Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-09 @ 7:36 AM
Study NCT ID:
NCT04112667
Status:
COMPLETED
Last Update Posted:
2025-09-26
First Post:
2019-09-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functionally Validated Structural Endpoints for Early AMD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D020795', 'term': 'Photophobia'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum for DNA for genotyping. Serum for Biomarkers.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 556}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2019-09-30', 'studyFirstSubmitQcDate': '2019-09-30', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rod-mediated dark adaptation', 'timeFrame': 'Measured at baseline enrollment', 'description': 'Time required to recover light sensitivity after exposure to bright light'}, {'measure': 'Rod-mediated dark adaptation', 'timeFrame': 'Measured at 3 years after baseline enrollment', 'description': 'Time required to recover light sensitivity after exposure to bright light'}, {'measure': 'incident age-related macular degeneration (AMD) or progression of AMD using multimodal imaging', 'timeFrame': 'Measured at baseline enrollment', 'description': 'development of AMD or progression of AMD at the 3 year follow up visit'}, {'measure': 'incident age-related macular degeneration (AMD) or progression of AMD using multimodal imaging', 'timeFrame': 'Measured at 3 years after baseline enrollment', 'description': 'development of AMD or progression of AMD at the 3 year follow up visit'}], 'secondaryOutcomes': [{'measure': 'Light sensitivity as measured by microperimetry and perimetry', 'timeFrame': 'Measured at baseline enrollment', 'description': 'Amount of light needed to detect a small target object'}, {'measure': 'Light sensitivity as measured by microperimetry and perimetry', 'timeFrame': 'Measured at 3 years after baseline enrollment', 'description': 'Amount of light needed to detect a small target object'}, {'measure': 'Photopic and mesopic acuity', 'timeFrame': 'Measured at baseline enrollment', 'description': 'Visual acuity under day time and twilight conditions'}, {'measure': 'Photopic and mesopic acuity', 'timeFrame': 'Measured at 3 years after baseline enrollment', 'description': 'Visual acuity under day time and twilight conditions'}, {'measure': 'Photopic and mesopic contrast sensitivity', 'timeFrame': 'Measured at baseline enrollment', 'description': 'Amount of contrast needed to recognize a letter under day time and twilight conditions'}, {'measure': 'Photopic and mesopic contrast sensitivity', 'timeFrame': 'Measured at 3 years after baseline enrollment', 'description': 'Amount of contrast needed to recognize a letter under day time and twilight conditions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vision', 'retina', 'dark adaptation', 'light sensitivity', 'spectral domain optical coherence tomography', 'quantitative autofluorescence', 'optical coherence tomography angiography'], 'conditions': ['Age-related Macular Degeneration', 'Aging']}, 'referencesModule': {'references': [{'pmid': '37768273', 'type': 'DERIVED', 'citation': 'Kar 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.'}, {'pmid': '37539829', 'type': 'DERIVED', 'citation': 'Berlin 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.'}, {'pmid': '36864830', 'type': 'DERIVED', 'citation': 'McGwin 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.'}, {'pmid': '32429847', 'type': 'DERIVED', 'citation': 'Curcio 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nStudy 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).\n\nStudy Assessments:\n\n1. Rod-mediated dark adaptation (RMDA), the ability to recover light sensitivity after exposure to a bright light.\n2. Dark-adapted two-color microperimetry, a measure of light sensitivity for lights of two different colors.\n3. Photopic and mesopic acuity in central vision, as measured by letter charts..\n4. Photopic and mesopic contrast sensitivity in central vision, as measured by letter charts..\n5. 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).\n6. 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).