Geographic Atrophy From Age-related Macular DegenerationFCPGA-2025NCT07582042
Lesion-tailored, Fundus-controlled Perimetry in Geographic Atrophy (GA).
An observational study of Geographic Atrophy From Age-related Macular Degeneration, run by University of Utah at 1 site in United States.
Trial summary
The goal of this observational study is to evaluate changes in retinal sensitivity over time in patients with geographic atrophy due to age related macular degeneration who are receiving pegcetacoplan as part of routine clinical care. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Geographic Atrophy From Age-related Macular Degeneration
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2026to 1 Aug 2029
- 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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD) in at least one eye will be included who already receive pegcetacoplan intravitreally according to the approved label as part of their routine clinical care. The study does not assign treatment prospectively; pegcetacoplan is prescribed and administered as part of routine clinical care at the discretion of the treating physician.
Who may be able to join
- Age 65-90 years.
- Geographic Atrophy (GA) secondary to dry Age-related Macular Degeneration (AMD) in at least one eye with the following criteria:
- GA lesion size between 1 and 15 mm² (≈ 0.4 to 6 disc areas)
- GA borders must be at least 500 μm from the edge of the 30° × 25° optical coherence tomography (OCT) image frame
- No confluent GA extending into peripapillary atrophy
- Receiving intravitreal pegcetacoplan per label (at least one injection before screening).
Show all 9Show fewer
- Best-corrected visual acuity (BCVA) of 0.1 - 1.0 logMAR (≈ 20/20 to 20/200 Snellen)
- Able to undergo mesopic FCP and required imaging.
- Informed consent provided.
Who cannot join
- Currently or previously active exudative macular neovascularization in the study eye.
- High refractive errors (> ±5.00 Diopters [D] spherical equivalent) and significant astigmatism (> 2.50 D).
- Ocular comorbidities likely to confound sensitivity or imaging (e.g., diabetic retinopathy with macular edema, retinal vein occlusion (RVO), inherited retinal disease, uncontrolled glaucoma).
- Media opacity precluding reliable fundus-controlled perimetry (FCP) or imaging (e.g., dense cataract, corneal opacity, vitreous hemorrhage).
- Any systemic condition judged likely to compromise participation, follow-up, or data integrity.
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
University of Utah, Department of Ophthalmology, John A. Moran Eye Center
Salt Lake City, Utah, 84132
About this study
Official title: Integration of Lesion-tailored, Fundus-controlled Perimetry Into Routine Clinical Care for Patients With Geographic Atrophy (GA) Receiving Pegcetacoplan Treatment in Accordance With the Approved Label.
The goal of this observational study is to evaluate changes in retinal sensitivity over time in patients with geographic atrophy due to age related macular degeneration who are receiving pegcetacoplan as part of routine clinical care. The study aims to determine whether lesion tailored fundus-controlled perimetry can reliably measure functional changes near areas of atrophy and whether this testing can be implemented in everyday clinic care over 24 months. Participants will undergo repeated vision testing, standard eye imaging, and visual function questionnaires while continuing their prescribed treatment.
Read the detailed description
The study will prospectively recruit patients from the Retina Clinics at the John A. Moran Eye Center and its satellite clinics.
All team members will be trained and certified for their specific tasks to ensure that uniform procedures are followed in order to obtain comparable and reliable data.
