Multicenter Clinical Study of the SING-IMT in Patients with Late-stage AMD

Part of paid clinical trials in Loma Linda, California.

Sponsor
VisionCare, Inc.
Study ID
NCT05438732
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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 Details

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).

Key Dates

Start date
Jun 16, 2022
Status verified
Nov 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
125 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: SING-IMT Implanted
    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

Primary Outcome Measure

Primary Effectiveness Outcome [ Time Frame: Approximately 12-months post-operatively (330-420 days) ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Loma Linda UniversityLoma LindaCalifornia92354
Rebecca Pereyra, Study Coordinator
[email protected]
+1 (909) 558--2168
Norlisha Borntrager, Study Director
[email protected]
+1 (909) 558-2233
Michael Rauser, MD
Eye Physicians of Long BeachLong BeachCalifornia90815
Lisa Bejarano, Study Coordinator
[email protected]
+1 (562) 799-2020
Carlos Martinez, MD
Sarasota Retina InstituteSarasotaFlorida34239
Peggy Jelemensky, Study Coordinator
[email protected]
+1 (941) 921-5335
Marc Levy, MD
Tallman Eye AssociatesLawrenceMassachusetts01841
Flor Flores, Study Coordinator
[email protected]
+1 (617) 470-5080
Justine St. Croix, VP of Operations
+1 (978) 688-6182
Tomasz Stryjewski, MD
Oakland Ophthalmic SurgeryBirminghamMichigan48009
Jessica Samuel, Study Coordinator
[email protected]
+1 (248) 644-8060
Timothy Page, MD
Vance Thompson VisionOmahaNebraska68137
Amanda Aparo, Study Coordinator
[email protected]
+1 (402) 506-9968
Tiffany Facile, MBA, MHA, BS, RN, Research Director
[email protected]
+1 (605) 371-7075
Brandon Baartman, MD
Atlantic Eye PhysiciansEatontownNew Jersey07724
Joseph Valeri, Study Coordinator
[email protected]
+1 (201) 705-7139
Ravi Patel, MD
Western Carolina Retinal AssociatesAshevilleNorth Carolina28803
Amy Moore, Study Coordinator
[email protected]
+1 (828) 258-1586
Lea Raymer, Director of Research
[email protected]
W. Zachery Bridges, Jr., MD
Cleveland Clinic | Cole Eye InstituteClevelandOhio44195
Jessica Wolfe, OD, MS, Research Coordinator
[email protected]
+1 (216) 445-5248
Aleksandra Rachitskaya, MD
Methodist Eye Associates | Houston MethodistHoustonTexas77030
Valentina Villarroel, Study Coordinator
[email protected]
+1 (346) 238-4384
Jennifer Garrett, BSN, CCRP, Clinical Trials Manager
[email protected]
+1 (346) 238-4516
Rahul Pandit, MD

Find similar trials in Loma Linda, CA

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
Loma Linda University· Loma Linda, CAEye Physicians of Long Beach· Long Beach, CASarasota Retina Institute· Sarasota, FLTallman Eye Associates· Lawrence, MAOakland Ophthalmic Surgery· Birmingham, MIVance Thompson Vision· Omaha, NE

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