SING-IMT for Late-Stage Age-Related Macular Degeneration
(CONCERTO Trial)
Recruiting in Palo Alto (17 mi)
+16 other locations
Age: 65+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VisionCare, Inc.
Disqualifiers: Cognitive impairment, Diabetic retinopathy, Glaucoma, others
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This trial tests a tiny telescope implanted in the eye to help people with severe vision loss from late-stage AMD. The telescope magnifies images to improve vision by using healthy parts of the eye.
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 team or your doctor.
What data supports the effectiveness of the treatment SING-IMT for late-stage age-related macular degeneration?
Research shows that implantable miniature telescopes (IMT) have been effective in improving vision for patients with age-related macular degeneration, with studies reporting both medium-term and long-term benefits in visual acuity (sharpness of vision).
12345Is the SING-IMT treatment safe for humans?
The SING-IMT has been studied for safety in patients with age-related macular degeneration, showing that it generally has a good safety profile. In a study, the most common issue was corneal edema (swelling of the clear front part of the eye), but overall, it showed lower cell loss in the eye compared to the first-generation device.
12356How is the SING-IMT treatment different from other treatments for late-stage age-related macular degeneration?
The SING-IMT treatment is unique because it involves implanting a miniature telescope inside the eye, which helps improve vision by directing light to healthy parts of the retina. This approach is different from other treatments that typically involve injections or medications.
12357Eligibility Criteria
This trial is for people aged 65 or older with late-stage age-related macular degeneration (AMD) causing severe vision loss. Participants must have stable AMD without recent bleeding or active fluid in the retina, and be monitored by an eye doctor for at least 6 months. They should not have cognitive impairments that affect training for a new visual device, significant myopia/hyperopia, previous eye surgeries, uncontrolled glaucoma, or allergies to post-op meds.Inclusion Criteria
I haven't needed treatment for CNV in the last 6 months.
I agree to attend training with a vision specialist to use a special telescope and improve my reading ability.
My vision is between 20/160 and 20/800 due to AMD.
+11 more
Exclusion Criteria
Have cognitive impairment that would interfere with the ability to understand and provide Informed Consent or prevent proper visual training/rehabilitation with the device
For the Implanted Eye: Have central anterior chamber depth (ACD) <3.0 mm from the posterior surface of the cornea (endothelium) to the anterior surface of the crystalline lens at the Pre-operative Visit, Have an Endothelial Cell Density (ECD) below: 2,000 cells per millimeter, if 65-84 years old, 1,800 cells per millimeter, if 85 years old or greater (based on the lowest value of the three cell counts performed by technician at investigative site at the Pre-operative Visit), Have a history of corneal stromal or endothelial dystrophies, including guttata, Have Myopia > 6.0 D or Hyperopia > 4.0 D by Manifest Refraction at the Pre-operative Visit, Have an Axial Length (AL) < 21 mm at the Pre-operative Visit, Have a narrow angle defined as < grade 2 on the Schaffer scale at the Pre-operative Visit, Ongoing Inflammatory ocular disease at the Pre-operative Visit, Zonular weakness/instability of crystalline lens, or pseudoexfoliation at the Pre-operative Visit, Have any condition at the Pre-operative Visit which in the judgement of the Investigator indicates that the haptics cannot be placed within the capsular bag during surgery, Have had previous intraocular or corneal surgery, including any type of surgery for refractive or therapeutic purposes, For the Non-Implanted Eye: Have ophthalmic pathology at the Pre-operative Visit that compromises the patient's peripheral vision based on the Investigator's judgment.
Have any of the following conditions at the Pre-operative Visit: Stargardt macular dystrophy, Diabetic retinopathy, Untreated retinal tears, Retinal vascular disease, Optic nerve disease, History of retinal detachment, Intraocular tumor, Retinitis pigmentosa, History of steroid-induced rise in intraocular pressure (IOP), uncontrolled glaucoma, or IOP >22 mmHg at the Pre-operative Visit, Have known allergy to post-operative medications, History of eye rubbing or an ocular condition that predisposes subject to eye rubbing, Have had prior or expected ophthalmic surgery within 30 days of the Operative Visit, Have any circumstance that, based on the Investigator's judgment, poses a concern for the subject's safety, Any systemic disease or clinical evidence of any condition at the Pre-operative Visit which would make the subject in the opinion of the investigator unsuitable for the study, Concurrent participation or prior participation in any investigative drug or device study within last 30 days prior to Pre-operative Visit
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Treatment
Participants undergo out-patient surgery to implant the SING-IMT during routine cataract surgery
1 day
1 visit (in-person)
Post-operative Follow-up
Participants return for 5 post-operative follow-up visits to monitor safety and effectiveness
12 months
5 visits (in-person)
Rehabilitation/Training
Participants have up to 12 rehabilitation/training visits with a low vision specialist
12 months
Up to 12 visits (in-person)
Participant Groups
The study tests a smaller incision implantable miniature telescope (SING-IMT) designed to improve central vision in patients with severe vision loss from AMD. It involves pre-operative training with low vision specialists and post-operative visual training to adapt to the device.
