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Retinal & Macular Disease Clinical Trials in Michigan

The physicians at Associated Retinal Consultants (ARC) sponsor research devoted to the advancement of medical and surgical care of retinal and macular diseases. Collaborative studies are performed with the National Institute of Health, the pharmaceutical industry, and other national and international institutions.

An independent Investigational Review Board (IRB) reviews all proposed research studies to ensure the efficacy and safety of protocols and treatment. IRB approval is required before a new study is conducted.

Royal Oak, Michigan

Beaumont Neuroscience Center Building
3555 W. 13 Mile Road
Suite LL-20
Royal Oak, MI 48073

Phone: 248-288-9132
Fax: 248-288-2265

Grand Rapids, Michigan

1179 East Paris S.E.
Suite 250
Grand Rapids, MI 49546

Phone: 616-942-2406
Fax: 616-942-1165

Traverse City, Michigan

860 East Front Street
Traverse City, MI 49686

Phone: 231-938-0710
Fax: 231-938-0264

Current Enrolling Studies

Protocol Number: RGX-314-5101 (also known as M23-422)

Condition: Neovascular age-related macular degeneration (nAMD)

Eligible subjects will be followed prospectively from the time of enrollment until the end
of study, 5 years post-ABBV-RGX-314 administration (inclusive of the parent study) in
their study eye, for data collection. After enrollment, subjects will attend a 6-month
follow-up visit and will attend at least annual study visits through the end of the 5-year
post- ABBV-RGX-314 administration follow-up period.

Final Visit: Maximum follow-up period of 5 years post-ABBV-RGX-314 administration
(inclusive of the parent study) in their study eye.

Sponsor: AbbVie Inc.

Royal Oak Site:

Principal Investigator: Jeremy D. Wolfe, M.D.

Protocol Number: ML43000

Condition: Neovascular Age-Related Macular Degeneration

Eligible subjects will have the implant device (filled prior to implantation
with approximately 20 μL of the 100-mg/mL formulation of ranibizumab [approximately 2-mg
dose of ranibizumab]) surgically inserted in the study eye on Day 1 following the
enrollment visit. Subjects will receive implant refill-exchanges at fixed 24-week
intervals.

Final Visit: Week 52

Sponsor: Genentech, Inc.

Royal Oak Site:

Principal Investigator: Jeremy D. Wolfe, M.D.

Protocol Number: AU-011-401

Condition: Primary Choroidal Melanoma (CM) or Indeterminate Lesions (ILS)

Eligible Subjects will participate in the Registry following completion of or withdrawal from participation in an Aura sponsored clinical trial for primary choroidal melanoma (CM) or indeterminate lesions (IL).

Final Visit: A minimum of 5 years (including time enrolled in an Aura sponsored clinical trial), until withdrawal of consent, or until death whichever comes first.

Sponsor: Aura Biosciences, Inc.

Royal Oak Site:

Principal Investigator: Antonio Capone Jr., M.D.

Protocol Number: MacTel NHOR

Condition: Macular Telangiectasia Type 2

The study will develop a registry of patients with macular telangiectasia type 2 who may agree to be contacted for inclusion in future clinical trials.

Participants who meet the study eligibility criteria will be enrolled in the registry and will be seen for one clinic visit and, if they agree, they will be contacted at least annually for updates on their health.

Sponsor: The Lowy Medical Research Institute.

Principle Investigator:

Sandeep Randhawa, M.D. (Royal Oak)

Paul V. Raphaelian, M.D. (Grand Rapids)

Scott R. Sneed, M.D. (Traverse City)

Status:  Enrolling

Protocol Number: OSC/SS

Condition: Stickler Syndrome

Eligible subjects at high risk of retinal detachment will receive standard of care
prophylactic laser retinopexy. All visits will be conducted as standard of care with
prospective data collected.

Final Visit: Month 60

Sponsor: Helen Keller Eye Research Foundation

Royal Oak Site: Principal Investigator: Matthew G. Trese, D.O.

Protocol Number: TITAN R7041-NIU-24123

Condition: Posterior Segment NonInfectious Uveitis

Eligible Subjects will be assigned into one of two study parts:

Part A: Single intravitreal injection of REGN7041 in one of six cohorts (Cohort 1 dose level 1, Cohort 2 dose level 2, Cohort 3 dose level 3, Cohort 4 dose level 4, Cohort 5 dose level 5, Cohort 6 dose level 6) on day 1.  Safety follow up assessment will occur day 4 through week 16 at specific  intervals.

Part B: Three intravitreal injections of REGN7041 at one of three dose levels (Cohort 1 dose level 1, Cohort 2 dose level 2, Cohort 3 dose level 3 (optional) determined from Part A. Safety Follow up assessment will occur day 4 through week 24 at specific intervals. 

Final Visit: Part A Week 16

                  Part B Week 24

Sponsor: Regeneron Pharmaceuticals, Inc.

Royal Oak Site: Principal Investigator: Lisa J. Faia, M.D.

Protocol Number: ILS-AMD-202 / i-SIGHT2

Condition: Intermediate to Advanced Nonexudative Age-Related Macular Degeneration

The i-SIGHT2 study will assess the safety and effectiveness of the i-Lumen AMD microcurrent electrical stimulation study device and see how long-term study treatments may affect study participants that have vision loss due to intermediate to advanced dry AMD.  The i-Lumen AMD study device is an in-office, noninvasive investigational medical devices that delivers microcurrent (low level) electrical stimulation to an electrode that is placed on the closed upper eyelid.

Eligible participants will be assigned to either active or sham (placebo) therapy session.  Eligible participants will complete an initial 5-day in-office regimen, and will then return for follow-up Visits at Week 2, and then monthly through Month 24.  During the Follow-up period, 13 visits will include a single day of therapy sessions over the 24-month period.

Final Visit:  24 months

Sponsor: i-Lumen Scientific AUS Pty Ltd / Manufacturer: i-Lumen Scientific, Inc.

Royal Oak Site: Principal Investigator: Jeremy D. Wolfe, M.D.