Imaging Comparison for Age-Related Macular Degeneration

(COCO-GA Trial)

Overseen By Angie Adler

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Neovascular AMD, Media opacity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which imaging device best measures the size of geographic atrophy (GA), a type of eye damage caused by age-related macular degeneration (AMD). Participants will undergo eye scans using various imaging tools, including Optos imaging, Spectralis FAF imaging, and Zeiss Clarus 700 imaging, to identify which aligns with current standard practices. The trial suits those with GA due to AMD who are patients at the University Station Eye Clinic. Participants will spend about an hour to an hour and fifteen minutes undergoing the tests. As an unphased trial, this study allows participants to contribute to advancing eye care technology and improving diagnostic accuracy.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these imaging devices are safe for patients with geographic atrophy?

Research has shown that the imaging methods used in this trial, such as Spectralis FAF imaging, have been safely applied in other studies for age-related macular degeneration (AMD). These techniques allow doctors to assess the retina's condition without causing harm to patients. Spectralis FAF imaging and similar methods are non-invasive, meaning they do not physically enter the body, making them generally safe and easy for patients to tolerate.

Existing research reports no major negative effects from these imaging methods. Since the trial focuses on comparing images rather than testing a new drug or treatment, safety concerns remain minimal. Participants will be involved in the study for a short duration, about 60-75 minutes, which further reduces the risk of any potential side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores advanced imaging techniques for age-related macular degeneration, a leading cause of vision loss. Unlike traditional imaging methods, Optos imaging, Spectralis FAF imaging, and Zeiss Clarus 700 imaging provide high-resolution images that can offer more detailed insights into the condition of the retina. These advanced imaging methods may help in early detection and more precise monitoring of disease progression, potentially leading to better-tailored treatments for patients. By comparing these imaging techniques, researchers aim to identify the most effective method for assessing and managing age-related macular degeneration.

What evidence suggests that these imaging devices are effective for measuring geographic atrophy?

Research shows that Spectralis FAF imaging, which participants in this trial may receive, effectively highlights patterns of age-related macular degeneration (AMD). Studies have found that FAF imaging reveals important details in the eyes that enhance understanding of AMD. This includes detecting changes in the retina, often before they become visible with other imaging methods. For people with AMD, FAF imaging identifies specific changes in the eye and tracks the condition's progression over time. These capabilities suggest that Spectralis FAF imaging is a valuable tool for managing AMD. ^{6 7 8 9 10}

Who Is on the Research Team?

Amitha Domalpally, MD, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for individuals over 50 with a specific eye condition called geographic atrophy due to age-related macular degeneration. Participants should have GA areas between 1.25 and 23 mm², which can be either subfoveal or extrafoveal. Those with neovascular AMD, other retinal diseases that could affect the study, or who cannot undergo eye imaging are not eligible.

Inclusion Criteria

My eye condition affects a specific area size and can be in one or more spots.

I have been diagnosed with geographic atrophy due to age-related macular degeneration.

Willing to participate as evidenced by signing the written informed consent

Exclusion Criteria

Unable to tolerate opthalmic imaging

My eye doctor confirmed I have wet AMD.

Presence of significant media opacity preventing adequate retinal imaging

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Imaging

Participants undergo dilated fundus exam and imaging using Optos and Zeiss Clarus ultrawide field FAF, as well as Spectralis AF imaging

60-75 minutes

1 visit (in-person)

Follow-up

Participants are monitored for any immediate reactions post-imaging and data is analyzed

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Optos imaging
• Spectralis FAF imaging
• Zeiss Clarus 700 imaging

Trial Overview The trial aims to compare three different eye imaging systems: Spectralis FAF, Optos, and Zeiss Clarus 700. It will determine which system's measurements of geographic atrophy area align most closely with the standard care device in patients visiting University Station Eye Clinic.

How Is the Trial Designed?

Group I: Fundus autofluorescence (FAF) imaging Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Published Research Related to This Trial

In a study of 50 patients with intermediate age-related macular degeneration, ultrawidefield (UWF) retinal imaging detected hyperpigmentary changes in 100% of cases, compared to 93% with conventional color fundus photography (CFP), highlighting UWF's superior efficacy.

UWF imaging not only identified more hyperpigmentation but also provided a significantly larger area measurement of these changes compared to CFP, indicating its potential for better monitoring and assessment of macular degeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ULTRAWIDEFIELD PSEUDOCOLOR RETINAL IMAGING VERSUS REAL-COLOR FUNDUS PHOTOGRAPHY FOR DETECTION OF INTRARETINAL PIGMENT MIGRATION IN AGE-RELATED MACULAR DEGENERATION. Ramtohul, P., Gascon, P., Comet, A., et al.[2021]

Advancements in retinal imaging, particularly fundus autofluorescence and high-resolution optical coherence tomography, have greatly improved the understanding of geographic atrophy (GA) in age-related macular degeneration, allowing for better identification and measurement of disease progression.

Currently, there is no available therapy to slow or stop GA, highlighting the importance of precise quantification of GA progression for future interventional trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging geographic atrophy in age-related macular degeneration. Göbel, AP., Fleckenstein, M., Schmitz-Valckenberg, S., et al.[2022]

In a study involving 157 patients with diabetes, the UWF Clarus fundus imaging method demonstrated superior performance in detecting early diabetic retinopathy (DR) lesions compared to conventional five-field and UWF Optos imaging methods.

