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A retina specialist discusses impressions and key take away points from patient case.

Impressions and take away points from Patient Case #2

Eduardo Uchiyama MD reviews the case of a 55-year-old male with non-infectious uveitis.

Patient case #2: 55-year-old patient with recurrent uveitis

A uveitis specialist discusses impressions and key take away points from patient case.

Impressions and take away points from Patient Case #1

Dr. Eduardo Uchiyama, MD reviews the case of a 65-year-old female with uveitis. 

Patient case #1: 65-year-old patient with uveitis

Join John Kitchens, MD, and David Brown, MD, as they explore the PULSAR study results and their impact on managing neovascular age-related macular degeneration in your practice. They touch upon dosing strategies and also highlight two new drugs, faricimab and aflibercept 8 mg. They also discuss the potential benefits of increased molar dosing and the importance of maintaining dryness and durability in patient care.

See the key takeaways below, and listen to the full podcast for all the clinical pearls.

Drug dosing and half-life in retina treatment.

Highlighting developments in ocular drug delivery, including new formulations of existing drugs and potential challenges in the clinic.

Discussing increased molar dosing of aflibercept.

Explaining the variability in patient clearance rates and their impact on treatment outcomes.

Aflibercept 8 mg, including study findings and clinical practice applications.

Clinical practice for aflibercept dosing, including loading doses and extension intervals.

Prioritizing individualized approach based on patient's response and disease activity.

The safety and efficacy of a drug for treating retinal diseases.

Extending drug treatment from 8 weeks and onward with positive patient response.

Safety data and potential label change with regulatory agencies.

The importance of manufacturing processes and the challenges of creating fully human antibodies to VEGF.

Join John Kitchens, MD, and David Brown, MD, as they explore the PULSAR study results and their impact on managing neovascular age-related macular degeneration in your practice.

PULSAR Study Findings: Implications for Treating nAMD in Clinical Practice

OCT) technology has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA).

OCT is specifically engineered for cerebrovascular navigation. This allows for detailed visualization of the brain's vascular anatomy which can provide improved diagnostic capabilities and enhance treatment precision.

OCT allows visualization past the arterial lumen, through the arterial wall and even into the perivascular space. It allows for high-resolution imaging using backscattered light to produce cross-sectional images of biological tissue with micro-meter resolution.

OCT designation, Spryte Medical also announced it has been included in the FDA’s Total Product Life Cycle Advisory Program (TAP). TAP is a program that aims to “help speed development of high-quality, safe, effective, and innovative medical devices that are critical to public health.” According to the company, being included in TAP will help provide valuable support and feedback from the FDA, which will “further accelerate the path to market for 

Demetrius Lopes, MD, commented on the designation in a press release from Spryte.

“Neurointervention has had an incredibly positive impact on the treatment of cerebrovascular conditions. 

OCT intravascular imaging will allow us to advance the field even further. With this technology we will be able to better visualize disease and devices, guide our decision making and deliver even better patient care. I have followed the development of intravascular imaging in cardiology for many years,” said Lopes.

Spryte Medical Receives Breakthrough Device Designation from FDA for Revolutionary 

OCT) Technology. Press release. Released July 22, 2024. Accessed July 22, 2024. 

https://www.businesswire.com/news/home/20240722486759/en/Spryte-Medical-Receives-Breakthrough-Device-Designation-from-FDA-for-Revolutionary-neuro-Optical-Coherence-Tomography-nOCT-Technology

The nOCT allows for detailed visualization of the brain's vascular anatomy.

clinical

Neuro OCT by Spryte Medical receives Breakthrough Device Designation from FDA

In the pursuit of optimizing care for diabetic macular edema (DME), the PALADIN study (NCT02424019), a nonrandomized, open-label,
observational phase 4 trial spanning 36 months, sheds light on the real-world impact of the 0.19 mg fluocinolone acetonide (FAc; Iluvien) implant. It evaluated the 0.19-mg FAc implant in 202 eyes of 159 patients diagnosed with DME,

 providing a nuanced understanding of how the Iluvien (Alimera Sciences) implant can potentially improve vision and reduce treatment burden.

