Geographic AtrophyNCT07747662
Adaptive Optics Scanning Light Ophthalmoscopy (AOSLO) and Microperimetry (MP) Sub-study
A study testing Adaptive Optics Scanning Light Ophthalmoscopy, Microperimetry and Optical Coherence Tomography in people with Geographic Atrophy, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This research sub-study is to evaluate if combining images from Optical Coherence Tomography (OCT) scans with Adaptive Optics Scanning Light Ophthalmoscopy (AOSLO) and Microperimetry (MP) could show a link between structural changes in the back of the eye and vision. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Geographic Atrophy
- What is being tested?
- Adaptive Optics Scanning Light Ophthalmoscopy, Microperimetry and Optical Coherence Tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50 years or older and may be either male or female and may be of any race
- Established diagnosis of geographic atrophy (GA) due to age-related macular degeneration (AMD)
- GA characteristics: GA area of between 1.25 mm² and 23 mm², with seventy percent of eyes having GA area ranging from 2.5 mm² to 17.5 mm². GA may be unifocal or multifocal. GA may be subfoveal or extrafoveal, with twenty-five percent of eyes having subfoveal GA. The presence of concurrent peripapillary atrophy will not exclude participants from participation
- Willing to participate as evidenced by signing the written informed consent
- Additional Sub-study Inclusion Criteria:
- Early-stage GA defined as
Show all 11Show fewer
- GA area of between 1.25 mm2 and 23 mm2
- GA may be unifocal or multifocal
- GA may be subfoveal or extrafoveal
- Concurrent peripapillary atrophy will not exclude participant from participation
- Phakic and pseudophakic participants are eligible for enrollment, with phakic participants prioritized when feasible.
Who cannot join
- Unable to tolerate ophthalmic imaging
- Presence of neovascular AMD on optical coherence tomography (OCT) as confirmed by an ophthalmologist
- Presence of significant media opacity preventing adequate retinal imaging
- Presence of concurrent retinal disease which may confound assessment
- Additional Sub-study Exclusion Criteria:
- Ocular media opacity or other condition(s) that, in the opinion of the investigators, may preclude imaging.
- Individuals who, in the opinion of the investigator, are unable to tolerate study procedures or comply with study requirements.
- Prior or current treatment with intraocular injections for geographic atrophy (e.g., pegcetacoplan [Syfovre] or similar therapies) is not permitted.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Structure and Function in the Progression of Atrophic AMD: Validation of Photoreceptor Damage Observed With OCT Using AOSLO (Adaptive Optics Scanning Light Ophthalmoscopy and Microperimetry
This research sub-study is to evaluate if combining images from Optical Coherence Tomography (OCT) scans with Adaptive Optics Scanning Light Ophthalmoscopy (AOSLO) and Microperimetry (MP) could show a link between structural changes in the back of the eye and vision. 10 participants that were enrolled in the COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Geographic Atrophy study [NCT05961332] will be approached to enroll. Participants may complete OCT imaging and initial assessments during an initial visit and may return for additional procedures, including microperimetry and AOSLO imaging, within a window of up to 4 weeks.
Read the detailed description
Age-related macular degeneration (AMD) is a leading cause of blindness worldwide, with geographic atrophy (GA) representing the advanced, untreatable form of the disease. GA leads to progressive degeneration of retinal cells critical for vision, resulting in irreversible vision loss and a significant impact on patients' quality of life. Despite the prevalence of GA, treatment options remain limited. Current therapeutic strategies focus on slowing the enlargement of atrophic regions, but clinical trials have faced challenges in demonstrating clear patient benefits.
In clinical practice, GA progression is often evaluated by measuring the area of atrophy on retinal imaging, such as fundus autofluorescence (FAF) and, more recently, optical coherence tomography (OCT). These structural biomarkers are used in clinical trials to assess the efficacy of new drugs, with the FDA accepting a reduction in the rate of GA enlargement as a successful outcome. However, these structural metrics often fail to correlate with functional vision loss, leaving patients and physicians disappointed by treatments that may stabilize GA progression without improving their visual outcomes.
