Age-Related Macular DegenerationCONCERTONCT05438732
Multicenter Clinical Study of the SING-IMT in Patients with Late-stage AMD
A study testing smaller incision, new generation implantable miniature telescope (SING-IMT) in people with Age-Related Macular Degeneration and Geographic Atrophy, run by VisionCare, Inc. at 10 sites in United States.
Trial summary
The objective of this study is to determine the safety and effectiveness of the smaller incision, new generation (SING), implantable miniature telescope (IMT) in patients with moderate-severe central vision loss due to late-stage age-related macular degeneration (AMD). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Age-Related Macular Degeneration, Geographic Atrophy
- What is being tested?
- smaller incision, new generation implantable miniature telescope (SING-IMT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 10 sitesUnited States
- Study dates
- 16 Jun 2022to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Be at least 65 years of age at the Pre-operative Visit;
- Have ETDRS BCDVA 0.9 to 1.6 logMAR (20/160 to 20/800) at the Pre-operative Visit caused by bilateral central scotomas associated with end-stage AMD;
- Have bilateral retinal findings of geographic atrophy or disciform scar with foveal involvement, as determined by standard of care fluorescein angiography (FA) prior to the Pre-operative Visit;
- Have been monitored by an eye care professional over the 6-month (or longer) period immediately prior to the Pre-operative Visit and have demonstrated no evidence of active choroidal neovascularization (CNV) prior to the Pre-operative Visit as demonstrated by the following:
- lack of need of treatment for CNV over the past 6 months, and
- lack of active exudative fluid on optical coherence tomography (OCT) over the past 6 months, and
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- lack of Retinal hemorrhage on exam over a 6-month period or longer
- Agree to participate in post-operative visual training
- For the Implanted Eye:
- Have evidence of visually significant cataract at the Pre-operative Visit;
- Agree to undergo pre-operative training and assessment (1 or more sessions) with low vision specialists (optometrist or occupational therapist) in the use of an external telescope model sufficient for patient assessment and patient must achieve at least a 5-letter ETDRS BCDVA improvement (0.1 logMAR) in the final assessment
- For the Non-Implanted Eye:
- Have adequate peripheral vision at the Pre-operative Visit to allow navigation
Who cannot join
- Have cognitive impairment that would interfere with the ability to understand and provide Informed Consent or prevent proper visual training/rehabilitation with the device;
- Have any of the following conditions at the Pre-operative Visit:
- Stargardt macular dystrophy;
- Diabetic retinopathy;
- Untreated retinal tears;
- Retinal vascular disease;
Show all 32Show fewer
- 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
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Western Carolina Retinal Associates
Asheville, North Carolina, 28803
Amy Moore, Study Coordinator, +1 (828) 258-1586 ext. 2505, amoore@aea1961.com
Lea Raymer, Director of Research, ldoll@aea1961.com
- Recruiting
Oakland Ophthalmic Surgery
Birmingham, Michigan, 48009
Jessica Samuel, Study Coordinator, +1 (248) 644-8060, jessicasamuel@eyecare-partners.com
Timothy Page, MD
- Recruiting
Cleveland Clinic | Cole Eye Institute
Cleveland, Ohio, 44195
Jessica Wolfe, OD, MS, Research Coordinator, +1 (216) 445-5248, wolfej11@ccf.org
Aleksandra Rachitskaya, MD
- Recruiting
Atlantic Eye Physicians
Eatontown, New Jersey, 07724
Joseph Valeri, Study Coordinator, +1 (201) 705-7139, jdvaleri@gmail.com
Ravi Patel, MD
- Recruiting
Methodist Eye Associates | Houston Methodist
Houston, Texas, 77030
Valentina Villarroel, Study Coordinator, +1 (346) 238-4384, vvillarroel@houstonmethodist.org
Jennifer Garrett, BSN, CCRP, Clinical Trials Manager, +1 (346) 238-4516, jmgarrett@houstonmethodist.org
- Recruiting
Tallman Eye Associates
Lawrence, Massachusetts, 01841
Flor Flores, Study Coordinator, +1 (617) 470-5080, Research@tallmaneye.com
Justine St. Croix, VP of Operations, +1 (978) 688-6182 ext. 1170
- Recruiting
Loma Linda University
Loma Linda, California, 92354
Rebecca Pereyra, Study Coordinator, +1 (909) 558--2168 ext. 22168, rpereyra@llu.edu
Norlisha Borntrager, Study Director, +1 (909) 558-2233 ext. 22230, NBorntrager@llu.edu
- Recruiting
Eye Physicians of Long Beach
Long Beach, California, 90815
Lisa Bejarano, Study Coordinator, +1 (562) 799-2020, lisab@eplb.com
Carlos Martinez, MD
- Recruiting
Vance Thompson Vision
Omaha, Nebraska, 68137
Amanda Aparo, Study Coordinator, +1 (402) 506-9968, amanda.aparo@vancethompsonvision.com
Tiffany Facile, MBA, MHA, BS, RN, Research Director, +1 (605) 371-7075, tiffany.facile@vancethompsonvision.com
- Recruiting
Sarasota Retina Institute
Sarasota, Florida, 34239
Peggy Jelemensky, Study Coordinator, +1 (941) 921-5335 ext. 232, SRQresearch@aol.com
Marc Levy, MD
About this study