The PALADIN study observed improvement in best-corrected visual acuity (BCVA) following the administration of the 0.19 mg FAc implant. Over the 36 months post FAc, there was a statistically significant mean improvement of 4.5 letters compared to baseline (

= .0253). This contrasts with the 6.4-letter decline in visual acuity recorded during the preceding 36 months,

 suggesting that the FAc implant may play a beneficial role in enhancing vision, likely by addressing the known undertreatment with anti-VEGF injections seen in real-world practice. Randomized clinical trials have shown a positive correlation between the number of anti-VEGF injections and visual gains. However, in real-world observational studies, patients received fewer injections, correlating with notably smaller visual improvements.

 Indeed, during the 36 months before the implant in this study, 75% of eyes received 5 or fewer yearly treatments.

The study highlights the treatment burden associated with DME by examining the frequency of interventions. In the 36 months leading up to FAc treatment, the eyes received a mean of 3.5 yearly treatments. With the introduction of the FAc implant, there was a notable reduction in the mean number of yearly supplemental treatments to 1.7 (

< .001). Additionally, 68% of eyes required 2 or fewer supplementary interventions annually post FAc, and at the end of the 36-month study, 25% of the eyes remained completely free of any additional treatment.

 This decline in treatment frequency indicates a potential reduction in the overall treatment burden for DME patients over a 3-year period.

Eyes that received supplemental treatments post FAc exhibited a higher incidence of intraocular pressure (IOP)–related events, underscoring the importance of continual monitoring and management of IOP. It is reassuring that the IOP events in PALADIN were similar to other postapproval studies and numerically lower than in the phase 3 FAME study (NCT01304706), likely due to the prior steroid challenge that is required by the label.

The findings from the PALADIN study have guided the design of the NEW DAY study (NCT04469595). In this phase 4, prospective clinical trial, treatment-naive eyes with DME are randomly assigned either to aflibercept or Iluvien plus aflibercept as needed. The 18-month NEW DAY results are anticipated in early 2025.

The measured improvement in vision and the reduction in treatment burden are noteworthy findings. While the findings are promising, maintaining a balanced view and addressing associated considerations such as IOP-related events are paramount. Integrating these insights into clinical practice may pave the way for a more nuanced and patient-centric treatment approach, where Iluvien can play a strategic role in improving outcomes and reducing the overall burden of care. 

1. Singer MA, Sheth V, Mansour SE, Coughlin B, Gonzalez VH. Three-year safety and efficacy of the 0.19-mg fluocinolone acetonide intravitreal implant for diabetic macular edema: the PALADIN study. 

. 2022;129(6):605-613. doi:10.1016/j.ophtha.2022.01.015

2. Merrill PT, Holekamp N, Roth D, Kasper J, Grigorian R; PALADIN Study Group. The 0.19-mg fluocinolone acetonide intravitreal implant reduces treatment burden in diabetic macular edema.

2023;248:16-23. doi:10.1016/j.ajo.2022.09.017

3. Bailey C, et al. Poster presented at: 8th World Congress on Controversies in Ophthalmology (COPHy); March 30-April 1, 2017; Madrid, Spain.

4. Merrill PT, Cutino A, et al. 0.19 mg fluocinolone acetonide implant improves vision and treatment burden in patients with diabetic macular edema: the PALADIN study. Presented at: American Academy of Ophthalmology Annual Meeting; November 5, 2023; San Francisco, CA.

Enhancing patient outcomes

Ultrawidefield (UWF) imaging is defined as retinal imaging beyond the vortex vein ampullae in all quadrants with a single capture, equating to a 110° to 220° view of the retina.

 Compared to the limited 30° to 50° view of traditional fundus photography, UWF imaging provides unparalleled access to the peripheral retina, enabling the visualization of previously undetected pathologies and deepening our understanding of retinal disorders.

For example, the Optos UWF imaging device (Optos plc) Dunfermline, UK, is capable of capturing 200°, or 82% of the retina in a single image, which it achieves in less than 0.5 seconds without the need for mydriasis.

Until recently, Optos UWF color imaging has relied on confocal scanning laser ophthalmoscopy with red (633 nm) and green (532 nm) lasers

; monochromatic red and green laser images are obtained, which are merged to form a pseudocolor retinal image.

 The addition of a blue laser (488 nm) to the Optos California device, one can obtain single-capture 200° red/green/blue (RGB) composite color retinal images that can mimic the natural color of the retina as seen on fundus examination.