The ellipsoid zone (EZ), a hyperreflective layer visualized on OCT, represents the structural integrity of photoreceptors-cells responsible for converting light into visual signals. In patients with one or more GA lesions, OCT imaging shows that the EZ is typically absent within the GA, while the EZ in the perilesional zone may be attenuated or damaged. Perilesional EZ loss is thought to represent the area at highest risk for future vision loss. With the FDA approval of photoreceptor preservation as an endpoint for GA trials, there has been significant interest in measuring EZ loss from OCT scans. Drug approval will now focus on the prevention of EZ loss in the perilesional areas rather than GA area expansion. However, it is important to establish whether the absence of the EZ truly indicates photoreceptor damage and whether there is a functional correlation between EZ loss and visual sensitivity. Adaptive Optics and microperimetry are two modalities that can help address this.
This sub-study is a pilot comparative imaging study. In addition to the imaging procedures collected for the main COCO GA study [NCT05961332], participants will have the following study images obtained:
- Spectralis OCT (if applicable),
- visual acuity,
- ocular biometry, which is a non-invasive eye test using a machine called an IOL master,
- microperimetry, and
- Adaptive Optics Scanning Light Ophthalmoscopy (AOSLO)
- Conditions
- Geographic Atrophy
- Being tested
- Adaptive Optics Scanning Light Ophthalmoscopy, Microperimetry, Optical Coherence Tomography
- Medical subject headings
- Geographic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Optics Scanning Light OphthalmoscopyDevice
Also called AOSLO
AOSLO imaging offers unprecedented resolution by correcting optical distortions, enabling direct visualization of individual photoreceptors. The procedure takes 60 minutes.
MicroperimetryDevice
Microperimetry measures retinal sensitivity at specific retinal locations while tracking eye movements, enabling precise correlation with structural changes. The procedure takes up to 45 minutes.
Optical Coherence TomographyDevice
Also called OCT
OCT will be performed using the Heidelberg Spectralis system with a high-resolution scanning protocol. This is a repeat procedure, the first image was obtained in the main study. The procedure takes 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Microperimetry, Optical Coherence Tomography, Adaptive Optics | Experimental | Imaging procedures may be completed during a single study visit or across two study visits based on participant availability and operational workflow. When procedures occur across two visits, OCT imaging will be performed first to allow WRC review prior to scheduling microperimetry and AOSLO imaging. If all procedures are completed during a single visit, the total visit time is approximately 5-6 hours. If a second study visit is needed, only the remaining study procedures will be completed, so the second visit will be shorter since the initial ophthalmic procedures have already been performed. Receives: Device: Adaptive Optics Scanning Light Ophthalmoscopy; Device: Microperimetry; Device: Optical Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Photoreceptors in EZ absent regions
The aim is to validate the use of AOSLO imaging for OCT-based EZ classifications, directly visualizing photoreceptor mosaics and correlating EZ loss with photoreceptor structure.
Semi-automated machine learning algorithms will be used to segment the EZ layer on OCT images and generate en face maps. All algorithm outputs will be reviewed and verified by trained human graders.
AOSLO imaging will validate these maps by providing photoreceptor cell counts and qualitative assessments in the same region
Measured: up to 6 hours total during one or two study visits
Area of EZ absent regions on AOSLO vs OCT imaging
The aim is to validate the use of AOSLO imaging for OCT-based EZ classifications, directly visualizing photoreceptor mosaics and correlating EZ loss with photoreceptor structure.
Semi-automated machine learning algorithms will be used to segment the EZ layer on OCT images and generate en face maps. All algorithm outputs will be reviewed and verified by trained human graders.
Graders will independently measure area of EZ loss from images of each device. The measurements (in mm²) will be compared between the two devices.
Measured: up to 6 hours total during one or two study visits
Correlation of Retinal Sensitivity Data with EZ Status
The aim is to correlate structural metrics (EZ status from OCT and AOSLO) with functional data (microperimetry), establishing EZ loss as a reliable biomarker for vision loss.