The agreement in DR severity grading was significantly higher between the five-field method and covered Clarus images, indicating that Clarus imaging is more effective for assessing early DR severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of early diabetic retinopathy severity using ultra-widefield Clarus versus conventional five-field and ultra-widefield Optos fundus imaging. Xiao, Y., Dan, H., Du, X., et al.[2023]

A new grading model for autofluorescence images (AF) in patients with age-related macular degeneration (ARMD) showed excellent inter-observer reliability, particularly for classifying choroidal neovascularization (CNV) and correlating AF patterns with visual acuity outcomes.

The study involved 71 eyes from 54 patients and found that certain AF patterns could predict visual acuity outcomes better than traditional fluorescein angiography (FFA), suggesting that this grading model could enhance the evaluation of imaging techniques in clinical and research settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined grading for choroidal neovascularisation: colour, fluorescein angiography and autofluorescence images. Vujosevic, S., Vaclavik, V., Bird, AC., et al.[2018]

In a study involving 30 eyes from 15 patients with mild dry age-related macular degeneration (AMD) and 15 healthy patients, the topographic map analysis of autofluorescence images showed the highest sensitivity (83-92%) and specificity (87-93%) for detecting AMD changes.

The 3D display of optical density, while visually appealing, was found to be less effective for analysis, with lower sensitivity (58-83%) and specificity (53-60%), indicating that topographic mapping is the preferred method for evaluating autofluorescence images in AMD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Topographic, 3D and Quantitative analysis of autofluorescence in dry, age-related macular degeneration]. Strauss, RW., Kampik, A., Neubauer, AS.[2009]

In a study of 202 patients, UWF-Clarus fundus imaging demonstrated excellent agreement with the ETDRS severity scale for diagnosing diabetic retinopathy (DR), suggesting it could be a superior method for assessing DR severity compared to traditional methods.

UWF-Clarus imaging revealed significantly more peripheral lesions than UWF-Optos imaging, indicating that it may detect more severe cases of DR, with potential implications for improving diagnosis and treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of quantitative assessment and efficiency of diabetic retinopathy diagnosis using ETDRS seven-field imaging and two ultra-widefield imaging. Xiao, Y., Huang, Z., Yuan, Q., et al.[2023]

The Optos 200Tx imaging system captured a significantly larger total retinal area compared to the Heidelberg Spectralis, indicating its superior capability for visualizing both mid-peripheral and far-peripheral regions of the retina in a study involving 18 patients.

Statistical analysis showed that the Optos 200Tx provided larger images in all four quadrants of the retina, with significant differences noted, particularly in the inferior quadrant, suggesting it may offer better diagnostic potential in retinal imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance evaluation of two fundus oculi angiographic imaging system: Optos 200Tx and Heidelberg Spectralis. Li, S., Wang, JJ., Li, HY., et al.[2020]

Fundus autofluorescence imaging can effectively predict the rate of geographic atrophy (GA) progression in patients with age-related macular degeneration, using a simple categorical scheme based on the extent of hyperautofluorescence.

In a study of 45 subjects over an average follow-up of 18.5 months, different categories of baseline rim area focal hyperautofluorescence were associated with significantly different growth rates of GA, indicating that this imaging technique can help identify patients at risk for faster disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of fundus autofluorescence images to predict geographic atrophy progression. Bearelly, S., Khanifar, AA., Lederer, DE., et al.[2021]

The Optos(®) Optomap(®) imaging system captures a significantly larger total retinal area compared to the Heidelberg Spectralis(®) system, averaging 151,362 pixels versus 101,786 pixels, indicating its efficacy in providing a broader view of the retina.

While the Optos(®) system excels in imaging the nasal and temporal regions of the retina, the Heidelberg Spectralis(®) is better at capturing the superior and inferior retinal vasculature more peripherally, suggesting that both systems have unique strengths in retinal imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of ultra-widefield fluorescein angiography with the Heidelberg Spectralis(®) noncontact ultra-widefield module versus the Optos(®) Optomap(®). Witmer, MT., Parlitsis, G., Patel, S., et al.[2022]

The ClarusTM imaging system demonstrated a high sensitivity of 94.4% in detecting neovascular age-related macular degeneration (AMD), making it a superior tool compared to Optos® (81.1%) and digital fundus photographs (87.8%).

ClarusTM also showed strong specificity (89.5%), indicating it is effective not only in identifying AMD but also in correctly ruling out normal cases, which is crucial for early detection and timely treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensitivity and specificity of high-resolution wide field fundus imaging for detecting neovascular age-related macular degeneration. Maruyama-Inoue, M., Kitajima, Y., Mohamed, S., et al.[2020]

The Optos P200DTx fundus camera captured significantly more retinal pixels and a larger total retinal area compared to the Zeiss Clarus 500, with results showing 510.4 pixels versus 355.6 pixels and 765.6 mm² versus 566.5 mm² respectively, indicating its superior imaging capability.

Despite the differences in imaging performance, there was no significant preference between the two devices among patients and technicians, nor was there a notable difference in the average time taken for imaging sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative Comparison of Fundus Images by 2 Ultra-Widefield Fundus Cameras. Chen, A., Dang, S., Chung, MM., et al.[2022]

Citations

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