Official title: A Prospective, Multicenter Clinical Study of the Implantable Miniature Telescope, Model SING in Patients with Central Vision Impairment Associated with End-stage Age-related Macular Degeneration (AMD)
The objective of this study is to determine the safety and effectiveness of the smaller incision, new generation (SING), implantable miniature telescope (IMT) in patients with moderate-severe central vision loss due to late-stage age-related macular degeneration (AMD).
Read the detailed description
Following completion of informed consent, patients will be evaluated for eligibility to enroll into the study, including assessment of their best-corrected distance- and near- visual acuity with and without refraction, and also when using an external telescope simulator (ETS) to determine if they are likely to benefit from receiving the IMT. If eligible, they will be scheduled for out-patient surgery to implant the IMT during routine cataract surgery. Following implantation, patients will return for 5 post-operative follow-up visits over a period of approximately 12 months. Additionally, patients will have up to 12 rehabilitation/training visits with a low vision specialist
- Being tested
- smaller incision, new generation implantable miniature telescope (SING-IMT)
- Keywords
- cataract, best-corrected distance visual acuity
- Medical subject headings
- Macular Degeneration, Geographic Atrophy, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smaller incision, new generation implantable miniature telescope (SING-IMT)Device
The IMT (model SING) is an intraocular implant comprised of 2 micro lenses in a glass tube (optics) in a flexible silicone carrier (haptics)
| Study group | Role | What they receive |
|---|---|---|
| SING-IMT Implanted | Experimental | 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 Receives: Device: smaller incision, new generation implantable miniature telescope (SING-IMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Outcome
Proportion of study eyes with an improvement of 10 or more ETDRS letters (0.2 logMAR) in either BCDVA or BCNVA at Visit 5 (330 to 420 days post-operatively) compared to Pre-operative Visit
Measured: Approximately 12-months post-operatively (330-420 days)
Primary Safety Outcome
Percent change in endothelial cell density (ECD) from Pre-operative Visit in study eyes at Visit 5 (330 to 420 days post-operatively)
Measured: Approximately 12-months post-operatively (330-420 days)
Secondary outcomes (6)
Best-corrected distance visual acuity (BCDVA)
Post-operative BCDVA in study eyes at Visit 5 (330 to 420 days post-operatively) compared to Pre-operative Visit
Measured: Approximately 12-months post-operatively (330-420 days)
Best-corrected near visual acuity (BCNVA)
Post-operative BCNVA in study eyes at Visit 5 (330 to 420 days post-operatively) compared to Pre-operative Visit
Measured: Approximately 12-months post-operatively (330-420 days)
Anterior Chamber Depth
Anterior Chamber Depth in study eyes, defined as the distance between the corneal endothelium and the front surface of the IMT, at Visit 5 (330 to 420 days post-operatively)
Measured: Approximately 12-months post-operatively (330-420 days)
IMT position
IMT tilt and centration in study eyes at Visit 5 (330 to 420 days post-operatively)
Measured: Approximately 12-months post-operatively (330-420 days)
Adverse Events
Rates of adverse events from Operative Visit through Visit 5 (330 to 420 days post-operatively)
Measured: Approximately 12-months post-operatively (330-420 days)
Posterior Capsule Opacification
Rates of posterior capsule opacification in study eyes at post-operative visit 5 (330 to 420 days post-operatively)
Measured: Approximately 12-months post-operatively (330-420 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start16 Jun 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Effectiveness: one-sided asymptotic normal test Safety: one-sided t-test
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VisionCare, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Responsible party
- Sponsor
- Investigators
- Rebecca J Kammer, OD, PhD, Study director, Samsara Vision Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438732
- Sponsor's protocol ID
- CDV-SNG-21-001
- Acronym
- CONCERTO
- Status last verified
- Nov 2024
- First submitted
- 24 Jun 2022
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Clinical Study of the Implantable Miniature Telescope, Model SING in Patients with Central Vision Impairment Associated with End-stage Age-related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT05438732
- Acronym / sponsor ID
- CONCERTO / CDV-SNG-21-001
- Keywords
- cataract, best-corrected distance visual acuity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- VisionCare, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine the safety and effectiveness of the smaller incision, new generation (SING), implantable miniature telescope (IMT) in patients with moderate-severe central vision loss due to late-stage age-related macular degeneration (AMD).
