Age-related Macular DegenerationALSTAR2NCT04112667
Functionally Validated Structural Endpoints for Early AMD
An observational study of Age-related Macular Degeneration and Aging, run by Cynthia Owsley at 1 site in United States.
Trial summary
Delayed rod-mediated dark adaptation (RMDA), or delayed recovery of vision in a dark environment, is a functional biomarker (i.e., risk factor) for early age-related macular degeneration (AMD). Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-related Macular Degeneration, Aging
- What is being tested?
- Normal Macular Health, Early Macular Degeneration and Young Normals
- How many people
- 556 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2019to 31 Oct 2024
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: group 1 is >=60 years old with normal macular health group 2 is >=60 years old with early AMD group 3 is 20-30 years old are Young Normals
Who may be able to join
- For those in Normal Macular Health or Early AMD: aged ≥ 60 years; either have normal macular health in both eyes at baseline or have early AMD in one eye For Young Normals: aged 20-30 years old; normal macular health in both eyes.
Who cannot join
- ANY EYE CONDITION OR DISEASE IN EITHER EITHER (OTHER THAN EARLY CATARACT) THAT CAN IMPAIR VISION INCLUDING:
- diabetic retinopathy
- glaucoma
- ocular hypertension
- history of retinal diseases (e.g., retinal vein occlusion, retinal degenerations)
- optic neuritis
Show all 46Show fewer
- corneal disease
- previous ocular trauma or surgery
- REFRACTIVE ERROR >- 6 DIOPTERS
- NEUROLOGICAL CONDITIONS THAT CAN IMPAIR VISION OR JUDGEMENT INCLUDING:
- multiple sclerosis
- Parkinson disease
- stroke
- Alzheimer disease
- seizure disorders
- brain tumor
- traumatic brain injury
- PSYCHIATRIC DISORDERS THAT COULD IMPAIR THE ABILITY:
- to follow simple directions
- answer questions about health and functioning
- or to provide informed consent
- DIABETES
- ANY MEDICAL CONDITION THAT CAUSES SIGNIFICANT FRALITY OR IS BELIEVED TO BE TERMINAL.
- These are identical to those described above, except that it is acceptable for participants to have early AMD (AREDS 2-4) in one eye and be AREDS grade 1 or any stage of AMD in the fellow eye.
- ANY EYE CONDITION OR DISEASE IN EITHER EYE (OTHER THAN EARLY CATARACT) THAT CAN IMPAIR VISION INCLUDING:
- diabetic retinopathy
- glaucoma
- ocular hypertension
- history of retinal diseases (e.g., retinal vein occlusion, retinal degenerations)
- optic neuritis, corneal disease
- previous ocular trauma or surgery
- RERACTIVE ERROR >=6 DIOPTORS
- NEUROLOGICAL CONDITIONS THAT CAN IMPAIR VISION OR JUDGEMENT INCLUDING:
- multiple sclerosis
- Parkinson disease
- stroke
- Alzheimer disease
- seizure disorders
- brain tumor
- traumatic brain injury
- PSYCHIATRIC DISORDERS THAT COULD IMPAIR THE ABILITY TO:
- follow simple directions
- answer questions about health and functioning
- or to provide informed consent
- DIABETES
- ANY MEDICAL CONDITION THAT CAUSES SIGNIFICANT FRAILTY OR IS BELIEVED TO BE TERMINAL.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Delayed rod-mediated dark adaptation (RMDA), or delayed recovery of vision in a dark environment, is a functional biomarker (i.e., risk factor) for early age-related macular degeneration (AMD). This research plan is designed to elucidate the structural (anatomical) basis of this visual deficit using cellular- and subcellular level imaging of the retina and its supporting tissues in living people. An accurate map and timeline of structure-function relationships in persons tested for night vision will result in functionally validated structural endpoints for early AMD trials, as well as define major biologic effects for development into future treatments.
