OCT Angiography for Retinopathy

(OCTA-RVD Trial)

Recruiting at 1 trial location

Overseen By Ana C Martinez, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Children, Pregnant, Glaucoma, Diabetes, others

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

Compensation: Varies

Number of Visits: 3

1050 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance how doctors use imaging tools to monitor changes in eye conditions related to retinal blood vessels. The study focuses on individuals with diabetes or hypertension, some of whom may also have retinal issues or diabetic retinopathy. Participants will undergo several eye imaging tests, including Optical Coherence Tomography Angiography (OCTA), to help researchers identify early signs of disease progression or improvement. Those with glaucoma or heart disease are not eligible. As an unphased trial, this study allows participants to contribute to advancing medical knowledge and improving future diagnostic techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these imaging techniques are safe for assessing retinal vascular disease?

Research has shown that both spectral-domain and swept-source OCT angiography are safe for people. Spectral-domain OCT angiography offers a non-invasive way to capture detailed images of blood flow in the eye without causing pain. Studies have found it effectively detects changes in diabetic retinopathy, with no significant side effects reported.

Swept-source OCT angiography, another imaging technique, provides even clearer images of the eye’s blood flow. This method is also non-invasive and offers a detailed view of the eye’s tiny blood vessels. Reports have not noted any major adverse events with its use.

Both imaging methods are well-tolerated by patients and provide valuable information without significant risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores advanced imaging techniques like Spectral-Domain OCT Angiography and Swept-Source OCT Angiography to understand retinopathy better. Unlike traditional imaging methods, these cutting-edge technologies provide highly detailed images of the retinal blood vessels, allowing for a more precise assessment of vascular health. Additionally, the trial includes assessments of retinal vascular reactivity, which could offer new insights into how the retina responds to changes in blood flow, potentially leading to earlier detection and improved management of diabetic retinopathy and hypertension-related ocular conditions.

What evidence suggests that these imaging techniques are effective for diagnosing retinopathy?

This trial will compare different imaging techniques for detecting early signs of eye disease related to diabetes. Research has shown that Spectral-Domain OCT Angiography, one of the techniques under study, can effectively identify early signs of diabetic retinopathy (DR) and diabetes mellitus (DM), even before symptoms appear. This imaging technology surpasses older methods because it avoids invasive procedures and provides clearer images. It can detect small changes in the eye's blood vessels that indicate early disease. Meanwhile, Swept-Source OCT Angiography, another technique in this trial, effectively finds areas with reduced blood flow in diabetic retinopathy. It helps identify and measure changes in the eye's blood vessels, indicating the disease's severity. Both imaging techniques offer advanced ways to detect early signs of eye disease related to diabetes. ^{1 3 6 7 8}

Who Is on the Research Team?

Amir Kashani, MD, MPH

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for individuals with retinal vascular diseases like diabetic retinopathy or retinal vein occlusion, as well as those with high blood pressure that may affect the retina. Participants should be able to undergo regular imaging tests to track changes in their eye condition over time.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Imaging and Assessment

Subjects undergo non-invasive, minimal risk, FDA approved diagnostic imaging procedures to identify vascular changes

5 years

Regular visits as per standard-of-care

Follow-up

Participants are monitored for safety and effectiveness after imaging and assessments

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Axial Length Measurement Device
• Fundus Imaging
• Spectral-Domain OCT Angiography
• Swept-Source OCT Angiography

Trial Overview The study is testing different eye imaging techniques: Swept-Source OCT Angiography, Spectral-Domain OCT Angiography, Fundus Imaging, and Axial Length Measurement Device. It aims to observe how these methods can detect changes in the retina due to disease progression or treatment effects.

How Is the Trial Designed?

Group I: Hypertension Only Experimental Treatment 4 Interventions

Subjects in this group only have hypertension with or without ocular pathology related to hypertension. Some subjects in this arm may undergo retinal vascular reactivity assessments.

Group II: Diabetics with and without Diabetic Retinopathy Only Experimental Treatment 4 Interventions

Subjects in this group only have diabetes with or without diabetic retinopathy. Some subjects in this arm will undergo retinal vascular reactivity assessments.

Group III: Diabetics w/ or w/o Diabetic Retinopathy & Hypertension Experimental Treatment 4 Interventions

Subjects in this group have diabetes with or without diabetic retinopathy and hypertension with or without ocular pathology related to hypertension. Some subjects in this arm may undergo retinal vascular reactivity assessments.

Group IV: Controls Experimental Treatment 4 Interventions

Subjects in this group do not have any ocular pathology and are also not hypertensive. Some subjects in this arm will undergo retinal vascular reactivity assessments.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Published Research Related to This Trial

In a study involving 52 eyes from multiple sclerosis (MS) patients and 21 healthy controls, the optic nerve head (ONH) flow index (FI) was significantly lower in MS patients with a history of optic neuritis (ON) compared to healthy controls, indicating potential damage to the optic nerve in these patients.

