The Impact and Swagger Study

Changes in Progress to Late AMD (nGA, GA or MNV) Clinical Trial

— BIRC-01  

Official title:

Non Exudative Age-Related Macular Degeneration Imaged With Swept Source Optical Coherence Tomography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03972800
• Other study ID #: BIRC-01 IMPACT
• Status: Recruiting
• Start date: June 2016
• Est. completion date: June 2020

Study information

• Verified date: May 2019
• Source: Tufts Medical Center
• Contact: Jen Tourtellot
• Phone: 855-535-2472
• Email: admin[@]bostonimagereadingcenter.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

We wish to better understand the role of the choriocapillaris (CC) in the formation and progression of non-exudative in age related macular degeneration (armd) by imaging the retinal pigment epithelium (rpe) and the choroidal microvasculature and by studying their inter-dependence to determine if the loss of the CC could prove useful as an anatomic clinical trial endpoint in future drug trials.

Description:

This is a longitudinal observational study that will look at 300 subjects, 200 with intermediate AMD in at least one eye, or with AMD in one eye, either early or intermediate, and with late AMD (exudative) in the other eye, and 100 subjects with nGA or GA in at least one eye. At baseline, subjects will receive visual acuity testing, low luminance acuity testing, a complete ophthalmological exam, color fundus photos, fundus autofluorescence imaging, infrared reflectance imaging, and OCT imaging with SS-OCTA. SS-OCTA imaging is a non-invasive technique that can be used to evaluate the retinal and choroidal vasculature without the need for intravenous dyes. OCTA uses scanning patterns and algorithms that detect the flow of erythrocytes in the retina and choroid by evaluating the changes in the OCT reflected signal that occur from the movement of erythrocytes. Subjects will be followed with OCTA at 3-month intervals for a total of 2 years. Interim analysis will also be conducted when all subjects have completed a 1-year follow up. All subjects will be imaged with the Zeiss SS-OCT/OCTA system. This SS-OCTA system is being used because it provides better visualization of the choroid compared with spectral domain OCT imaging. Moreover, the faster scanning speed and the acquisition of multiple volumetric data sets allows for variable interscan time flow analysis, which enables the detection of variable flow rates in subjects with late AMD as shown previously by our group (Choi et al Ophthalmology 2015). Moreover, the ability to cross-register OCTA with OCT B scans allows for correlation between structure and flow information. All other imaging will be performed at baseline and at months 12 and 24 The target population is all subjects who are at least 50 years of age and have a clinical diagnosis of non-exudative AMD in at least one eye. There will be 2 subject cohorts. Cohort 1 consists of subjects with iAMD in both eyes, and at least one eye with a drusen volume in the central 3 mm circle centered on the fovea of at least 0.02 mm3 in the absence of GA or nGA as diagnosed with OCT en face imaging. Nascent GA will be defined as a bright area of hyper transmission with a greatest linear dimension of 125 microns as seen on en face OCT imaging using the sub-RPE slab image and confirmed on structural B-scan images OR subjects with AMD (early or intermediate) diagnosed in one eye and exudative AMD diagnosed in the fellow eye. There can be no evidence of nGA or GA in the eye with early/intermediate AMD. The eye with early/intermediate AMD can be enrolled in the study regardless of drusen volume. Cohort 2 consists of subjects with a diagnosis of late AMD and have presence of GA or NGA secondary to AMD that is at least the size of a large druse (125 microns in diameter; 0.05 mm2) and no greater than 7 disc areas (17 mm2) in at least one eye. During the study, the non-study fellow eye will be imaged and data collected irrespective of the level and type of AMD in the fellow eye The sample size for each cohort is based on the observed rates of conversion from iAMD eyes with pure drusen to geographic atrophy and MNV of around 10% in 2 years and the expected growth rate of GA as observed in the preliminary natural history study and the COMPLETE study. (Garcia, Rosenfeld et al 2014; Schaal, Rosenfeld, et al 2016). Based on these rates, a sample size over 100 per AMD type (iAMD, dry/wet, nGA/GA) does not result in any significant narrowing of the projected 95% confidence intervals.

Cohort 1 will have the option to be monitored using the DigiSight Checkup Vision Assessment System to evaluate whether this provides an early indication of onset or progression of MNV in subjects with asymptomatic early MNV All subjects will also receive optional genetic testing to correlate to their exam findings and disease progression. Subjects who convert to exudative AMD during the study will be treated as per the enrolling physician's standard of care and will continue to be scanned per protocol, allowing for a wider interval of +/- 30 days around the standard timing of scanning to avoid excessively frequent visits.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2020
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Aged 50 and over

2. Clinic diagnosis of non-exudative iAMD in at least one eye with a drusen volume in the central 3 mm circle centered on the fovea of at least 0.02 mm3 in the absence of GA or nGA as diagnosed with OCT en face imaging OR Clinical diagnosis of early or early/intermediate stage AMD in one eye in the absence of nGA or GA and exudative AMD in the other eye OR clinical diagnosis of GA or nGA secondary to AMD that is at least the size of a large druse (125 microns in diameter; 0.05 mm2) and no greater than 7 disc areas (17 mm2) in at least one eye which has never been treated with anti-VEGF agents

3. Willing and able to comply with clinic visits and study-related procedures

4. Provide signed informed consent

Exclusion Criteria:

A subject who meets any of the following criteria will be excluded from the study:

1. Below the age of 50

2. Subjects with exudative AMD in both eyes

3. Eyes with evidence of non-proliferative and proliferative diabetic retinopathy.

4. Presence of confounding ocular diagnosis such as myopia >6D, or other ocular conditions that may cause retinal pigment epithelium atrophy or exudative MNV

5. Subjects currently or within the last 6 months enrolled in other interventional clinical trials.

6. Subjects unable to give informed consent.

7. Subjects who are unable to comply with imaging guidelines

Related Conditions & MeSH terms

• Changes in Progress to Late AMD (nGA, GA or MNV)
• Changes in Subjects With Pre-existing nGA/GA That Have Disease Progression
• Disease Progression

Intervention

Device:
• Swept Source Optical Coherence Tomography
All subjects will obtain fundus photos, fundus autofluorescence and structural OCT scanning using the commercial devices available in the clinics of the enrolling sites. All subjects will also be imaged on the Zeiss Plex Elite prototype swept source OCTA. The PLEX Elite prototype is considered a Class II medical device with a Class 1 swept source laser. The PLEX Elite is a CE marked instrument that is currently marketed outside of the US, and is similar in function to the Cirrus HD-OCT that has been cleared by the FDA (K063378; K083291; K111157, K150977). The PLEX Elite has received clearance from the United States Food and Drug Administration (FDA) for use as an investigational device only (K161194).

Locations

Country	Name	City	State
United States	Boston Image Reading Center	Boston	Massachusetts
United States	Bascom Palmer Eye Institue	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1) Presence of choroidal perfusion deficits	1) Presence of choroidal perfusion deficits and their temporal and geographic relationship to morphologic changes in the RPE/Bruch's/retina complex, such as presence of drusen, nGA and GA/ the formation of nGA and GA /Subretinal drusenoid deposits evaluated at 1 year and 2 years of follow up.	1 year