Read the detailed description
The Alabama Study on Early Age-Related Macular Degeneration 2 (ALSTAR2) is a prospective cohort study with baseline measurements that are repeated at follow-up 3 years later. The baseline and 3 year follow-up visits will each consist of 2 visits for a total of 4 visits.
Study assessments are listed below. All are collected at two visits at both baseline and follow-up for 4 visits total (blood collection for DNA analysis at baseline only). For some functional tests (photopic and mesonic acuity, photopic and mesonic contrast sensitivity), each eye will be tested separately. For other functional tests (dark-adapted two-color perimetry, light-adapted cone-mediate perimetry, rod-mediated dark adaptation), only one eye will be tested, which will be designated by the study eye. Tropicamide 1% and phenylephrine hydrochloride 2.5% are used to dilate pupils (diameter of ≥ 6 mm) as needed for specific parts of the protocol. After completing the baseline visits, participants will receive an annual phone call from the study coordinator so that contact information can be updated. Participants will receive an annual newsletter containing study related information (this will be submitted to the IRB for approval).
Study Assessments:
- Rod-mediated dark adaptation (RMDA), the ability to recover light sensitivity after exposure to a bright light.
- Dark-adapted two-color microperimetry, a measure of light sensitivity for lights of two different colors.
- Photopic and mesopic acuity in central vision, as measured by letter charts..
- Photopic and mesopic contrast sensitivity in central vision, as measured by letter charts..
- Multimodal ocular imaging on both eyes, which consists of the following: color fundus photography, spectral domain optical coherence tomography (SDOCT), blue fundus autofluorescence (standard and quantitative), OCT-angiography (OCT-A).
- Blood draw for the analysis of C-reactive protein, high-density lipoprotein, carotenoid level, DNA extraction, and examination of the presence of genetic risk associated with age-related macular degeneration (AMD).
- Questionnaires: Demographics, medical co-morbidities, cognitive status screen, medication use, alcohol use, smoking, self-reported visual difficulty in the visual activities of daily living
The Young normal group will only complete:
- Rod-mediated dark adaptation (RMDA), the ability to recover light sensitivity after exposure to a bright light.
- Dark-adapted two-color microperimetry, a measure of light sensitivity for lights of two different colors.
- . Photopic and mesopic acuity in central vision, as measured by letter charts..
- Photopic and mesopic contrast sensitivity in central vision, as measured by letter charts..
- Multimodal ocular imaging on both eyes, which consists of the following: color fundus photography, spectral domain optical coherence tomography (SDOCT), blue fundus autofluorescence (standard and quantitative),OCT-angiography (OCT-A).d and quantitative), OCT-angiography.
- Conditions
- Age-related Macular Degeneration, Aging
- Being tested
- Normal Macular Health, Early Macular Degeneration, Young Normals
- Keywords
- vision, retina, dark adaptation, light sensitivity, spectral domain optical coherence tomography, quantitative autofluorescence, optical coherence tomography angiography
- Medical subject headings
- Macular Degeneration, Photophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal Macular HealthOther
This group of participants will have function assessed using rod- and cone-mediated tests (rod-mediated dark adaptation, 2 color dark adapted perimetry, cone-mediated perimetry, photopic and mesopic acuity, photopic and mesopic contrast sensitivity). Age-related macular degeneration status will be determined by multi-modal imaging.
Early Macular DegenerationOther
This group of participants will have function assessed using rod- and cone-mediated tests (rod-mediated dark adaptation, 2 color dark adapted perimetry, cone-mediated perimetry, photopic and mesopic acuity, photopic and mesopic contrast sensitivity). Age-related macular degeneration status will be determined by multi-modal imaging.