The study demonstrated that the measurement of ONH FI using swept-source optical coherence tomography (OCT) is highly repeatable and reproducible, making it a reliable tool for assessing optic nerve perfusion and detecting damage related to optic neuritis in MS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical coherence tomography angiography of optic nerve head and parafovea in multiple sclerosis. Wang, X., Jia, Y., Spain, R., et al.[2022]

The study assessed the reproducibility of swept-source optical coherence tomography angiography (SS-OCTA) for measuring vessel density in the macula and optic nerve head (ONH) in 40 healthy subjects, showing good reproducibility in central zones with intraclass correlation coefficients (ICCs) ranging from 0.575 to 0.874.

The results indicated that while the central macular and papillary regions had high reproducibility (ICC = 0.874 and 0.941, respectively), the peripheral zones showed moderate reproducibility, suggesting that SS-OCTA is reliable for central measurements but less so for peripheral assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reproducibility of macular and optic nerve head vessel density measurements by swept-source optical coherence tomography angiography. Fernández-Vigo, JI., Kudsieh, B., Macarro-Merino, A., et al.[2022]

Both spectral domain (SD-) and swept source (SS-) OCTA are effective for imaging retinal layers in patients with central serous retinopathy (CSR), showing no significant differences in their ability to detect structural features.

However, SS-OCTA demonstrated advantages in imaging beyond the retinal layers, particularly in detecting returning signals, and the central serous volume (CSV) significantly influenced imaging capabilities, especially for SD-OCTA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing imaging capabilities of spectral domain and swept source optical coherence tomography angiography in healthy subjects and central serous retinopathy. Wang, F., Zhang, Q., Deegan, AJ., et al.[2022]

A new high-speed, high-sensitivity OCT and OCTA imaging system can capture non-mydriatic 75-degree field of view images in a single scan, improving the efficiency of eye examinations.

This advanced imaging technique achieves capillary-level image quality, which may enhance early detection of eye diseases and improve monitoring of existing conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

75-degree non-mydriatic single-volume optical coherence tomographic angiography. Wei, X., Hormel, TT., Guo, Y., et al.[2021]

Using advanced imaging techniques like spectral domain (SD) and swept source (SS) optical coherence tomography angiography (OCTA), researchers successfully visualized choroidal vessels in all eyes, indicating the effectiveness of these methods for anatomical assessment.

Choroidal blood flow detection was primarily observed in eyes with retinal pigment epithelium (RPE) atrophy, suggesting that intact RPE limits the ability to assess deeper choroidal blood flow, which could impact the evaluation of ocular disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging the Deep Choroidal Vasculature Using Spectral Domain and Swept Source Optical Coherence Tomography Angiography. Diaz, JD., Wang, JC., Oellers, P., et al.[2022]

The new 'Beam expander' (BE) module significantly improved the quality of retinal and choriocapillaris images in optical coherence tomography angiography (OCTA), showing better vessel sharpness and peripheral image quality compared to standard OCTA images in a study of 22 healthy subjects.

Using BE resulted in a higher mean vessel density in the retina, indicating enhanced imaging capabilities that could lead to better assessments of retinal vascularization and potential future applications in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retinal capillary and choriocapillaris assessment using a beam modifier optical coherence tomography angiography module to increase lateral optical resolution. Bonnin, S., Kubach, S., Négrier, P., et al.[2023]

A systematic review of 989 articles on OCTA retinal imaging revealed that 509 required correct image scaling for accurate analysis, but only 41 (8.0%) actually reported using axial length to correct their images.

Most studies (468 out of 989) did not correctly scale their OCTA images, and only 18 (3.8%) acknowledged this as a limitation, raising concerns about the reliability of quantitative measurements in these studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Use of Incorrectly Scaled Optical Coherence Tomography Angiography Images in Peer-Reviewed Studies: A Systematic Review. Llanas, S., Linderman, RE., Chen, FK., et al.[2021]

Both the Zeiss PLEX Elite 9000 and Topcon DRI OCT Triton SS-OCTA devices showed excellent agreement in measuring the area of choroidal neovascularization (CNV) in patients with neovascular age-related macular degeneration, indicating they can be reliably used interchangeably for this purpose.

However, vessel density (VD) measurements were less consistent, with poor agreement observed between different image sizes and between the two devices, suggesting that for accurate longitudinal VD analysis, it is preferable to use the same device consistently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CHOROIDAL NEOVASCULAR AREA AND VESSEL DENSITY COMPARISON BETWEEN TWO SWEPT-SOURCE OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY DEVICES. Ohayon, A., Sacconi, R., Semoun, O., et al.[2021]

In a study involving 72 eyes from 54 patients, both swept-source (SS) and spectral-domain (SD) optical coherence tomography angiography (OCTA) showed comparable effectiveness in detecting macular neovascularization (MNV), with the highest sensitivity achieved when combining en face and cross-sectional OCTA images.