The following study procedures will be performed after informed consent has been obtained (in chronologic order):
- Assessment of past and current ophthalmic history, and demographic details
- Best-corrected visual acuity (BCVA) for both eyes measured by Early Treatment Diabetic Retinopathy Study (ETDRS) or Snellen charts (performed at Visit [V]1, V2, V4 and V6)
- Fundus-controlled perimetry (FCP)
- Training Test (performed at V1, V2, V3, V4, V5, V6)
- Fixes macula pattern (performed at V1 and V6)
- Patient-tailored pattern (performed at V2 [twice for test - re-test assessment], V3, V4, V5, V6)
- Vision Impairment in Low Luminance with 33 items (VILL-33), a 33-item questionnaire (performed at V2, V4, and V6)
- Fundus autofluorescence (FAF), near infrared (NIR) and simultaneous spectral domain optical coherence tomography (SD-OCT) imaging (performed at V1, V4 and V6)
- Color digital fundus photographs (optional at visits V1, V4, and V6)
- OCT-angiography (OCT-A) imaging (optional at visits V1, V4 and V6)
Data to be obtained and analyzed will include each participant's medical and ophthalmic history, current medications, smoking history, body mass index (BMI), and demographic information. Additional research data will include records of any adverse events, functional testing results such as best-corrected visual acuity (BCVA) and fundus-controlled perimetry (FCP), and digital imaging data including color fundus photographs, fundus autofluorescence (FAF) images, near-infrared reflectance (NIR) images, optical coherence tomography (OCT) images, and optical coherence tomography angiography (OCT-A) images.
Study data and documentation will be monitored throughout the study to ensure accuracy, completeness, and compliance with the approved protocol, Good Clinical Practice (GCP) standards, and institutional policies. Monitoring procedures will include periodic review of informed consent documentation and verification that data recorded in study forms and electronic databases are consistent with source documents.
Data management and analysis will be conducted by the Utah Retinal Reading Center (UREAD). UREAD will develop comprehensive study-specific documentation, including a Data Management Manual and a Grading Manual, which will outline standardized protocols for data processing, grading procedures, and quality assurance.
Prior to initiating formal data analysis, all image graders will undergo standardized training and certification using curated training datasets. Each imaging dataset will be independently evaluated by two certified readers to ensure objectivity. In cases of disagreement, a senior grader will perform an arbitration review to determine the final grading outcome.
At the screening visit (V1), structural inclusion and exclusion criteria will be assessed to determine patient eligibility. The Reading Center will provide three types of FCP testing patterns in Extensible Markup Language (XML) format: Training Pattern; Fixed Central Macula Pattern; and a Patient-Tailored Pattern.
All imaging and test data will be securely transferred from the study site to UREAD for centralized grading and analysis. Quality control procedures will be implemented throughout the study to ensure data integrity and consistency.
What is being measured
The primary outcome is the main question the study is designed to answer.
Slope of mesopic retinal sensitivity decline (dB/year) at predefined distances from the Geographic Atrophy (GA) border.
Quantify rates of mesopic sensitivity decline over time at defined distances from the Geographic Atrophy (GA) boundary.
Measured: Duration per participant: 24 months (36-month total project timeline including start-up, ~6-month recruitment, and ~3-month close-out/analysis).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start15 Jun 2026
- Primary completion1 May 2029 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Geographic Atrophy From Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Apellis Pharmaceuticals, Inc.
- Responsible party
- Principal investigator, Monika Fleckenstein, University of Utah
- Investigators
- Monika Fleckenstein, MD, Principal investigator, University of Utah, Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582042
- Sponsor's protocol ID
- IRB_00197197
- Acronym
- FCPGA-2025
- Status last verified
- Jun 2026
- First submitted
- 5 May 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is a collaborative project with Apellis Pharmaceuticals. The data sharing is regulated in the Research Collaboration Agreement.
Publications
Heier 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 37865470Pfau M, Muller PL, von der Emde L, Lindner M, Moller PT, Fleckenstein M, Holz FG, Schmitz-Valckenberg S. MESOPIC AND DARK-ADAPTED TWO-COLOR FUNDUS-CONTROLLED PERIMETRY IN GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION. Retina. 2020 Jan;40(1):169-180. doi: 10.1097/IAE.0000000000002337.
PubMed 30300264Pfau M, Jolly JK, Wu Z, Denniss J, Lad EM, Guymer RH, Fleckenstein M, Holz FG, Schmitz-Valckenberg S. Fundus-controlled perimetry (microperimetry): Application as outcome measure in clinical trials. Prog Retin Eye Res. 2021 May;82:100907. doi: 10.1016/j.preteyeres.2020.100907. Epub 2020 Oct 3.