Measured: up to 6 hours total during one or two study visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start5 Nov 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geographic AtrophyStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amitha Domalpally, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747662
- Sponsor's protocol ID
- 2023-0958 Sub-study
- Other IDs
- Protocol Version 4/20/2026, SMPH/OPHTHAL&VIS SCI/FPRC
- Status last verified
- Oct 2026
- First submitted
- 30 Jul 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structure and Function in the Progression of Atrophic AMD: Validation of Photoreceptor Damage Observed With OCT Using AOSLO (Adaptive Optics Scanning Light Ophthalmoscopy and Microperimetry
- ClinicalTrials.gov ID
- NCT07747662
- Acronym / sponsor ID
- 2023-0958 Sub-study
- Conditions
- Geographic Atrophy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 5 Nov 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 5 Aug 2026 (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.
This research sub-study is to evaluate if combining images from Optical Coherence Tomography (OCT) scans with Adaptive Optics Scanning Light Ophthalmoscopy (AOSLO) and Microperimetry (MP) could show a link between structural changes in the back of the eye and vision. 10 participants that were enrolled in the COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Geographic Atrophy study [NCT05961332] will be approached to enroll. Participants may complete OCT imaging and initial assessments during an initial visit and may return for additional procedures, including microperimetry and AOSLO imaging, within a window of up to 4 weeks.
Detailed description
Age-related macular degeneration (AMD) is a leading cause of blindness worldwide, with geographic atrophy (GA) representing the advanced, untreatable form of the disease. GA leads to progressive degeneration of retinal cells critical for vision, resulting in irreversible vision loss and a significant impact on patients' quality of life. Despite the prevalence of GA, treatment options remain limited. Current therapeutic strategies focus on slowing the enlargement of atrophic regions, but clinical trials have faced challenges in demonstrating clear patient benefits.
In clinical practice, GA progression is often evaluated by measuring the area of atrophy on retinal imaging, such as fundus autofluorescence (FAF) and, more recently, optical coherence tomography (OCT). These structural biomarkers are used in clinical trials to assess the efficacy of new drugs, with the FDA accepting a reduction in the rate of GA enlargement as a successful outcome. However, these structural metrics often fail to correlate with functional vision loss, leaving patients and physicians disappointed by treatments that may stabilize GA progression without improving their visual outcomes.
The ellipsoid zone (EZ), a hyperreflective layer visualized on OCT, represents the structural integrity of photoreceptors-cells responsible for converting light into visual signals. In patients with one or more GA lesions, OCT imaging shows that the EZ is typically absent within the GA, while the EZ in the perilesional zone may be attenuated or damaged. Perilesional EZ loss is thought to represent the area at highest risk for future vision loss. With the FDA approval of photoreceptor preservation as an endpoint for GA trials, there has been significant interest in measuring EZ loss from OCT scans. Drug approval will now focus on the prevention of EZ loss in the perilesional areas rather than GA area expansion. However, it is important to establish whether the absence of the EZ truly indicates photoreceptor damage and whether there is a functional correlation between EZ loss and visual sensitivity. Adaptive Optics and microperimetry are two modalities that can help address this.
This sub-study is a pilot comparative imaging study. In addition to the imaging procedures collected for the main COCO GA study [NCT05961332], participants will have the following study images obtained:
- Spectralis OCT (if applicable),
- visual acuity,
- ocular biometry, which is a non-invasive eye test using a machine called an IOL master,
- microperimetry, and
- Adaptive Optics Scanning Light Ophthalmoscopy (AOSLO)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microperimetry, Optical Coherence Tomography, Adaptive Optics | Experimental | Device: Adaptive Optics Scanning Light Ophthalmoscopy, Device: Microperimetry, Device: Optical Coherence TomographyImaging procedures may be completed during a single study visit or across two study visits based on participant availability and operational workflow. When procedures occur across two visits, OCT imaging will be performed first to allow WRC review prior to scheduling microperimetry and AOSLO imaging. If all procedures are completed during a single visit, the total visit time is approximately 5-6 hours. If a second study visit is needed, only the remaining study procedures will be completed, so the second visit will be shorter since the initial ophthalmic procedures have already been performed. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 50 years or older and may be either male or female and may be of any race
- Established diagnosis of geographic atrophy (GA) due to age-related macular degeneration (AMD)
- GA characteristics: GA area of between 1.25 mm² and 23 mm², with seventy percent of eyes having GA area ranging from 2.5 mm² to 17.5 mm². GA may be unifocal or multifocal. GA may be subfoveal or extrafoveal, with twenty-five percent of eyes having subfoveal GA. The presence of concurrent peripapillary atrophy will not exclude participants from participation
- Willing to participate as evidenced by signing the written informed consent
- Early-stage GA defined as
Key exclusion criteria (8 listed)
- Unable to tolerate ophthalmic imaging
- Presence of neovascular AMD on optical coherence tomography (OCT) as confirmed by an ophthalmologist
- Presence of significant media opacity preventing adequate retinal imaging
- Presence of concurrent retinal disease which may confound assessment
- Ocular media opacity or other condition(s) that, in the opinion of the investigators, may preclude imaging.