Manual modification of segmentation improved the sensitivity of SS-OCTA significantly to 79.3%, while SD-OCTA remained at 58.6%, indicating that SS-OCTA may have a slight advantage in detecting MNV when adjustments are made.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of swept-source versus spectral-domain optical coherence tomography angiography for detection of macular neovascularization. Lentzsch, A., Schöllhorn, L., Schnorr, C., et al.[2022]

Optical coherence tomography angiography (OCTA) can effectively visualize retinal blood vessels without the use of contrast dyes, providing high-definition images of over 60 degrees of the retina, which is crucial for diagnosing retinal diseases.

In six illustrative cases, OCTA demonstrated superior resolution of retinal microvasculature compared to traditional fluorescein angiography, highlighting its potential for enhanced monitoring and diagnosis of retinal conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wide-field optical coherence tomography based microangiography for retinal imaging. Zhang, Q., Lee, CS., Chao, J., et al.[2022]

A new high-speed swept-source OCT system can capture ultra-wide fields of view up to 90 degrees, significantly improving the resolution and detail of retinal imaging compared to current OCTA devices.

The introduction of a deep learning algorithm for denoising OCTA data enhances the quality of images, making it particularly useful for diagnosing conditions like diabetic retinopathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-Widefield OCT Angiography. Niederleithner, M., de Sisternes, L., Stino, H., et al.[2023]

Optical coherence tomography angiography (OCTA) can noninvasively image and measure changes in retinal structures associated with neuronal diseases, such as Alzheimer's, Parkinson's, and multiple sclerosis.

The study found that these diseases are linked to a reduction in retinal vessel density and atrophy of retinal layers, suggesting that OCTA parameters could serve as valuable biomarkers for assessing neurovascular health in these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Optical coherence tomography angiography in neuronal diseases : Preliminary findings]. Mardin, CY., Hosari, S.[2020]

In a study involving 14 eyes from 13 patients, ultrahigh-speed swept-source (SS) optical coherence tomography angiography (OCTA) detected significantly larger areas of choroidal neovascularization (CNV) compared to spectral-domain (SD) OCTA, indicating its superior ability to visualize CNV associated with age-related macular degeneration.

The total CNV area measured with SS OCTA was 0.949 mm² compared to 0.340 mm² with SD OCTA for a 3 mm x 3 mm field, and 1.218 mm² versus 0.604 mm² for a 6 mm x 6 mm field, both showing statistically significant differences (P < .001), suggesting that SS OCTA may provide a more comprehensive view of CNV vasculature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Choroidal Neovascularization Analyzed on Ultrahigh-Speed Swept-Source Optical Coherence Tomography Angiography Compared to Spectral-Domain Optical Coherence Tomography Angiography. Novais, EA., Adhi, M., Moult, EM., et al.[2022]

Citations

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Recent advances and applications of optical coherence ... OCTA effectively identifies DR lesions and detects early vascular abnormalities in DM and prediabetes, surpassing FFA in noninvasiveness and resolution.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03022292

The IAI-OCTA Study; a Study of OCT-Angiography Analysis ... A study investigating the ability of OCTA imaging technology to identify and analyze untreated type 1, 2, and 3 neovascular membrane lesions in treatment ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0039625724000213/pdf

Optical coherence tomography angiography in diabetic ... OCTA reveals early microvascular alterations in prediabetic and NDR eyes, which may coexist with sub-clinical neuroretinal dysfunction. Its applications in NPDR ...

4. mdpi.com mdpi.com/2227-9059/13/5/1251

HD-OCT Angiography and SD-OCT in Patients with Mild or ... HD-OCTA and SD-OCT can detect vascular changes and structural signs of retinal neurodegeneration before clinically apparent diabetic retinopathy.

5. ophthalmologyscience.org ophthalmologyscience.org/article/S2666-9145(22)00070-7/fulltext

Longer Interscan Times in OCT Angiography Detect Slower ... Longer interscan times in OCT angiography detect slower capillary flow in diabetic retinopathy. Yoshihiro Kaizu, MD, PhD.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11268430/

Optical coherence tomography angiography in diabetic ... Optical coherence tomography angiography metrics with potential for use in clinical trials of diabetic retinopathy, diabetic macular edema, and diabetic macular ...

7. ophthalmologyscience.org ophthalmologyscience.org/article/S2666-9145(21)00028-2/fulltext

Quantitative Parameters from OCT Angiography in Patients ... Quantifying microvascular density and morphology in diabetic retinopathy using spectral-domain optical coherence tomography angiography.

8. journalretinavitreous.biomedcentral.com journalretinavitreous.biomedcentral.com/articles/10.1186/s40942-015-0005-8

A review of optical coherence tomography angiography ... OCTA is a new, non-invasive imaging technique that generates volumetric angiography images in a matter of seconds.