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New treatment option for Age-Related Macular Degeneration
Official title Multicenter Clinical Study of the SING-IMT in Patients with Late-stage AMD
ClinicalTrials.gov ID: NCT05438732
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- 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...
- Have been monitored by an eye care professional over the 6-month (or longer) period immediately prior to the Pre-operative Visit and have...
- lack of need of treatment for CNV over the past 6 months, and
You likely can't join if
- Have cognitive impairment that would interfere with the ability to understand and provide Informed Consent or prevent proper visual...
- Have any of the following conditions at the Pre-operative Visit:
- Stargardt macular dystrophy;
- Diabetic retinopathy;
- Untreated retinal tears;
- Retinal vascular disease;
See the full eligibility criteria
Who can 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...
- 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
- 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...
- Have adequate peripheral vision at the Pre-operative Visit to allow navigation
What rules you out
- 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;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Loma Linda, California, United States
- Long Beach, California, United States
- Sarasota, Florida, United States
- Lawrence, Massachusetts, United States
- Birmingham, Michigan, United States
- Omaha, Nebraska, United States
- Eatontown, New Jersey, United States
- Asheville, North Carolina, United States
- Cleveland, Ohio, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Loma Linda, California, United States; Long Beach, California, United States; Sarasota, Florida, United States; Lawrence, Massachusetts, United States; Birmingham, Michigan, United States; Omaha, Nebraska, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.