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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

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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: AU-011-301

Condition: Primary Indeterminate Lesions and Small Choroidal Melanoma

Eligible Subjects will be assigned into one of three treatment arms:

Arm 1: AU-011 dose of 80μg delivered via 2 suprachoroidal injections
(administered 30 minutes to 2 hours apart) of 40 μg in 100 μg for each injection
followed by 2 laser applications 4-6 hours after the second suprachoroidal injection. The
laser applications will be administered 30 + 15 minutes apart.

Arm 2: AU-011 dose of 40μg delivered via 2 suprachoroidal injections
(administered 30 minutes to 2 hours apart) of 20 μg in 100 μg for each injection
followed by 2 laser application 4-6 hours after the second suprachoroidal injection. The
laser applications will be administered 30 + 15 minutes apart.

Arm 3: 2 sham injections (administered 30 minutes to 2 hours apart) will be
applied with a needleless microinjector followed by 2 sham laser applications 4-6 hours
after the second suprachoroidal injection. The laser applications will be administered 30
+ 15 minutes apart.

Final Visit for all arms: Week 104 Day 278 +/- 14 Days

Sponsor: Aura Biosciences, Inc.

Additional information about this trial is available at http://www.ClinicalTrials.gov.

Royal Oak Site:

Principal Investigator: Antonio Capone, Jr., MD

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: OTX-TKI-2023-AMD-303

Condition: Treatment Naïve Neovascular Age-Related Macular Degeneration or Neovascular Age-Related Macular Regeneration Diagnosed within 4 months prior to screening.

Participant Group/Arm Intervention/Treatment Experimental: OTX-TKI Re-dose
Drug: OTX-TKI • Intravitreal Injection of OTX-TKI

Active Comparator: Aflibercept 2mg on label
Drug: Aflibercept • Intravitreal Injection of 2mg of aflibercept

Other: Aflibercept 8mg high dose
Drug: Aflibercept • Intravitreal Injection of 8mg of aflibercept

Sponsor: Ocular Therapeutix, Inc.

Royal Oak Site:

Principal Investigator: Lisa J. Faia, M.D

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