In this episode of Evidence Based Retina, Rishi P. Singh, MD, FASRS is joined by David Chin Yee, MD to discuss the Samsara Vision SING IMT and its two ongoing clinical trials for treatment of advanced, end-stage age-related macular degeneration (AMD).
Dr. Chin Yee is a vitreoretinal surgeon and physician partner at Georgia Retina, where he also serves as the Director of Clinical Trials.
SING IMT fast facts
- New technology: The small incision, new generation (SING) implantable miniature telescope (IMT) is a micro-sized, 3.6mm diameter telescope implant requiring only a 6.5mm incision—roughly half the size required by previous IMT technology.1,2
- Clinical trials: Two multi-center clinical studies are currently ongoing.3,4
- The CONCERTO study is recruiting at locations around the United States to determine the safety and efficacy of SING IMT for treatment of late-stage AMD and develop a pathway toward FDA approval.3
- The PERSPECTIVE study aims to assess safety and efficacy in pseudophakic patients with late-stage AMD located in Europe where SING IMT is already approved as a CE-marked medical device.4
- Primary endpoint: Clinicians will measure improvement in visual acuity and reading ability from pre-surgery baseline to post-operative readings.3,4
- Safety: SING IMT is available in CE-referenced countries, but it is not yet FDA-approved.3,4
- Importance: Advanced AMD is a leading cause of vision impairment with limited treatment options. SING IMT presents a viable micro-optic surgical modality to improve patient vision and quality of life.1,5
A deeper dive into SING IMT
Advanced AMD affects an estimated 8 million individuals worldwide, and that number is projected to grow to more than 20 million by 2050.6 With limited treatment options for advanced AMD, clinicians are looking at novel technologies that can offer solutions.
A new generation of IMT
The first implantable miniature telescope device for AMD treatment acquired FDA approval in 2010.7 More than a decade later, and a newer, revamped second generation of the IMT technology offers greater improvements. Most notably, the SING IMT requires only a 6.5mm incision—roughly half the size required by the earlier IMT platform.1,2
Dr. Chin Yee says there are currently two ongoing clinical trials to assess the safety and efficacy of Samsara Vision’s SING IMT device. The CONCERTO study is recruiting an estimated 125 participants at locations around the United States to determine the safety and efficacy of SING IMT for treatment of late-stage AMD and develop a pathway toward FDA-approval.3
One question raised by Dr. Singh addresses the commentary surrounding whether a patient must be phakic or pseudophakic to be a candidate for IMT. The PERSPECTIVE study is designed to address this question, enrolling a cohort of 44 participants (around half the size of the CONCERTO study), focused on pseudophakic patients with late-stage AMD located in Europe where SING IMT is already approved as a CE-marked medical device.4
Dr. Chin Yee says they will use two techniques with the pseudophakic patients, either by an IOL exchange or using a “piggyback model” with the same implant.
Early data from a previous retrospective study of 6 month outcomes support SING IMT as a promising modality:5
- The percentage of patients with the ability to read at a distance increased from 28% at baseline to 97% post-surgery.
- There was no significant change to intraocular pressure or anterior chamber depth, and low impact on corneal endothelial cell density.
- Corneal edema was the most commonly reported complication in 22.9% of patients, and all adverse reactions were resolved by 6 months.
Clinical management and future outlook
Finding the right candidates for SING IMT requires collaboration and communication between Dr. Chin Yee, his surgical colleagues, and the patients themselves. He says they will do additional testing and counseling so that all involved have a clear understanding of expectations and risks.
With the rise of AMD diagnoses, it is still yet to be seen how this treatment might be implemented at a larger scale and how many patients will actually get the implant. There are also patients with geographic atrophy (GA) who have even fewer treatment options.
Conclusion
Overall, Drs. Chin Yee and Singh agree that the SING IMT is a promising technology with data supporting strong outcomes for patients with advanced AMD.
This article was written by Mariel Mohns, MS, based on the recorded video conversation between Drs. Singh and Chin Yee.
