Age-Related Macular Degeneration study: Smaller incision
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
- This study aims to find out if a new, smaller implantable telescope is safe and effective for improving central vision loss.
- Who it's for
- The study is looking for people with late-stage age-related macular degeneration who have moderate to severe central vision loss.
- What's involved
- Participants will receive a small, implantable telescope in their eye to help with central vision.
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...
- 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
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...
- Stargardt macular dystrophy;
- Diabetic retinopathy;
- Untreated retinal tears;
- Retinal vascular disease;
- Optic nerve disease;
See the full eligibility criteria
- 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;
- 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
- Have evidence of visually significant cataract at the Pre-operative Visit;
- Have adequate peripheral vision at the Pre-operative Visit to allow navigation
- Have cognitive impairment that would interfere with the ability to understand and provide Informed Consent or prevent proper visual training/rehabilitation with the device;
- 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;
- 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;
- 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 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 is enrolling
- 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, but 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?
This study is enrolling now at 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 locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.