This new modality is a welcome feature, since it combines the extensive field of view of UWF with a natural retinal color representation. Color RGB images can be acquired simultaneously with color RG images, providing 2 UWF color images in 1 capture. The new modality also allows for blue laser autofluorescence in addition to green laser autofluorescence. Thus, more retinal detail can be obtained without increasing the test duration.

Color RGB technology uses simultaneous red, green, and blue laser scans to acquire natural color images of the retina.

 Each of the laser sources in the RGB imaging system can also be applied individually to image different layers of the retina.

 While the green laser best visualizes the sensory retina and retinal pigment epithelium (RPE) and the red laser can image the choroid,8 the short-wavelength blue laser best captures the superficial retinal layers.

 Thus, in addition to color fundus photography, RGB imaging has potential application in the detection of retinal nerve fiber layer (RNFL) defects, which is a marker of early glaucomatous damage.

Indeed, confocal scanning laser ophthalmoscopy with blue laser has been found useful in detecting RNFL defects in cases of suspected glaucoma.

UWF RGB is also likely to be a useful diagnostic tool in other conditions where clinical fundus examination is precluded due to poor ocular fixation. UWF RG imaging has been able to successfully capture panoramic retinal images in patients with nystagmus,

 but RGB imaging can further expand the information we obtain from the acquired images.

An initial study investigating the clinical benefits of RGB color imaging reported clear visualization of vitreoretinal and superficial retinal structures, such as vitreous opacities and optic nerve fibers, due to the inclusion of blue laser.

 Pathologies such as epiretinal membrane and proliferative vitreoretinopathy were clearly visualized on RGB imaging. The high contrast of RGB images enhanced the visibility of peripheral retinal holes, tears, schitic changes, and lattice degenerations. The natural color demonstrated various retinal lesions, such as drusen, retinal exudates, superficial retinal hemorrhages, neovascularization, ghost vessels, and retinochoroidal atrophy. On the other hand, deep retinal or choroidal structures were better imaged with the RG modality, which improved visualization of subretinal fibrosis, retinal and choroidal vasculature, and deep retinal hemorrhages. RG images characterized RPE changes and enhanced the contrast between areas of geographic atrophy and normal retina in age-related macular degeneration (AMD). Thus, the findings of this study suggest that UWF RG and RGB imaging are complementary techniques that provide valuable information for more precise clinical decision-making.

At the Lariboisière Hospital, Paris, we were fortunate to get early access to the new UWF RGB imaging system.It was immediately evident that the
acquired images had enhanced clarity and more natural colors true to what is seen on clinical fundus examination, but our primary concern was to investigate whether these refinements improved our ability to diagnose and treat patients.

We found that minute retinal details were clearly visible, which is clinically significant in cases of diabetic retinopathy (DR) where undetected small hemorrhages and microaneurysms can lead to underestimation of true DR severity.

 We observed that color RGB replicated the actual appearance of the retina, making subtle hemorrhages and intraretinal microvascular abnormalities (IRMA) easy to spot 

). Crisp images were obtained even in cases with suboptimal viewing conditions due to media opacities. Thus, we could detect early lesions in addition to more peripheral lesions, enabling accurate staging and treatment of DR. In the initial results from our ongoing study comparing UWF RG and RGB imaging in DR, we were able to detect more hemorrhages and IRMA, as well as more cases of moderate and severe DR, with RGB images.

The high contrast and visibility of color RGB images were also expected to assist in the detection of peripheral retinal holes and tears. In the case shown in 

, a retinal detachment was noted on UWF RGB imaging with the eye in primary position. Although the UWF image showed the location of the detachment with a single, 200° retinal capture, it was not immediately apparent if there were any associated retinal tears. However, on changing the fixation point (gaze-steering), we were able to observe the far periphery, revealing tears in the superior and superonasal peripheral retina, which were clearly visible due to the natural color representation of RGB image (

. A feature of the UWF software is its built-in auto-montage capability: The device automatically combines the gaze-steered images into a single image that captures 97% of the retina,⁴ showing the full extent of the detachment with all associated tears (

 shows another display of the auto-montage feature in a patient post-retinal detachment surgery, where the panoramic color image makes it appear as if the entire eye has been laid open for the examiner.

In case of ocular tumors, an accurate representation of tumor appearance is essential for a precise diagnosis of the underlying pathology.