PubMed 33022378Fleckenstein M, Schmitz-Valckenberg S, Chakravarthy U. Age-Related Macular Degeneration: A Review. JAMA. 2024 Jan 9;331(2):147-157. doi: 10.1001/jama.2023.26074.
PubMed 38193957
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Lesion-tailored, Fundus-controlled Perimetry Into Routine Clinical Care for Patients With Geographic Atrophy (GA) Receiving Pegcetacoplan Treatment in Accordance With the Approved Label.
- ClinicalTrials.gov ID
- NCT07582042
- Acronym / sponsor ID
- FCPGA-2025 / IRB_00197197
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Apellis Pharmaceuticals, Inc.
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 12 May 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 goal of this observational study is to evaluate changes in retinal sensitivity over time in patients with geographic atrophy due to age related macular degeneration who are receiving pegcetacoplan as part of routine clinical care. The study aims to determine whether lesion tailored fundus-controlled perimetry can reliably measure functional changes near areas of atrophy and whether this testing can be implemented in everyday clinic care over 24 months. Participants will undergo repeated vision testing, standard eye imaging, and visual function questionnaires while continuing their prescribed treatment.
Detailed description
The study will prospectively recruit patients from the Retina Clinics at the John A. Moran Eye Center and its satellite clinics.
All team members will be trained and certified for their specific tasks to ensure that uniform procedures are followed in order to obtain comparable and reliable data.
The following study procedures will be performed after informed consent has been obtained (in chronologic order):
- Assessment of past and current ophthalmic history, and demographic details
- Best-corrected visual acuity (BCVA) for both eyes measured by Early Treatment Diabetic Retinopathy Study (ETDRS) or Snellen charts (performed at Visit [V]1, V2, V4 and V6)
- Fundus-controlled perimetry (FCP)
- Training Test (performed at V1, V2, V3, V4, V5, V6)
- Fixes macula pattern (performed at V1 and V6)
- Patient-tailored pattern (performed at V2 [twice for test - re-test assessment], V3, V4, V5, V6)
- Vision Impairment in Low Luminance with 33 items (VILL-33), a 33-item questionnaire (performed at V2, V4, and V6)
- Fundus autofluorescence (FAF), near infrared (NIR) and simultaneous spectral domain optical coherence tomography (SD-OCT) imaging (performed at V1, V4 and V6)
- Color digital fundus photographs (optional at visits V1, V4, and V6)
- OCT-angiography (OCT-A) imaging (optional at visits V1, V4 and V6)
Data to be obtained and analyzed will include each participant's medical and ophthalmic history, current medications, smoking history, body mass index (BMI), and demographic information. Additional research data will include records of any adverse events, functional testing results such as best-corrected visual acuity (BCVA) and fundus-controlled perimetry (FCP), and digital imaging data including color fundus photographs, fundus autofluorescence (FAF) images, near-infrared reflectance (NIR) images, optical coherence tomography (OCT) images, and optical coherence tomography angiography (OCT-A) images.
Study data and documentation will be monitored throughout the study to ensure accuracy, completeness, and compliance with the approved protocol, Good Clinical Practice (GCP) standards, and institutional policies. Monitoring procedures will include periodic review of informed consent documentation and verification that data recorded in study forms and electronic databases are consistent with source documents.
Data management and analysis will be conducted by the Utah Retinal Reading Center (UREAD). UREAD will develop comprehensive study-specific documentation, including a Data Management Manual and a Grading Manual, which will outline standardized protocols for data processing, grading procedures, and quality assurance.
Prior to initiating formal data analysis, all image graders will undergo standardized training and certification using curated training datasets. Each imaging dataset will be independently evaluated by two certified readers to ensure objectivity. In cases of disagreement, a senior grader will perform an arbitration review to determine the final grading outcome.
At the screening visit (V1), structural inclusion and exclusion criteria will be assessed to determine patient eligibility. The Reading Center will provide three types of FCP testing patterns in Extensible Markup Language (XML) format: Training Pattern; Fixed Central Macula Pattern; and a Patient-Tailored Pattern.