Young NormalsOther
This group of participants will have function assessed using rod- and cone-mediated tests (rod-mediated dark adaptation, 2 color dark adapted perimetry, cone-mediated perimetry, photopic and mesopic acuity, photopic and mesopic contrast sensitivity). Age-related macular degeneration status will be determined by multi-modal imaging.
| Study group | Role | What they receive |
|---|---|---|
| Normal Macular Health | >=60 years old with no macular disease Receives: Other: Normal Macular Health | |
| Early Macular Degeneration | >=60 years old with early age-related macular degeneration Receives: Other: Early Macular Degeneration | |
| Young Normals | 20-30 years old with normal macular health Receives: Other: Young Normals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rod-mediated dark adaptation
Time required to recover light sensitivity after exposure to bright light
Measured: Measured at baseline enrollment
Rod-mediated dark adaptation
Time required to recover light sensitivity after exposure to bright light
Measured: Measured at 3 years after baseline enrollment
incident age-related macular degeneration (AMD) or progression of AMD using multimodal imaging
development of AMD or progression of AMD at the 3 year follow up visit
Measured: Measured at baseline enrollment
incident age-related macular degeneration (AMD) or progression of AMD using multimodal imaging
development of AMD or progression of AMD at the 3 year follow up visit
Measured: Measured at 3 years after baseline enrollment
Secondary outcomes (6)
Light sensitivity as measured by microperimetry and perimetry
Amount of light needed to detect a small target object
Measured: Measured at baseline enrollment
Light sensitivity as measured by microperimetry and perimetry
Amount of light needed to detect a small target object
Measured: Measured at 3 years after baseline enrollment
Photopic and mesopic acuity
Visual acuity under day time and twilight conditions
Measured: Measured at baseline enrollment
Photopic and mesopic acuity
Visual acuity under day time and twilight conditions
Measured: Measured at 3 years after baseline enrollment
Photopic and mesopic contrast sensitivity
Amount of contrast needed to recognize a letter under day time and twilight conditions
Measured: Measured at baseline enrollment
Photopic and mesopic contrast sensitivity
Amount of contrast needed to recognize a letter under day time and twilight conditions
Measured: Measured at 3 years after baseline enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start7 Oct 2019
- Primary completion1 Jul 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- 556 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cynthia Owsley
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI), National Institutes of Health (NIH)
- Responsible party
- Sponsor-investigator, Cynthia Owsley, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112667
- Sponsor's protocol ID
- IRB-300003067
- Other IDs
- 1R01EY029595
- Acronym
- ALSTAR2
- Status last verified
- Jun 2025
- First submitted
- 30 Sep 2019
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently there is no plan to make individual participant data available to other researchers.
Publications
Owsley C, Curcio CA. Impaired Rod-Mediated Vision is the Functional Hallmark of Ageing and Early and Intermediate Age-Related Macular Degeneration. Ophthalmic Physiol Opt. 2026 Jun 22. doi: 10.1007/s44402-026-00124-1. Online ahead of print.
PubMed 42332292Emamverdi M, Vatanatham C, Fasih-Ahmad S, Wang Z, Mishra Z, Jain A, Ganegoda A, Clark ME, Habibi A, Ashrafkhorasani M, Owsley C, Curcio CA, Hu ZJ, Sadda SR. Probing Deposit-Driven Age-Related Macular Degeneration Via Thicknesses of Outer Retinal Bands and Choroid: ALSTAR2 Baseline. Invest Ophthalmol Vis Sci. 2024 May 1;65(5):17. doi: 10.1167/iovs.65.5.17.
PubMed 38717424Kar D, Corradetti G, Swain TA, Clark ME, McGwin G Jr, Owsley C, Sadda SR, Curcio CA. Choriocapillaris Impairment Is Associated With Delayed Rod-Mediated Dark Adaptation in Age-Related Macular Degeneration. Invest Ophthalmol Vis Sci. 2023 Sep 1;64(12):41. doi: 10.1167/iovs.64.12.41.
PubMed 37768273Berlin A, Matney E, Jones SG, Clark ME, Swain TA, McGwin G Jr, Martindale RM, Sloan KR, Owsley C, Curcio CA. Discernibility of the Interdigitation Zone (IZ), a Potential Optical Coherence Tomography (OCT) Biomarker for Visual Dysfunction in Aging. Curr Eye Res. 2023 Nov;48(11):1050-1056. doi: 10.1080/02713683.2023.2240547. Epub 2023 Aug 4.