 With the RGB modality, we found that the color features of ocular tumors were faithfully imaged, enabling accurate evaluation of lesions. Color RGB was especially helpful in examining melanocytic lesions to distinguish choroidal nevi from choroidal melanomas and follow-up.

Other ophthalmologists have had similarly positive experiences with the new UWF RGB images, noting the great clarity and detail for a variety of retinal disorders.

Early clinical experiences suggest that the addition of color RGB modality to UWF imaging is a new tool in our diagnostic toolbox that will be useful in accurately and efficiently diagnosing retinal pathologies, even in conditions unconducive to reliable retinography such as coexisting media opacities. This new modality is a significant addition in the field of UWF imaging that empowers physicians to provide more bespoke patient care. With its natural colors and expansive views of the retina, UWF RGB is likely to play an integral role in the diagnosis and management of retinopathy in routine ophthalmic practice. 

Erginay is senior consultant ophthalmologist at Lariboisière Hospital, Paris, France, and specializes in vitreoretinal disorders. The author sits on the Optos medical advisory board and has no financial interests to disclose.

1. Choudhry N, Duker JS, Freund KB, et al. Classification and Guidelines for Widefield Imaging. 

. 2019;3(10):843-849. doi:10.1016/j.oret.2019.05.007

2. Kumar V, Surve A, Kumawat D, et al. Ultra-wide field retinal imaging: A wider clinical perspective. 

. 2021;69(4):824. doi:10.4103/ijo.IJO_1403_20

3. Hirano T, Imai A, Kasamatsu H, Kakihara S, Toriyama Y, Murata T. Assessment of diabetic retinopathy using two ultra-wide-field fundus imaging systems, the Clarus® and OptosTM systems. 

. 2018;18(1):332. doi:10.1186/s12886-018-1011-z

4. Optos Products. Accessed March 6, 2024. https://www.optos.com/products/

5. Stanga PE, Bravo FJV, Reinstein UI, Stanga SFE. New 200° Single-Capture Color Red-Green-Blue Ultra-Widefield Retinal Imaging Technology: First Clinical Experience. 

. 2023;54(12):714-718. doi:10.3928/23258160-20231019-03

6. Optos announces new Ultra-widefield color image modality, providing additional retinal visualization to eyecare professionals. Published May 30, 2023. Accessed March 6, 2024. https://www.optos.com/press-releases/2023-optos-announces-new-uwf-color-image-modality/

7. Terasaki H, Sonoda S, Tomita M, Sakamoto T. Recent Advances and Clinical Application of Color Scanning Laser Ophthalmoscope. 

. 2021;10(4):718. doi:10.3390/jcm10040718

8. Gordon‐Shaag A, Barnard S, Millodot M, et al. Prevalence of choroidal naevi using scanning laser ophthalmoscope. 

. 2014;34(1):94-101. doi:10.1111/opo.12092

9. Medeiros FA, Vizzeri G, Zangwill LM, Alencar LM, Sample PA, Weinreb RN. Comparison of Retinal Nerve Fiber Layer and Optic Disc Imaging for Diagnosing Glaucoma in Patients Suspected of Having the Disease. 

. 2008;115(8):1340-1346. doi:10.1016/j.ophtha.2007.11.008

10. Joung JY, Lee WJ, Lee BR. Comparison of Blue and Green Confocal Scanning Laser Ophthalmoscope Imaging to Detect Retinal Nerve Fiber Layer Defects. 

. 2019;33(2):131. doi:10.3341/kjo.2018.0075

11. Kothari N, Pineles S, Sarraf D, et al. Clinic-based ultra-wide field retinal imaging in a pediatric population. 

. 2019;5(S1):21. doi:10.1186/s40942-019-0171-1

12. Kumar V, Tewari R, Chandra P, kumar A. Ultra wide field imaging of coats like response in Leber’s congenital amaurosis. 

. 2017;31(2):122-123. doi:10.1016/j.sjopt.2017.02.007

13. Callaway NF, Mruthyunjaya P. Widefield imaging of retinal and choroidal tumors. 

. 2019;5(S1):49. doi:10.1186/s40942-019-0196-5

The introduction of red/green/blue (RGB) color is a welcome addition to ultrawidefield imaging that will aid in the screening and detection of retinal diseases.