Detailed description
Following completion of informed consent, patients will be evaluated for eligibility to enroll into the study, including assessment of their best-corrected distance- and near- visual acuity with and without refraction, and also when using an external telescope simulator (ETS) to determine if they are likely to benefit from receiving the IMT. If eligible, they will be scheduled for out-patient surgery to implant the IMT during routine cataract surgery. Following implantation, patients will return for 5 post-operative follow-up visits over a period of approximately 12 months. Additionally, patients will have up to 12 rehabilitation/training visits with a low vision specialist
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Effectiveness: one-sided asymptotic normal test Safety: one-sided t-test
| Arm | Type | Receives |
|---|---|---|
| SING-IMT Implanted | Experimental | Device: smaller incision, new generation implantable miniature telescope (SING-IMT)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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (13 listed)
- Be at least 65 years of age at the Pre-operative Visit;
- Have ETDRS BCDVA 0.9 to 1.6 logMAR (20/160 to 20/800) at the Pre-operative Visit caused by bilateral central scotomas associated with end-stage AMD;
- Have bilateral retinal findings of geographic atrophy or disciform scar with foveal involvement, as determined by standard of care fluorescein angiography (FA) prior to the Pre-operative Visit;
- Have been monitored by an eye care professional over the 6-month (or longer) period immediately prior to the Pre-operative Visit and have demonstrated no evidence of active choroidal neovascularization (CNV) prior to the Pre-operative Visit as demonstrated by the following:
- Agree to participate in post-operative visual training
Key exclusion criteria (32 listed)
- Have cognitive impairment that would interfere with the ability to understand and provide Informed Consent or prevent proper visual training/rehabilitation with the device;
- Have any of the following conditions at the Pre-operative Visit:
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smaller incision, new generation implantable miniature telescope (SING-IMT)The IMT (model SING) is an intraocular implant comprised of 2 micro lenses in a glass tube (optics) in a flexible silicone carrier (haptics) | Device | SING-IMT Implanted |
Primary outcome
Primary Effectiveness Outcome
Time frame: Approximately 12-months post-operatively (330-420 days)
Proportion of study eyes with an improvement of 10 or more ETDRS letters (0.2 logMAR) in either BCDVA or BCNVA at Visit 5 (330 to 420 days post-operatively) compared to Pre-operative Visit
Primary Safety Outcome
Time frame: Approximately 12-months post-operatively (330-420 days)
Percent change in endothelial cell density (ECD) from Pre-operative Visit in study eyes at Visit 5 (330 to 420 days post-operatively)
6 secondary outcomes
Best-corrected distance visual acuity (BCDVA)
Time frame: Approximately 12-months post-operatively (330-420 days)
Best-corrected near visual acuity (BCNVA)
Time frame: Approximately 12-months post-operatively (330-420 days)
Anterior Chamber Depth
Time frame: Approximately 12-months post-operatively (330-420 days)
IMT position
Time frame: Approximately 12-months post-operatively (330-420 days)
Adverse Events
Time frame: Approximately 12-months post-operatively (330-420 days)
Posterior Capsule Opacification
Time frame: Approximately 12-months post-operatively (330-420 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rebecca J Kammer, OD, PhD study director
Samsara Vision Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smaller incision, new generation implantable miniature telescope (SING-IMT) in people with Age-Related Macular Degeneration and Geographic Atrophy, run by VisionCare, Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Kammer, OD, PhD (+1 (714) 728-1575, rkammer@samsaravision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Outcome (time frame: Approximately 12-months post-operatively (330-420 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.