PubMed 37539829McGwin G Jr, Kar D, Berlin A, Clark ME, Swain TA, Crosson JN, Sloan KR, Owsley C, Curcio CA. Macular and Plasma Xanthophylls Are Higher in Age-related Macular Degeneration than in Normal Aging: Alabama Study on Early Age-related Macular Degeneration 2 Baseline. Ophthalmol Sci. 2022 Dec 22;3(2):100263. doi: 10.1016/j.xops.2022.100263. eCollection 2023 Jun.
PubMed 36864830Curcio CA, McGwin G Jr, Sadda SR, Hu Z, Clark ME, Sloan KR, Swain T, Crosson JN, Owsley C. Functionally validated imaging endpoints in the Alabama study on early age-related macular degeneration 2 (ALSTAR2): design and methods. BMC Ophthalmol. 2020 May 19;20(1):196. doi: 10.1186/s12886-020-01467-0.
PubMed 32429847
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functionally Validated Structural Endpoints for Early AMD
- ClinicalTrials.gov ID
- NCT04112667
- Acronym / sponsor ID
- ALSTAR2 / IRB-300003067
- Conditions
- Age-related Macular Degeneration, Aging
- Keywords
- vision, retina, dark adaptation, light sensitivity, spectral domain optical coherence tomography, quantitative autofluorescence, optical coherence tomography angiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 556 participants (actual)
- Lead sponsor
- Cynthia OwsleyUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI), National Institutes of Health (NIH)
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 2 Oct 2019 (actual)
- 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.
Delayed rod-mediated dark adaptation (RMDA), or delayed recovery of vision in a dark environment, is a functional biomarker (i.e., risk factor) for early age-related macular degeneration (AMD). This research plan is designed to elucidate the structural (anatomical) basis of this visual deficit using cellular- and subcellular level imaging of the retina and its supporting tissues in living people. An accurate map and timeline of structure-function relationships in persons tested for night vision will result in functionally validated structural endpoints for early AMD trials, as well as define major biologic effects for development into future treatments.
Detailed description
The Alabama Study on Early Age-Related Macular Degeneration 2 (ALSTAR2) is a prospective cohort study with baseline measurements that are repeated at follow-up 3 years later. The baseline and 3 year follow-up visits will each consist of 2 visits for a total of 4 visits.
Study assessments are listed below. All are collected at two visits at both baseline and follow-up for 4 visits total (blood collection for DNA analysis at baseline only). For some functional tests (photopic and mesonic acuity, photopic and mesonic contrast sensitivity), each eye will be tested separately. For other functional tests (dark-adapted two-color perimetry, light-adapted cone-mediate perimetry, rod-mediated dark adaptation), only one eye will be tested, which will be designated by the study eye. Tropicamide 1% and phenylephrine hydrochloride 2.5% are used to dilate pupils (diameter of ≥ 6 mm) as needed for specific parts of the protocol. After completing the baseline visits, participants will receive an annual phone call from the study coordinator so that contact information can be updated. Participants will receive an annual newsletter containing study related information (this will be submitted to the IRB for approval).
Study Assessments:
- Rod-mediated dark adaptation (RMDA), the ability to recover light sensitivity after exposure to a bright light.
- Dark-adapted two-color microperimetry, a measure of light sensitivity for lights of two different colors.
- Photopic and mesopic acuity in central vision, as measured by letter charts..
- Photopic and mesopic contrast sensitivity in central vision, as measured by letter charts..
- Multimodal ocular imaging on both eyes, which consists of the following: color fundus photography, spectral domain optical coherence tomography (SDOCT), blue fundus autofluorescence (standard and quantitative), OCT-angiography (OCT-A).
- Blood draw for the analysis of C-reactive protein, high-density lipoprotein, carotenoid level, DNA extraction, and examination of the presence of genetic risk associated with age-related macular degeneration (AMD).
- Questionnaires: Demographics, medical co-morbidities, cognitive status screen, medication use, alcohol use, smoking, self-reported visual difficulty in the visual activities of daily living
The Young normal group will only complete:
- Rod-mediated dark adaptation (RMDA), the ability to recover light sensitivity after exposure to a bright light.