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 |
|---|---|---|
| Adaptive Optics Scanning Light OphthalmoscopyAlso: AOSLOAOSLO imaging offers unprecedented resolution by correcting optical distortions, enabling direct visualization of individual photoreceptors. The procedure takes 60 minutes. | Device | Microperimetry, Optical Coherence Tomography, Adaptive Optics |
| MicroperimetryMicroperimetry measures retinal sensitivity at specific retinal locations while tracking eye movements, enabling precise correlation with structural changes. The procedure takes up to 45 minutes. | Device | Microperimetry, Optical Coherence Tomography, Adaptive Optics |
| Optical Coherence TomographyAlso: OCTOCT will be performed using the Heidelberg Spectralis system with a high-resolution scanning protocol. This is a repeat procedure, the first image was obtained in the main study. The procedure takes 5 minutes. | Device | Microperimetry, Optical Coherence Tomography, Adaptive Optics |
Primary outcome
Incidence of Photoreceptors in EZ absent regions
Time frame: up to 6 hours total during one or two study visits
The aim is to validate the use of AOSLO imaging for OCT-based EZ classifications, directly visualizing photoreceptor mosaics and correlating EZ loss with photoreceptor structure. Semi-automated machine learning algorithms will be used to segment the EZ layer on OCT images and generate en face maps. All algorithm outputs will be reviewed and verified by trained human graders. AOSLO imaging will validate these maps by providing photoreceptor cell counts and qualitative assessments in the same region
Area of EZ absent regions on AOSLO vs OCT imaging
Time frame: up to 6 hours total during one or two study visits
The aim is to validate the use of AOSLO imaging for OCT-based EZ classifications, directly visualizing photoreceptor mosaics and correlating EZ loss with photoreceptor structure. Semi-automated machine learning algorithms will be used to segment the EZ layer on OCT images and generate en face maps. All algorithm outputs will be reviewed and verified by trained human graders. Graders will independently measure area of EZ loss from images of each device. The measurements (in mm²) will be compared between the two devices.
Correlation of Retinal Sensitivity Data with EZ Status
Time frame: up to 6 hours total during one or two study visits
The aim is to correlate structural metrics (EZ status from OCT and AOSLO) with functional data (microperimetry), establishing EZ loss as a reliable biomarker for vision loss.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Geographic Atrophy (COCO-GA) main studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Geographic Atrophy
Active, not recruitingPhase 1/2
Phase 1/2 Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Age-Related Macular Degeneration, Geographic Atrophy
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingPhase 3
A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
Age-related Macular Degeneration (AMD), Geographic Atrophy (GA)
RecruitingPhase 1
Phase 1 Study of C.001 in Retinal Degeneration
Geographic Atrophy, Stargardt Disease
RecruitingPhase 2/3
A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Geographic Atrophy, 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.
Amitha Domalpally, MD, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Optics Scanning Light Ophthalmoscopy, Microperimetry and Optical Coherence Tomography in people with Geographic Atrophy, run by University of Wisconsin, Madison 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 8 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: enrolling by invitation, as of the sponsor's last update on 26 Oct 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of Photoreceptors in EZ absent regions (time frame: up to 6 hours total during one or two study visits). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2026.