AAA

Current Research Studies

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.

The following is a list of currently enrolling studies:

Title: A Natural History Observation and Registry Study of Macular Telangiectasia Type 2: The MacTel Study

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: Sandheep Randhawa, M.D. (Royal Oak)

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

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

Coordinators: Kendra Mellert, MSA, CCRP; Royal Oak, MI 248-288-2280 Ext. 1313

Sylvia Puchrowicz-Ochocki; Royal Oak, MI 248-288-2280 Ext. 1315

Nicole Zielinski; Royal Oak, MI 248-288-2280 Ext. 1333

Debra Marcus, CCRP, COT; Grand Rapids, MI (616) 942-2406 Ext. 1720

Serena Neal, CCRP; Traverse City, MI (231) 938-0710 Ext.1516

Status:  Enrolling

Title: A Phase 1b open-label, single ascending dose clinical trial designed to evaluate the
safety of two dose levels of light-activated AU-011 for the treatment of subjects with small to
medium (2.0 mm – 3.4 mm thickness) primary choroidal melanoma.

Protocol Number: AU-011-101

Condition: Primary Choroidal Melanoma

The study will assess safety and preliminary efficacy of Light-activated AU-011:
– Low dose (20 μg) cohort – 3 patients
– High dose (40 μg) cohort – 3 patients

The study drug will be administered into the study eye by intravitreal injection followed 6 to 8 hours later by the laser treatment.

Sponsor: Aura Biosciences, Inc.

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

Coordinators: Sylvia Puchrowicz-Ochocki; Royal Oak, MI 248-288-2280 Ext. 1315

Status: Enrolling

Title: A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Filgotinib in Subjects with Active Non-Infectious Uveitis.

Protocol Number: GS-US-432-4097

Condition: Non-infectious Uveitis

Description: Eligible Subjects Will Be Randomly Assigned to One of the Following Treatment Groups:

– Filgotinib 200 mg administered once daily for up to 52 weeks
– Placebo to match administered once daily for up to 52 weeks

The study drug will be administered orally.

Sponsor: Gilead Sciences, Inc.

Principal Investigator: Lisa J. Faia, M.D.

Coordinator: Sylvia Ochocki; Royal Oak, MI 248-288-2280 Ext. 1315

Title:  A Two-Year, Randomized, Double-Masked, Multicenter, Three-Arm Study Comparing the Efficacy and Safety of RTH258 versus Aflibercept in Subjects with Neovascular Age-Related Macular Degeneration.

RTH258-C001

Neovascular Age-Related Macular Degeneration

Eligible subjects will be randomly assigned to 1 of 3 study arms.

Study arms include:

RTH258 (Dose A)

RTH258 (Dose B)

2 mg Aflibercept

Study drug will be administered into the study eye by intravitreal injection.

Alcon Research, Ltd.

Kean T. Oh, M.D.

Coordinator:  Serena Neal, CCRP Traverse City, MI 231-938-0710 Ext. 1516

Status:  In Follow-Up

Title:  A Phase II, Multicenter, Randomized, Single-Masked, Sham-Controlled Study of Safety, Tolerability and Evidence of Activity of Intravitreal APL-2 Therapy in Patients with Geographic Atrophy (GA).

Protocol Number:  POT-CP121614

Condition:  Geographic Atrophy

Description:  Eligible subjects will be randomly assigned to 1 of 4 study arms.

Study arms include:

APL-2 Monthly for 12 Months

APL-2 Every Other Month for 12 Months

Sham Monthly for 12 Months

Sham Every Other Month for 12 Months

Study drug/Sham will be administered into the study eye by intravitreal injection.

Sponsor:  Apellis Pharmaceuticals, Inc.

Principal Investigator:  Keen T. Oh, M.D.

Coordinator:  Serena Neal, CCRP; Traverse City, MI (231)938-0710 x 1516

Status:  In Follow-Up

Title:  A Phase II, Multicenter, Randomized, Single-Masked, Sham-Controlled Study of Safety, Tolerability and Evidence of Activity of Intravitreal APL-2 Therapy in Patients with Geographic Atrophy (GA).

Protocol Number:  POT-CP121614

Condition:  Geographic Atrophy

Description:  Eligible subjects will be randomly assigned to 1 of 4 study arms.

Study arms include:

APL-2 Monthly for 12 Months

APL-2 Every Other Month for 12 Months

Sham Monthly for 12 Months

Sham Every Other Month for 12 Months

Study drug/Sham will be administered into the study eye by intravitreal injection.

Sponsor:  Apellis Pharmaceuticals, Inc.

Principal Investigator:  Paul Raphaelian, M.D.

Coordinator:  Debra Markus, CCRP, COT; Grand Rapids, MI (616)942-2406 x 1720

Status:  In Follow-Up