True-to-life retinal imaging with the new ultrawidefield color RGB modality

Carl Danzig, MD, 24 week PRISM trial results at CTS 2024

Carl Danzig, MD, spoke with us about his presentation on the 24 week results of the PRISM trials for wet AMD. He gave this presentation at Clinical Trials at the Summit meeting in Park City, Utah on June 8, 2024.

Editor's note: The below transcript has been lightly edited for clarity.

I'm David Hutton of Ophthalmology Times. Clinical Trials at the Summit is being held this year in Park City, Utah. Dr. Carl Danzig joins us today to discuss his presentation at this year's meeting. Thanks for joining us today. Can you tell us about the key points in your presentation, and their implications for ophthalmology?

Absolutely. David, thank you so much for having me. I'm really excited to present this important data this weekend at the clinical trials summit meeting in Park City. I'll be discussing the 24 week results from the PRISM trials, a randomized Phase 2, dose expansion stage, evaluating 4D-150 in high need, wet AMD patients. And I'm presenting a subgroup analysis of injection free patients.

The important thing to note about this trial is that it included the highest need patients that we have. Those patients had 6 injections or more over 12 months, they had to have fluid at screening with a baseline thickness of 325 or more. And the average thickness to enter the trial was over 400. So with this patient group, we know that when we want to look at molecules that control disease, we want to do it in the hardest to treat patients. And that's what we looked at here. So 4D-150 is a primate evolved intravitreal R1 capsid, that carries a dual transgene payload of aflibercept and VEGF-C RNAi. So as a single intravitreal administration, with a robust pan-retinal, trans-gene expression of four distinct VEGF family members. And what we saw in the trial was again, single injection, 50 microliters, it was safe. Okay, patients used only topical Darzalex prophylaxis. And 38 out of 39 patients did it without needing any bump up, only one patient during the taper had to be bumped up on their steroids due to mild anterior inflammation. Okay, and that resolved. No patient had to be restarted on any steroid regimen, after they tapered it off, up to 48 weeks.

Furthermore, what we saw in this high need patient population was a reduced injection burden with an 89% reduction. And 63% of the patients were injection free. We saw excellent anatomic control. We saw sustained reduction in retinal thickness and stabilization of CST. That's in comparison to that normal seesaw pattern we see in the aflibercept arm that's treated every 8 weeks. And furthermore, in these high need patients, in the ones that were supplement free, so they had their injection of 4D-150 at baseline, and they went 24 weeks without needing any injection. They had excellent anatomic control in the 3E10 arm. And every time point was below the aflibercept even at the trough of the seesaw. So this is really encouraging.

Furthermore, we've seen from the Phase 1 patients that there's some of them that went up to 2 years, so we see durability. And this is very exciting for our patients, because we're always looking for what can we do more for our high need patients and and this is what we have and we're looking forward to finishing the Phase 2 trial and hopefully starting a Phase 3 trial in quarter one of next year.

CTS 2024: 24 week results from the PRISM trials

Understanding Dry AMD: Early, Intermediate, and Geographic Atrophy Stages with Key Assessment Endpoints

to discuss the role of structural and functional biomarkers in dry AMD treatment as well as the future of clinical trials. She presented at the Clinical Trials at the Summit conference on June 8, 2024, in Park City, Utah. Lad shares some key takeaways here with Group Editorial Director Sheryl Stevenson.

- The following transcript has been lightly edited for clarity.

We are joined today by Dr. Eleonora Lad, who is among the presenters at this year's Clinical Trials at the Summit. So delighted to see you! Looking forward to your talk. You will be presenting on dry AMD regarding structural and functional biomarkers. What can you tell us about your talk?

Thanks so much. It's an honor to be here and be interviewed today. I guess I'll start with some take-home points and then I'll go through the salient details that I want to take away from this.