- Dark-adapted two-color microperimetry, a measure of light sensitivity for lights of two different colors.
- . Photopic and mesopic acuity in central vision, as measured by letter charts..
- Photopic and mesopic contrast sensitivity in central vision, as measured by letter charts..
- Multimodal ocular imaging on both eyes, which consists of the following: color fundus photography, spectral domain optical coherence tomography (SDOCT), blue fundus autofluorescence (standard and quantitative),OCT-angiography (OCT-A).d and quantitative), OCT-angiography.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Macular Health | – | Other: Normal Macular Health>=60 years old with no macular disease |
| Early Macular Degeneration | – | Other: Early Macular Degeneration>=60 years old with early age-related macular degeneration |
| Young Normals | – | Other: Young Normals20-30 years old with normal macular health |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- group 1 is >=60 years old with normal macular health group 2 is >=60 years old with early AMD group 3 is 20-30 years old are Young Normals
Key inclusion criteria (1 listed)
- For those in Normal Macular Health or Early AMD: aged ≥ 60 years; either have normal macular health in both eyes at baseline or have early AMD in one eye For Young Normals: aged 20-30 years old; normal macular health in both eyes.
Key exclusion criteria (46 listed)
- ANY EYE CONDITION OR DISEASE IN EITHER EITHER (OTHER THAN EARLY CATARACT) THAT CAN IMPAIR VISION INCLUDING:
- diabetic retinopathy
- glaucoma
- ocular hypertension
- history of retinal diseases (e.g., retinal vein occlusion, retinal degenerations)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal Macular HealthThis group of participants will have function assessed using rod- and cone-mediated tests (rod-mediated dark adaptation, 2 color dark adapted perimetry, cone-mediated perimetry, photopic and mesopic acuity, photopic and mesopic contrast sensitivity). Age-related macular degeneration status will be determined by multi-modal imaging. | Other | Normal Macular Health |
| Early Macular DegenerationThis group of participants will have function assessed using rod- and cone-mediated tests (rod-mediated dark adaptation, 2 color dark adapted perimetry, cone-mediated perimetry, photopic and mesopic acuity, photopic and mesopic contrast sensitivity). Age-related macular degeneration status will be determined by multi-modal imaging. | Other | Early Macular Degeneration |
| Young NormalsThis group of participants will have function assessed using rod- and cone-mediated tests (rod-mediated dark adaptation, 2 color dark adapted perimetry, cone-mediated perimetry, photopic and mesopic acuity, photopic and mesopic contrast sensitivity). Age-related macular degeneration status will be determined by multi-modal imaging. | Other | Young Normals |
Primary outcome
Rod-mediated dark adaptation
Time frame: Measured at baseline enrollment
Time required to recover light sensitivity after exposure to bright light
Rod-mediated dark adaptation
Time frame: Measured at 3 years after baseline enrollment
Time required to recover light sensitivity after exposure to bright light
incident age-related macular degeneration (AMD) or progression of AMD using multimodal imaging
Time frame: Measured at baseline enrollment
development of AMD or progression of AMD at the 3 year follow up visit
incident age-related macular degeneration (AMD) or progression of AMD using multimodal imaging
Time frame: Measured at 3 years after baseline enrollment
development of AMD or progression of AMD at the 3 year follow up visit
6 secondary outcomes
Light sensitivity as measured by microperimetry and perimetry
Time frame: Measured at baseline enrollment
Light sensitivity as measured by microperimetry and perimetry
Time frame: Measured at 3 years after baseline enrollment
Photopic and mesopic acuity
Time frame: Measured at baseline enrollment
Photopic and mesopic acuity
Time frame: Measured at 3 years after baseline enrollment
Photopic and mesopic contrast sensitivity
Time frame: Measured at baseline enrollment
Photopic and mesopic contrast sensitivity
Time frame: Measured at 3 years after baseline enrollment
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 26 Sep 2025.