\n7. Questionnaires: Demographics, medical co-morbidities, cognitive status screen, medication use, alcohol use, smoking, self-reported visual difficulty in the visual activities of daily living\n\nThe Young normal group will only complete:\n\n1. Rod-mediated dark adaptation (RMDA), the ability to recover light sensitivity after exposure to a bright light.\n2. Dark-adapted two-color microperimetry, a measure of light sensitivity for lights of two different colors.\n3. . Photopic and mesopic acuity in central vision, as measured by letter charts..\n4. Photopic and mesopic contrast sensitivity in central vision, as measured by letter charts..\n5. 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor 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.\n\nExclusion Criteria:\n\nExclusion for those in normal macular health are:\n\n* ANY EYE CONDITION OR DISEASE IN EITHER EITHER (OTHER THAN EARLY CATARACT) THAT CAN IMPAIR VISION INCLUDING:\n* diabetic retinopathy\n* glaucoma\n* ocular hypertension\n* history of retinal diseases (e.g., retinal vein occlusion, retinal degenerations)\n* optic neuritis\n* corneal disease\n* previous ocular trauma or surgery\n* REFRACTIVE ERROR \\>- 6 DIOPTERS\n* NEUROLOGICAL CONDITIONS THAT CAN IMPAIR VISION OR JUDGEMENT INCLUDING:\n* multiple sclerosis\n* Parkinson disease\n* stroke\n* Alzheimer disease\n* seizure disorders\n* brain tumor\n* traumatic brain injury\n* PSYCHIATRIC DISORDERS THAT COULD IMPAIR THE ABILITY:\n* to follow simple directions\n* answer questions about health and functioning\n* or to provide informed consent\n* DIABETES\n* ANY MEDICAL CONDITION THAT CAUSES SIGNIFICANT FRALITY OR IS BELIEVED TO BE TERMINAL.\n\nExclusion criteria for the early AMD group:\n\nThese 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.\n\nExclusion for Young Normals:\n\n* ANY EYE CONDITION OR DISEASE IN EITHER EYE (OTHER THAN EARLY CATARACT) THAT CAN IMPAIR VISION INCLUDING:\n* diabetic retinopathy\n* glaucoma\n* ocular hypertension\n* history of retinal diseases (e.g., retinal vein occlusion, retinal degenerations)\n* optic neuritis, corneal disease\n* previous ocular trauma or surgery\n* RERACTIVE ERROR \\>=6 DIOPTORS\n* NEUROLOGICAL CONDITIONS THAT CAN IMPAIR VISION OR JUDGEMENT INCLUDING:\n* multiple sclerosis\n* Parkinson disease\n* stroke\n* Alzheimer disease\n* seizure disorders\n* brain tumor\n* traumatic brain injury\n* PSYCHIATRIC DISORDERS THAT COULD IMPAIR THE ABILITY TO:\n* follow simple directions\n* answer questions about health and functioning\n* or to provide informed consent\n* DIABETES\n* ANY MEDICAL CONDITION THAT CAUSES SIGNIFICANT FRAILTY OR IS BELIEVED TO BE TERMINAL.'}, 'identificationModule': {'nctId': 'NCT04112667', 'acronym': 'ALSTAR2', 'briefTitle': 'Functionally Validated Structural Endpoints for Early AMD', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Functionally Validated Structural Endpoints for Early AMD', 'orgStudyIdInfo': {'id': 'IRB-300003067'}, 'secondaryIdInfos': [{'id': '1R01EY029595', 'link': 'https://reporter.nih.gov/quickSearch/1R01EY029595', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal Macular Health', 'description': '\\>=60 years old with no macular disease', 'interventionNames': ['Other: Normal Macular Health']}, {'label': 'Early Macular Degeneration', 'description': '\\>=60 years old with early age-related macular degeneration', 'interventionNames': ['Other: Early Macular Degeneration']}, {'label': 'Young Normals', 'description': '20-30 years old with normal macular health', 'interventionNames': ['Other: Young Normals']}], 'interventions': [{'name': 'Normal Macular Health', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Normal Macular Health']}, {'name': 'Early Macular Degeneration', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Early Macular Degeneration']}, {'name': 'Young Normals', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Young Normals']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Currently there is no plan to make individual participant data available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cynthia Owsley', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Eye Institute (NEI)', 'class': 'NIH'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Ophthalmology and Visual Sciences', 'investigatorFullName': 'Cynthia Owsley', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}