Macular DegenerationNCT07798323
Noninvasive Imaging Biomarkers of Treatable Macrovascular Disease in Age-related Macular Degeneration.
An observational study of Macular Degeneration, run by Scott Raymond at 1 site in United States.
Trial summary
The purpose of this prospective study is to investigate whether ophthalmic artery stenosis (narrowing of the ophthalmic artery) contributes to the development and progression of geographic atrophy (GA), an advanced form of dry age-related macular degeneration (AMD). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Macular Degeneration
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to Dec 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This prospective study will enroll 30 patients from 50-80 years of age with geographic atrophy in one eye and mild to moderate AMD in the fellow eye according to International Classification of Disease (ICD) codes treated at the Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.
Who may be able to join
- 50-80 years of age
- All genders
- Asymmetric dry AMD with geographic atrophy in at least one eye and reduced disease severity in the other eye according to International Classification of Disease (ICD) codes
- Treated at the Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio
Who cannot join
- Poor image quality that limits quantification
- GA extending beyond the borders of the SDOCT field of view.
- Bilateral symmetric geographic atrophy.
- Diagnosis of wet AMD.
- Any retinal fluid at baseline.
- Other concurrent retinal diseases
Show all 9Show fewer
- Vitreoretinal surgery.
- Allergy to iodinated contrast agents.
- Chronic kidney disease with eGFR < 60
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Sara Lautzenhiser Research Coordinator, 216-444-3026, LAUTZES@ccf.org
Scott Raymond, MD
About this study
The purpose of this prospective study is to investigate whether ophthalmic artery stenosis (narrowing of the ophthalmic artery) contributes to the development and progression of geographic atrophy (GA), an advanced form of dry age-related macular degeneration (AMD).
- Conditions
- Macular Degeneration
- Medical subject headings
- Macular Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the ability to quantify ophthalmic artery stenosis using a commercially available, non-invasive imaging modality, PC-CTA.
Measured: From enrollment to the end of the 12-month study period.
Secondary outcomes (1)
To provide compelling evidence for a connection between ophthalmic artery stenosis and OCT markers of dry AMD disease severity and progression.
Measured: From enrollment to the end of the 12-month study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Sep 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for 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
- 30 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Scott Raymond
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Scott Raymond, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798323
- Sponsor's protocol ID
- 26-465
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Witkin AJ, Jaffe GJ, Srivastava SK, Davis JL, Kim JE. Retinal Vasculitis After Intravitreal Pegcetacoplan: Report From the ASRS Research and Safety in Therapeutics (ReST) Committee. J Vitreoretin Dis. 2023 Dec 21;8(1):9-20. doi: 10.1177/24741264231220224. eCollection 2024 Jan-Feb.
PubMed 38223782Spaide RF, Vavvas DG. COMPLEMENT INHIBITION FOR GEOGRAPHIC ATROPHY: Review of Salient Functional Outcomes and Perspective. Retina. 2023 Jul 1;43(7):1064-1069. doi: 10.1097/IAE.0000000000003796.
PubMed 36996460Heier JS, Lad EM, Holz FG, Rosenfeld PJ, Guymer RH, Boyer D, Grossi F, Baumal CR, Korobelnik JF, Slakter JS, Waheed NK, Metlapally R, Pearce I, Steinle N, Francone AA, Hu A, Lally DR, Deschatelets P, Francois C, Bliss C, Staurenghi G, Mones J, Singh RP, Ribeiro R, Wykoff CC; OAKS and DERBY study investigators. Pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration (OAKS and DERBY): two multicentre, randomised, double-masked, sham-controlled, phase 3 trials. Lancet. 2023 Oct 21;402(10411):1434-1448. doi: 10.1016/S0140-6736(23)01520-9.
PubMed 37865470Khanani AM, Patel SS, Staurenghi G, Tadayoni R, Danzig CJ, Eichenbaum DA, Hsu J, Wykoff CC, Heier JS, Lally DR, Mones J, Nielsen JS, Sheth VS, Kaiser PK, Clark J, Zhu L, Patel H, Tang J, Desai D, Jaffe GJ; GATHER2 trial investigators. Efficacy and safety of avacincaptad pegol in patients with geographic atrophy (GATHER2): 12-month results from a randomised, double-masked, phase 3 trial. Lancet. 2023 Oct 21;402(10411):1449-1458. doi: 10.1016/S0140-6736(23)01583-0. Epub 2023 Sep 8.
PubMed 37696275van Lookeren Campagne M, LeCouter J, Yaspan BL, Ye W. Mechanisms of age-related macular degeneration and therapeutic opportunities. J Pathol. 2014 Jan;232(2):151-64. doi: 10.1002/path.4266.
PubMed 24105633Mullins RF, Schoo DP, Sohn EH, Flamme-Wiese MJ, Workamelahu G, Johnston RM, Wang K, Tucker BA, Stone EM. The membrane attack complex in aging human choriocapillaris: relationship to macular degeneration and choroidal thinning. Am J Pathol. 2014 Nov;184(11):3142-53. doi: 10.1016/j.ajpath.2014.07.017. Epub 2014 Sep 7.
