvarez J, Agron E, Wong WT, Wiley HE, Ferris FL 3rd, Chew EY, Cukras C. Decreased Visual Function Scores on a Low Luminance Questionnaire Is Associated with Impaired Dark Adaptation. Ophthalmology. 2017 Sep;124(9):1332-1339. doi: 10.1016/j.ophtha.2017.05.005. Epub 2017 Jun 8.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Age-Related Macular Degeneration
RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
RecruitingObservational study
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Age-related Macular Degeneration (AMD)
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Y Chew, M.D. principal investigator
National Eye Institute (NEI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-Related Macular Degeneration, run by National Eye Institute (NEI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 - 4. (time frame: Month 12 and Month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01352975, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.