Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration

Part of paid clinical trials in Manchester, Connecticut.

Sponsor
i-Lumen Scientific AUS PTY LTD
Study ID
NCT06662162
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • i-Lumen AMD — DEVICE
    i-Lumen AMD transpalpebral microcurrent stimulation system

Study Details

The goal of this clinical trial is to characterize the safety and effectiveness of the i-Lumen AMD transpalpebral microcurrent device and therapy in patients with intermediate to advanced nonexudative AMD. Participants will: * Undergo an initial loading regimen, followed by 7 maintenance over the course of 11 months. * Participants will return monthly through Month 14 (3 months post-last treatment) for evaluation and monitoring.

Key Dates

Start date
May 7, 2025
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active i-Lumen AMD therapy
    Active transpalpebral microcurrent therapy
  • Sham Comparator: Sham i-Lumen AMD therapy
    Sham transpalpebral microcurrent therapy

Primary Outcome Measure

Mean Change BCVA from Baseline [ Time Frame: Month 3 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Retina Consultants PCManchesterConnecticut06042
Chris Research Coordinator
[email protected]
860-646-7704 x113
Noam Rudnick, MD (PRINCIPAL_INVESTIGATOR)
University Retina & Macula AssociatesLemontIllinois60439
Clinical Research Manager
[email protected]
708-765-4110
Texas Retina AssociatesFort WorthTexas76104
Lori Research Coordinator
[email protected]
817-334-0882 x411
Patrick Williams, MD (PRINCIPAL_INVESTIGATOR)
Tyler Retina Research InsituteTylerTexas75703
Melissa Long Research Coordinator
[email protected]
903-597-4644
Samuel Minaker, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Manchester, CT

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
Retina Consultants PC· Manchester, CTUniversity Retina & Macula Associates· Lemont, ILTexas Retina Associates· Fort Worth, TXTyler Retina Research Insitute· Tyler, TX

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