- Derived from this study: PubMed 42332292Owsley C, Curcio CA. Impaired Rod-Mediated Vision is the Functional Hallmark of Ageing and Early and Intermediate Age-Related Macular Degeneration. Ophthalmic Physiol Opt. 2026 Jun 22. doi: 10.1007/s44402-026-00124-1. Online ahead of print.
- Derived from this study: PubMed 38717424Emamverdi M, Vatanatham C, Fasih-Ahmad S, Wang Z, Mishra Z, Jain A, Ganegoda A, Clark ME, Habibi A, Ashrafkhorasani M, Owsley C, Curcio CA, Hu ZJ, Sadda SR. Probing Deposit-Driven Age-Related Macular Degeneration Via Thicknesses of Outer Retinal Bands and Choroid: ALSTAR2 Baseline. Invest Ophthalmol Vis Sci. 2024 May 1;65(5):17. doi: 10.1167/iovs.65.5.17.
- Derived from this study: PubMed 37768273Kar D, Corradetti G, Swain TA, Clark ME, McGwin G Jr, Owsley C, Sadda SR, Curcio CA. Choriocapillaris Impairment Is Associated With Delayed Rod-Mediated Dark Adaptation in Age-Related Macular Degeneration. Invest Ophthalmol Vis Sci. 2023 Sep 1;64(12):41. doi: 10.1167/iovs.64.12.41.
- Derived from this study: PubMed 37539829Berlin A, Matney E, Jones SG, Clark ME, Swain TA, McGwin G Jr, Martindale RM, Sloan KR, Owsley C, Curcio CA. Discernibility of the Interdigitation Zone (IZ), a Potential Optical Coherence Tomography (OCT) Biomarker for Visual Dysfunction in Aging. Curr Eye Res. 2023 Nov;48(11):1050-1056. doi: 10.1080/02713683.2023.2240547. Epub 2023 Aug 4.
- Derived from this study: PubMed 36864830McGwin G Jr, Kar D, Berlin A, Clark ME, Swain TA, Crosson JN, Sloan KR, Owsley C, Curcio CA. Macular and Plasma Xanthophylls Are Higher in Age-related Macular Degeneration than in Normal Aging: Alabama Study on Early Age-related Macular Degeneration 2 Baseline. Ophthalmol Sci. 2022 Dec 22;3(2):100263. doi: 10.1016/j.xops.2022.100263. eCollection 2023 Jun.
- Derived from this study: PubMed 32429847Curcio CA, McGwin G Jr, Sadda SR, Hu Z, Clark ME, Sloan KR, Swain T, Crosson JN, Owsley C. Functionally validated imaging endpoints in the Alabama study on early age-related macular degeneration 2 (ALSTAR2): design and methods. BMC Ophthalmol. 2020 May 19;20(1):196. doi: 10.1186/s12886-020-01467-0.
- Individual participant dataSharing planned: No. Currently there is no plan to make individual participant data available to other researchers.
Related trials for Age-related Macular Degeneration
RecruitingPhase 1
A Study About the Safety of a Single ASP2020 Eye Injection and if it Helps People With Vision Loss From Stargardt-type Eye Conditions
Stargardt Disease, Stargardt Macular Dystrophy
RecruitingPhase 1/2
Safety and Efficacy of Oral HX9428 Tablets in Subjects With Wet Age-related Macular Degeneration (wAMD)
Wet Age-related Macular Degeneration (AMD)
Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Neovascular Age-related Macular Degeneration
RecruitingPhase 3
Extension Study for the Port Delivery System With Ranibizumab (Portal)
Neovascular Age-Related Macular Degeneration
RecruitingPhase 3
Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
Neovascular Age-related Macular Degeneration
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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Aging, run by Cynthia Owsley 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 1 inclusion and 46 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 26 Sep 2025. 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?
Rod-mediated dark adaptation (time frame: Measured at baseline enrollment). The study lists 4 primary outcomes in all. 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 NCT04112667, which also lists 6 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 26 Sep 2025.