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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to compare measurements of geographic atrophy (GA) area between several types of imaging, in order to assess accuracy. The main question to answer is which imaging device provides measurements that are most similar to the standard of care device. Participants will be patients of a retina doctor at University Station Eye Clinic with geographic atrophy, and can expect to be in the study for 60-75 minutes.

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 data supports the idea that Imaging Comparison for Age-Related Macular Degeneration is an effective treatment?

The available research shows that the Clarus and Optos imaging systems are effective in detecting neovascular age-related macular degeneration (AMD) when compared to conventional digital fundus photographs. This suggests that these imaging methods can help in the early detection and management of AMD, which is crucial for effective treatment. While the studies also discuss the use of these imaging systems for diabetic retinopathy, the focus on AMD indicates their effectiveness in this specific condition. ^{1 2 3 4 5}

What data supports the effectiveness of this treatment for age-related macular degeneration?

The research shows that both the Clarus and Optos imaging systems are effective in detecting neovascular age-related macular degeneration (AMD) with high sensitivity and specificity, which means they are good at correctly identifying the condition and ruling it out when it's not present. ^{1 2 3 4 5}

What safety data exists for imaging methods used in age-related macular degeneration treatment?

The studies provided do not directly address safety data for the imaging methods used in age-related macular degeneration treatment. They focus on comparing the performance and effectiveness of different imaging systems, such as Optos and Clarus, in detecting retinal conditions like diabetic retinopathy and neovascular AMD. No specific safety concerns or adverse effects are mentioned in these studies. ^{1 2 3 4 6}

Is ultra-widefield imaging safe for humans?

The studies reviewed do not report any safety concerns related to the use of ultra-widefield imaging systems like Optos and Clarus for eye conditions, suggesting they are generally safe for human use. ^{1 2 3 4 6}

Is the treatment in the trial 'Imaging Comparison for Age-Related Macular Degeneration' a promising treatment?

The treatment in the trial is promising because it uses advanced imaging techniques to better understand and track the progression of age-related macular degeneration. This can help doctors predict how the disease will develop and potentially improve how they manage and treat it in the future. ^{7 8 9 10 11}

How does this treatment for age-related macular degeneration differ from other treatments?

This treatment is unique because it uses advanced imaging techniques like fundus autofluorescence to monitor and predict the progression of age-related macular degeneration, which helps in evaluating potential therapeutic effects, even though there is currently no therapy to halt the disease. ^{7 8 9 10 11}

Research Team

Amitha Domalpally, MD, PhD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Sensitivity and specificity of high-resolution wide field fundus imaging for detecting neovascular age-related macular degeneration. [2020]

2. England 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Quantitative Comparison of Fundus Images by 2 Ultra-Widefield Fundus Cameras. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Comparison of ultra-widefield fluorescein angiography with the Heidelberg Spectralis(®) noncontact ultra-widefield module versus the Optos(®) Optomap(®). [2022]

5. England 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. [2023]

6. Greece pubmed.ncbi.nlm.nih.gov

Performance evaluation of two fundus oculi angiographic imaging system: Optos 200Tx and Heidelberg Spectralis. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Use of fundus autofluorescence images to predict geographic atrophy progression. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Combined grading for choroidal neovascularisation: colour, fluorescein angiography and autofluorescence images. [2018]

9. United States 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. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

[Topographic, 3D and Quantitative analysis of autofluorescence in dry, age-related macular degeneration]. [2009]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Imaging geographic atrophy in age-related macular degeneration. [2022]