1Treatment groups
Experimental Treatment
Group I: SING-IMT ImplantedExperimental Treatment1 Intervention
the implanted eye will be the study eye which receives the SING-IMT. Implantation will occur during routine cataract surgery using a proprietary delivery system (loading cartridge and injector), via an approximately 6.5mm incision
SING-IMT is already approved in European Union, China for the following indications:
🇪🇺 Approved in European Union as SING IMT for:
- Late-stage age-related macular degeneration (AMD)
🇨🇳 Approved in China as SING IMT for:
- Late-stage age-related macular degeneration (AMD)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Eye Physicians of Long BeachLong Beach, CA
Oakland Ophthalmic SurgeryBirmingham, MI
Vance Thompson VisionOmaha, NE
Atlantic Eye PhysiciansEatontown, NJ
More Trial Locations
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Who Is Running the Clinical Trial?
VisionCare, Inc.Lead Sponsor
ORA, Inc.Industry Sponsor
References
Long-term (60-month) results for the implantable miniature telescope: efficacy and safety outcomes stratified by age in patients with end-stage age-related macular degeneration. [2020]The purpose of this study was to evaluate the long-term results of an implantable miniature telescope (IMT) in patients with bilateral, end-stage, age-related macular degeneration (AMD).
Anti-vascular endothelial growth factor injection technique for recurrent exudative macular degeneration in a telescope-implanted eye. [2015]To describe the management of a patient with neovascular age-related macular degeneration and an implantable miniature telescope.
Medium-term results of implantable miniaturized telescopes in eyes with age-related macular degeneration. [2019]To evaluate the efficacy of an implantable miniaturized telescope, the IMT, in patients with age-related macular degeneration (ARMD).
Intraocular telescopic lens evaluation in patients with age-related macular degeneration. [2022]To evaluate the improvement of distance and near visual acuity after removal of cataract and implantation of an 3.0x intraocular miniaturized telescope (IMT) in patients with stable atrophic type age-related macular degeneration (ARMD).
The Implantable Miniature Telescope for macular degeneration. [2007]The function is described of the Implantable Miniature Telescope, which is completing clinical development for bilateral end-stage macular degeneration, and 6-month results of the Phase II/III IMT002 prospective, multicenter study are presented. Multispecialty patient management and implications of the study's findings are discussed.
Three-Month Safety and Efficacy Outcomes for the Smaller-Incision New-Generation Implantable Miniature Telescope (SING IMT™). [2023]The smaller-incision new-generation implantable miniature telescope (SING IMT™) is the second generation of the IMT™, a telescope prosthesis that is indicated for monocular implantation in patients with stable vision impairment caused by bilateral central scotomas associated with end-stage Age-related macular degeneration (AMD). This non-comparative retrospective study is the first and largest single-surgeon case series to evaluate the short-term (3 months) safety and efficacy of the device in patients with disciform scars or geographic atrophy at baseline. The main outcome measures included best-corrected distance and near visual acuity (CDVA and CDNVA, respectively), endothelial cell density (ECD) loss, and the incidence of complications. At postoperative month 3 in the study eyes, mean CDVA and CDNVA improved by +14.9 ± 7.1 letters and +7.7 ± 3.2 Jaeger levels, respectively. Importantly, 70.83% of patients gained ≥ 2 lines, 58.33% ≥ 3 lines, and 25.00% ≥ 4 lines of CDVA. From baseline, ECD loss in the study eyes was 10.4 ± 13.3% at 3 months, however, ECD was comparable between the study and fellow eyes at all time points. The most common complication was corneal edema. In all, these short-term outcomes suggest that the SING IMT™ delivers lower ECD loss than the first-generation IMT ™, but similar visual outcomes and safety.
Optical-Quality Assessment of a Miniaturized Intraocular Telescope. [2023]Age-related macular degeneration (AMD) causes severe vision impairments, including blindness. An option to improve vision in AMD patients is through intraocular lenses and optics. Among others, implantable miniaturized telescopes, which direct light to healthy lateral regions of the retina, can be highly effective in improving vision in AMD patients. Yet, the quality of the restored vision might be sensitive to the optical transmission and aberrations of the telescope. To shed light on these points, we studied the in vitro optical performance of an implantable miniaturized telescope, namely, the SING IMT™ (Samsara Vision Ltd., Far Hills, NJ, USA) designed to improve vision in patients affected by late-stage AMD. Specifically, we measured the optical transmission in the spectral range 350-750 nm of the implantable telescope with a fiber-optic spectrometer. Wavefront aberrations were studied by measuring the wavefront of a laser beam after passing through the telescope and expanding the measured wavefront into a Zernike polynomial basis. Wavefront concavity indicated that the SING IMT™ behaves as a diverging lens with a focal length of -111 mm. The device exhibited even optical transmission in the whole visible spectrum and effective curvature suitable for retinal images magnification with negligible geometrical aberrations. Optical spectrometry and in vitro wavefront analysis provide evidence supporting the feasibility of miniaturized telescopes as high-quality optical elements and a favorable option for AMD visual impairment treatments.