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New treatment option for AMD
Official title Post-market Clinical Investigation of the SING IMT System, Model NG SI IMT 3X in Patients With End-stage Age-related Macular Degeneration
ClinicalTrials.gov ID: NCT04796545
What this study is testing
- What it's testing
- The objective of this study is to demonstrate the safety and effectiveness of the SING IMT (Smaller Incision New Generation Implantable Miniature Telescope) 3X implant in improving vision in patients with central vision impairment associated with end-stage Age-related Macular Degeneration (AMD). Eligible patients will be implanted with the SING IMT device and will be followed-up for a period of 12-months with post-operative ophthalmic exams and low-vision rehabilitation sessions.
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 and older
You may be able to join if
- Be 55 years of age or older.
- Have retinal findings of geographic atrophy or disciform scar with foveal involvement as determined by fluorescein angiography or OCT.
- Have evidence of cataract.
- Have best-corrected distance visual acuity (BCDVA) no better than 20/80 (0.6 LogMAR) and no worse than 20/800 (1.6 LogMAR) in both eyes.
- Have adequate peripheral vision in the eye not scheduled for surgery, assessed by observation of ambulation.
You likely can't join if
- Evidence of active choroidal neovascularization (CNV) on fluorescein angiography or OCT or were treated for CNV within the past six months.
- Any ophthalmic pathology that compromises the patient's peripheral vision in the fellow eye.
- A history of steroid-responsive rise in IOP, uncontrolled glaucoma, or preoperative IOP\>22 mm Hg.
- Corneal guttata.
- Known sensitivity to post-operative medications.
- Significant communication impairment or severe neurological disorders.
See the full eligibility criteria
- Be 55 years of age or older.
- Have retinal findings of geographic atrophy or disciform scar with foveal involvement as determined by fluorescein angiography or OCT.
- Have evidence of cataract.
- Have best-corrected distance visual acuity (BCDVA) no better than 20/80 (0.6 LogMAR) and no worse than 20/800 (1.6 LogMAR) in both eyes.
- Have adequate peripheral vision in the eye not scheduled for surgery, assessed by observation of ambulation.
- Achieve at least a five-letter improvement on the ETDRS chart in the eye scheduled for surgery when using Samsara's 2.8X external telescope simulator (ETS, supplied separately).
- Have an ACD of at least 2.5 mm in the eye scheduled for surgery.
- Be willing to participate in a post-operative training program for the use of the NG SI IMT 3X implant.
- Review and sign the Independent Ethics Committee (IEC)-approved Informed Consent Form (ICF) prior to any study-related procedures being performed.
- Have adequate understanding of the local language to understand verbal and written subject information and be willing to comply with the study requirements.
- Evidence of active choroidal neovascularization (CNV) on fluorescein angiography or OCT or were treated for CNV within the past six months.
- Any ophthalmic pathology that compromises the patient's peripheral vision in the fellow eye.
- A history of steroid-responsive rise in IOP, uncontrolled glaucoma, or preoperative IOP\>22 mm Hg.
- Corneal guttata.
- Known sensitivity to post-operative medications.
- Significant communication impairment or severe neurological disorders.
- Have undergone previous intraocular or corneal surgery of any kind in the operative eye, including any type of surgery for either refractive or therapeutic purposes.
- An ocular condition that predisposes the patient to eye rubbing.
- Prior or expected ophthalmic-related surgery within 30 days preceding the NG SI IMT 3X implant surgery.
- Patients for whom the planned operative eye has:
- Myopia \> 6.0 D
- Hyperopia \> 4.0 D
- Axial length \< 21 mm
- Endothelial cell density \< 1600 cells per square mm
- Narrow angle, i.e., \< Schaffer grade 2.
- Inflammatory ocular disease.
- Cornea stromal or endothelial dystrophies, including guttata.
- Zonular weakness/instability of crystalline lens, or pseudoexfoliation.
- Diabetic retinopathy.
- Untreated retinal tears.
- Retinal vascular disease.
- Optic nerve disease.
- A history of retinal detachment.
- Retinitis pigmentosa.
- Intraocular tumor.
- Have received any investigational product within 30 days prior to study enrollment or be planning to participate in another investigation during the course of this study.
- Be an employee (or a relative of an employee) of the contract research organization (CRO) responsible for conducting the study, Sponsor, or Sponsor representative.
- Have a condition or be in a situation that, in the Investigator's opinion, may put the Subject at significant risk, may confound the study results, or may interfere significantly with the Subject's participation in the...
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Belgium
- Marseille, France
- Saint-Jean-de-Luz, France
- Strasbourg, France
- Karlsruhe, Germany
- Münster, Germany
- Dublin, Ireland
- Naples, Italy
- Roma, Italy
- Alicante, Spain
- Barcelona, Spain
- Madrid, Spain
- Belfast, United Kingdom
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 study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brussels, Belgium; Marseille, France; Saint-Jean-de-Luz, France; Strasbourg, France; Karlsruhe, Germany; Münster, Germany and 7 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.