All imaging and test data will be securely transferred from the study site to UREAD for centralized grading and analysis. Quality control procedures will be implemented throughout the study to ensure data integrity and consistency.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD) in at least one eye will be included who already receive pegcetacoplan intravitreally according to the approved label as part of their routine clinical care. The study does not assign treatment prospectively; pegcetacoplan is prescribed and administered as part of routine clinical care at the discretion of the treating physician.
Key inclusion criteria (9 listed)
- Age 65-90 years.
- Geographic Atrophy (GA) secondary to dry Age-related Macular Degeneration (AMD) in at least one eye with the following criteria:
- Receiving intravitreal pegcetacoplan per label (at least one injection before screening).
- Best-corrected visual acuity (BCVA) of 0.1 - 1.0 logMAR (≈ 20/20 to 20/200 Snellen)
- Able to undergo mesopic FCP and required imaging.
Key exclusion criteria (5 listed)
- Currently or previously active exudative macular neovascularization in the study eye.
- High refractive errors (> ±5.00 Diopters [D] spherical equivalent) and significant astigmatism (> 2.50 D).
- Ocular comorbidities likely to confound sensitivity or imaging (e.g., diabetic retinopathy with macular edema, retinal vein occlusion (RVO), inherited retinal disease, uncontrolled glaucoma).
- Media opacity precluding reliable fundus-controlled perimetry (FCP) or imaging (e.g., dense cataract, corneal opacity, vitreous hemorrhage).
- Any systemic condition judged likely to compromise participation, follow-up, or data integrity.
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
Slope of mesopic retinal sensitivity decline (dB/year) at predefined distances from the Geographic Atrophy (GA) border.
Time frame: Duration per participant: 24 months (36-month total project timeline including start-up, ~6-month recruitment, and ~3-month close-out/analysis).
Quantify rates of mesopic sensitivity decline over time at defined distances from the Geographic Atrophy (GA) boundary.
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 17 Jun 2026.
- 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 30300264Pfau M, Muller PL, von der Emde L, Lindner M, Moller PT, Fleckenstein M, Holz FG, Schmitz-Valckenberg S. MESOPIC AND DARK-ADAPTED TWO-COLOR FUNDUS-CONTROLLED PERIMETRY IN GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION. Retina. 2020 Jan;40(1):169-180. doi: 10.1097/IAE.0000000000002337.
- Background: PubMed 33022378Pfau M, Jolly JK, Wu Z, Denniss J, Lad EM, Guymer RH, Fleckenstein M, Holz FG, Schmitz-Valckenberg S. Fundus-controlled perimetry (microperimetry): Application as outcome measure in clinical trials. Prog Retin Eye Res. 2021 May;82:100907. doi: 10.1016/j.preteyeres.2020.100907. Epub 2020 Oct 3.
- Background: PubMed 38193957Fleckenstein M, Schmitz-Valckenberg S, Chakravarthy U. Age-Related Macular Degeneration: A Review. JAMA. 2024 Jan 9;331(2):147-157. doi: 10.1001/jama.2023.26074.
- Individual participant dataSharing planned: Undecided. This is a collaborative project with Apellis Pharmaceuticals. The data sharing is regulated in the Research Collaboration Agreement.
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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.
Monika Fleckenstein, MD principal investigator
University of Utah, Department of Ophthalmology
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 Geographic Atrophy From Age-related Macular Degeneration, run by University of Utah 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 9 inclusion and 5 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 17 Jun 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 Jenny Mireles (+1 ext. 801-585-5285, jenny.mireles@utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Slope of mesopic retinal sensitivity decline (dB/year) at predefined distances from the Geographic Atrophy (GA) border. (time frame: Duration per participant: 24 months (36-month total project timeline including start-up, ~6-month recruitment, and ~3-month close-out/analysis).). 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 NCT07582042, which also lists 4 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 17 Jun 2026.