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: YOSEMITE: A Phase Ill, Multicenter, Randomized, Double-Masked, Active Comparator Controlled Study to Evaluate the Efficacy and Safety of R06867461 in Patients with Diabetic Macular Edema.)

Protocol Number: GR40349

Condition: Diabetic Macular Edema

Eligible subjects will be randomly assigned to one of three groups: Study arms include:
Arm A: RO6867461 injections monthly for at least 5 months, then injections every 8 weeks through week 96
Arm B: RO6867461 injections monthly for 3 months, then as needed dosing through week 96
Arm C: Aflibercept injections monthly for 4 months, followed by Aflibercept injections every 8 weeks to week 96.

Final visit for all arms: Week 100

Sponsor: F. Hoffmann-La Roche Ltd. Traverse City Site:

Principal Investigator: Kean Oh, MD

Coordinators: Julie Darling, RN, CCRP (231) 938-0170 X 1514
Serena Neal, CCRP (231) 938-0710 X 1516

Status: Enrolling

Title: RHINE: A Phase Ill, Multicenter, randomized, double-masked, active comparator-controlled study to evaluate the efficacy and safety of RO6867461 in patients with diabetic macular edema.)

Protocol Number: GR40398

Condition: Diabetic Macular Edema

Eligible subjects will be randomly assigned to one of three groups: Study arms include:
Arm A: RO6867461 injections monthly for at least 5 months, then injections every 8 weeks through week 96
Arm B: RO6867461 injections monthly for 3 months, then as needed dosing through week 96
Arm C: Aflibercept injections monthly for 4 months, followed by Aflibercept injections every 8 weeks to week 96

Final visit for all arms: Week 100

Sponsor: F. Hoffmann-La Roche Ltd.

Grand Rapids Site:
Principal Investigator: Alan Margherio, M.D.

Coordinator: Debra Markus, CCRP, COT (616) 942-2406 x 1720

Status: Enrolling

Title: DERBY: A Phase III, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy with Sham Injections in Patients with Geographic Atrophy (GA). Secondary to Age-Related Macular Degeneration (AMD)

Protocol Number: APL2-303

Condition:  Geographic Atrophy Secondary to Age-Related Macular Degeneration

Eligible subjects will be randomly assigned to one of four groups.

Study arms include:

APL-2 15 mg/0.1mL Monthly Injections

APL-2 15 mg/0.1mL Every-Other-Month Injections

Sham Monthly Injections

Sham Every-Other-Month Injections

Sponsor: Apellis Pharmaceuticals

Principle Investigator:  Kean T. Oh, M.D. (Traverse City)

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

Coordinators: Julie Darling, RN, CCRP; Traverse City, MI (231) 938-0710 Ext. 1514

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

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

Status:  Enrolling

Title: OAKS: A Phase III, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy with Sham Injections in Patients with Geographic Atrophy (GA). Secondary to Age-Related Macular Degeneration (AMD)

Protocol Number: APL2-304

Condition: Geographic Atrophy Secondary to Age-Related Macular Degeneration

Eligible subjects will be randomly assigned to one of four groups.

Study arms include:

APL-2 15 mg/0.1mL Monthly Injections for 24 months

APL-2 15 mg/0.1mL Every-Other-Month Injections for 24 months

Sham Monthly Injections for 24 months

Sham Every-Other-Month Injections for 24 months

Sponsor: Apellis Pharmaceuticals

Principal Investigator:  Paul V. Raphaelian, M.D.

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

Status:  Enrolling

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: Sandeep 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

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

Julie Darling, RN, CCRP; Traverse City, MI (231) 938-0710 Ext. 1514

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.

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

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

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:  Kean 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