PubMed 25204844Biesemeier A, Taubitz T, Julien S, Yoeruek E, Schraermeyer U. Choriocapillaris breakdown precedes retinal degeneration in age-related macular degeneration. Neurobiol Aging. 2014 Nov;35(11):2562-2573. doi: 10.1016/j.neurobiolaging.2014.05.003. Epub 2014 May 10.
PubMed 24925811Gelfand BD, Ambati J. A Revised Hemodynamic Theory of Age-Related Macular Degeneration. Trends Mol Med. 2016 Aug;22(8):656-670. doi: 10.1016/j.molmed.2016.06.009. Epub 2016 Jul 13.
PubMed 27423265Friedman E. A hemodynamic model of the pathogenesis of age-related macular degeneration. Am J Ophthalmol. 1997 Nov;124(5):677-82. doi: 10.1016/s0002-9394(14)70906-7.
PubMed 9372722Farnsworth PJ, Campeau NG, Diehn FE, Yu L, Leng S, Zhou Z, Fletcher JG, McCollough CH. High-resolution computed tomography angiography of the orbit using a photon-counting computed tomography scanner. Interv Neuroradiol. 2025 Aug;31(4):539-554. doi: 10.1177/15910199231175198. Epub 2023 Jul 3.
PubMed 37401156Diprose WK, Wang MTM, Reidy J, Ma A, Brodie J, Steinfort B. Ophthalmic artery stenosis on three-dimensional rotational angiography: Interrater agreement, prevalence, and risk factors. Interv Neuroradiol. 2026 Aug;32(4):1267-1271. doi: 10.1177/15910199241233020. Epub 2024 Feb 22.
PubMed 38387875Nassisi M, Baghdasaryan E, Borrelli E, Ip M, Sadda SR. Choriocapillaris flow impairment surrounding geographic atrophy correlates with disease progression. PLoS One. 2019 Feb 22;14(2):e0212563. doi: 10.1371/journal.pone.0212563. eCollection 2019.
PubMed 30794627You QS, Camino A, Wang J, Guo Y, Flaxel CJ, Hwang TS, Huang D, Jia Y, Bailey ST. Geographic Atrophy Progression Is Associated With Choriocapillaris Flow Deficits Measured With Optical Coherence Tomographic Angiography. Invest Ophthalmol Vis Sci. 2021 Dec 1;62(15):28. doi: 10.1167/iovs.62.15.28.
PubMed 34964802Tiosano L, Corradetti G, Sadda SR. Progression of choriocapillaris flow deficits in clinically stable intermediate age-related macular degeneration. Eye (Lond). 2021 Nov;35(11):2991-2998. doi: 10.1038/s41433-020-01298-9. Epub 2021 Jan 7.
PubMed 33414537Alagorie AR, Verma A, Nassisi M, Sadda SR. Quantitative Assessment of Choriocapillaris Flow Deficits in Eyes with Advanced Age-Related Macular Degeneration Versus Healthy Eyes. Am J Ophthalmol. 2019 Sep;205:132-139. doi: 10.1016/j.ajo.2019.04.037. Epub 2019 May 10.
PubMed 31078531
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Imaging Biomarkers of Treatable Macrovascular Disease in Age-related Macular Degeneration.
- ClinicalTrials.gov ID
- NCT07798323
- Acronym / sponsor ID
- 26-465
- Conditions
- Macular Degeneration
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Scott RaymondUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 1 Sep 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.
The purpose of this prospective study is to investigate whether ophthalmic artery stenosis (narrowing of the ophthalmic artery) contributes to the development and progression of geographic atrophy (GA), an advanced form of dry age-related macular degeneration (AMD).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective study will enroll 30 patients from 50-80 years of age with geographic atrophy in one eye and mild to moderate AMD in the fellow eye according to International Classification of Disease (ICD) codes treated at the Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.
Key inclusion criteria (4 listed)
- 50-80 years of age
- All genders
- Asymmetric dry AMD with geographic atrophy in at least one eye and reduced disease severity in the other eye according to International Classification of Disease (ICD) codes
- Treated at the Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio
Key exclusion criteria (9 listed)
- Poor image quality that limits quantification
- GA extending beyond the borders of the SDOCT field of view.
- Bilateral symmetric geographic atrophy.
- Diagnosis of wet AMD.
- Any retinal fluid at baseline.
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
To demonstrate the ability to quantify ophthalmic artery stenosis using a commercially available, non-invasive imaging modality, PC-CTA.
Time frame: From enrollment to the end of the 12-month study period.
1 secondary outcome
To provide compelling evidence for a connection between ophthalmic artery stenosis and OCT markers of dry AMD disease severity and progression.
Time frame: From enrollment to the end of the 12-month study period.
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 3 Sep 2026.
- Background: PubMed 38223782Witkin AJ, Jaffe GJ, Srivastava SK, Davis JL, Kim JE. Retinal Vasculitis After Intravitreal Pegcetacoplan: Report From the ASRS Research and Safety in Therapeutics (ReST) Committee. J Vitreoretin Dis. 2023 Dec 21;8(1):9-20. doi: 10.1177/24741264231220224. eCollection 2024 Jan-Feb.