So briefly, this talk is about the stages of dry AMD from early to intermediate to geographic atrophy [GA], which is the late stage of AMD and the only one for which there are currently available FDA treatments — 2 in number since last year. We are assessing which endpoints are most useful for these different stages. For early and intermediate AMD, there's certainly value in dark adaptation testing, microperimetry, and structure-function correlation analyses. GA is different and that's why so many trials have failed so far, because best-corrected visual acuity is not the best endpoint, which is why we use structural endpoints like fundus autofluorescence. But there are elements to BCVA that are useful for geographic atrophy. So we now understand from natural history trials and Proxima and lampalizumab studies that higher best-corrected visual acuity loss is in the better eye, not the worst eye that is typically enrolled in the therapeutic studies. Eyes with better starting acuity also have higher BCVA loss, so more opportunity to change, also smaller lesions that are unifocal, and also the presence of reticular pseudodrusen or subretinal drusenoid deposits is also a marker of higher BCVA loss. So had we enrolled those patients in the therapeutic studies of complement inhibitors in the past year we would have seen perhaps a BCVA loss in the prespecified analyses. That's what we gleaned from natural history data so far.

Reading speed has a more acute slope or decline than BCVA so holds more promise. Low luminance visual acuity is also promising and there are complex relationships between GA lesions and BCVA and also microperimetry. The analysis of the perilesional points at the edge of GA is a good marker of disease activity and is likely to show a change with newer protocols. Now, there are some post-hoc analysis of the GA phase 3 anti-complement trials, and prespecified analysis of the recent phase 2 trial of the C1q inhibitor that have revealed functional benefits in best-corrected visual acuity, low luminance visual acuity, and microperimetry in the perilesional area. So those are finally panning out.

And just to highlight the future trials of dry AMD can use all these prior data and knowledge to define subgroups of GA-affected eyes that have high risk of both anatomic expansion for the primary endpoint if you want it to be GA area or concomitant functional loss. So we'll be able to construct better studies in the future with our current knowledge to design better studies for both structural and functional assessments.

Thank you for that summation. So what might be the next steps in this research?

The next step is to probably get a paper out, a detailed analysis on all these biomarkers, structural and functional, in geographic atrophy in earlier stage of disease...move treatments in earlier stages. Right now, many industry sponsors are addressing extrafoveal lesions that are farther out than prior studies. They're limiting lesion size so we can pick up the functional deficit better. In the end, what we'll need to do is address the intermediate stage of disease. We'll need to have better trial designed for intermediate AMD. I think there's definitely value in the ellipsoid zone area as a structural biomarker that could be primary with a functional surrogate that could be dark adaptation with the modified protocol.

And we can use other functional tests as well with newer technology like virtual reality [VR] goggles. We will use a lot of information from our glaucoma colleagues where they do multiple repeated testing over time using VR goggles. We can get more tests done at home, etc, or in a clinic setting so that we can lower that margin of error of each test to show efficacy to regulatory agencies like FDA and EMA [European Medicines Agency]. A lot of good work to be done but we want to design better studies and move the treatment to earlier stages is the bottom line.

 That's fascinating. And speaking more about research, what advice would you give to researchers and clinicians about dry AMD?

 To start imaging the patients robustly using high-resolution OCT with ideally 97 line scan. So it can get as much information for future AI analyses and efforts on ellipsoid zone, attenuation, partial, total, or total easy loss depending on terminology....all the biomarkers of interest, and also....the drusen characteristics are very important. And also autofluorescence because they want to understand more about the patterns of GA as they expand over time.

And then work with colleagues that like to do functional testing. I know that's not easy to implement in a busy clinical practice, but maybe partner with researchers or optometrists and do some dark adaptation at some point and learn more how to do it correctly and microperimetry because I think it'll become useful for us.

Any additional thoughts or key takeaways you'd like to share about the future of dry AMD and clinical trials?

 I think the future of dry AMD is extremely bright. We have an explosive pipeline currently with multiple mechanism of actions. I think many of them are very promising. They range from drugs, devices, to drug-device combinations so the future I think is really bright. I tell my patients in clinic this every day, and it gives them a lot of hope.

In addition to the first 2 FDA approvals that started the field of therapeutics in advanced dry AMD, I think there'll be a lot more room for prevention of vision loss and even improving vision if these drugs work well or devices. So a bright future ahead for the treatment of dry AMD and a lot of meaningful work that needs to be done in the space.

Thank you so much. It certainly is a fascinating time to be an ophthalmology and we really appreciate your time today.

Thank you so much for your interest. The pleasure is mine.

Eleonora Lad, MD, PhD, discusses the stages of dry AMD from early to intermediate to geographic atrophy, while also assessing which endpoints are most useful for these different stages.

Eduardo Uchiyama, MD

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