- Background: PubMed 36996460Spaide RF, Vavvas DG. COMPLEMENT INHIBITION FOR GEOGRAPHIC ATROPHY: Review of Salient Functional Outcomes and Perspective. Retina. 2023 Jul 1;43(7):1064-1069. doi: 10.1097/IAE.0000000000003796.
- Background: PubMed 37865470Heier JS, Lad EM, Holz FG, Rosenfeld PJ, Guymer RH, Boyer D, Grossi F, Baumal CR, Korobelnik JF, Slakter JS, Waheed NK, Metlapally R, Pearce I, Steinle N, Francone AA, Hu A, Lally DR, Deschatelets P, Francois C, Bliss C, Staurenghi G, Mones J, Singh RP, Ribeiro R, Wykoff CC; OAKS and DERBY study investigators. Pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration (OAKS and DERBY): two multicentre, randomised, double-masked, sham-controlled, phase 3 trials. Lancet. 2023 Oct 21;402(10411):1434-1448. doi: 10.1016/S0140-6736(23)01520-9.
- Background: PubMed 37696275Khanani AM, Patel SS, Staurenghi G, Tadayoni R, Danzig CJ, Eichenbaum DA, Hsu J, Wykoff CC, Heier JS, Lally DR, Mones J, Nielsen JS, Sheth VS, Kaiser PK, Clark J, Zhu L, Patel H, Tang J, Desai D, Jaffe GJ; GATHER2 trial investigators. Efficacy and safety of avacincaptad pegol in patients with geographic atrophy (GATHER2): 12-month results from a randomised, double-masked, phase 3 trial. Lancet. 2023 Oct 21;402(10411):1449-1458. doi: 10.1016/S0140-6736(23)01583-0. Epub 2023 Sep 8.
- Background: PubMed 24105633van Lookeren Campagne M, LeCouter J, Yaspan BL, Ye W. Mechanisms of age-related macular degeneration and therapeutic opportunities. J Pathol. 2014 Jan;232(2):151-64. doi: 10.1002/path.4266.
- Background: PubMed 25204844Mullins RF, Schoo DP, Sohn EH, Flamme-Wiese MJ, Workamelahu G, Johnston RM, Wang K, Tucker BA, Stone EM. The membrane attack complex in aging human choriocapillaris: relationship to macular degeneration and choroidal thinning. Am J Pathol. 2014 Nov;184(11):3142-53. doi: 10.1016/j.ajpath.2014.07.017. Epub 2014 Sep 7.
- Background: PubMed 24925811Biesemeier A, Taubitz T, Julien S, Yoeruek E, Schraermeyer U. Choriocapillaris breakdown precedes retinal degeneration in age-related macular degeneration. Neurobiol Aging. 2014 Nov;35(11):2562-2573. doi: 10.1016/j.neurobiolaging.2014.05.003. Epub 2014 May 10.
- Background: PubMed 27423265Gelfand BD, Ambati J. A Revised Hemodynamic Theory of Age-Related Macular Degeneration. Trends Mol Med. 2016 Aug;22(8):656-670. doi: 10.1016/j.molmed.2016.06.009. Epub 2016 Jul 13.
- Background: PubMed 9372722Friedman E. A hemodynamic model of the pathogenesis of age-related macular degeneration. Am J Ophthalmol. 1997 Nov;124(5):677-82. doi: 10.1016/s0002-9394(14)70906-7.
- Background: PubMed 37401156Farnsworth PJ, Campeau NG, Diehn FE, Yu L, Leng S, Zhou Z, Fletcher JG, McCollough CH. High-resolution computed tomography angiography of the orbit using a photon-counting computed tomography scanner. Interv Neuroradiol. 2025 Aug;31(4):539-554. doi: 10.1177/15910199231175198. Epub 2023 Jul 3.
- Background: PubMed 38387875Diprose WK, Wang MTM, Reidy J, Ma A, Brodie J, Steinfort B. Ophthalmic artery stenosis on three-dimensional rotational angiography: Interrater agreement, prevalence, and risk factors. Interv Neuroradiol. 2026 Aug;32(4):1267-1271. doi: 10.1177/15910199241233020. Epub 2024 Feb 22.
- Background: PubMed 30794627Nassisi M, Baghdasaryan E, Borrelli E, Ip M, Sadda SR. Choriocapillaris flow impairment surrounding geographic atrophy correlates with disease progression. PLoS One. 2019 Feb 22;14(2):e0212563. doi: 10.1371/journal.pone.0212563. eCollection 2019.
- Individual participant dataSharing planned: No
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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.
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 Macular Degeneration, run by Scott Raymond 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 3 Sep 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?
Contact Sara Lautzenhiser Research Coordinator (216-444-3026, LAUTZES@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate the ability to quantify ophthalmic artery stenosis using a commercially available, non-invasive imaging modality, PC-CTA. (time frame: From enrollment to the end of the 12-month study period.). 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 NCT07798323, which also lists 17 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 3 Sep 2026.