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 Phase III Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution, 0.2% Twice Daily in Subjects With Neovascular Age-Related Macular Degeneration (AMD).

Protocol Number: Ohr-1601

Condition: Wet Age Related Macular Degeneration, Treatment Naïve

Description: Eligible subjects will be randomly assigned to one of the following treatment groups:

• Group A : Squalamine lactate ophthalmic solution, 0.2% twice daily (years 1 and 2) + ranibizumab (Lucentis) every four weeks (Year 1) and PRN ranibizumab ( as needed, Year 2)
• Group B: Placebo ophthalmic solution twice daily (Years 1 and 2) + monthly ranibizumab (Lucentis) every four weeks (year1) and PRN ranibizumab (Year 2) based on optical coherence tomography (OCT) guided re-treatment criteria
Sponsor: Ohr Pharmaceuticals

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

Coordinators:
Nicole Zielinski, Royal Oak, MI 248.288.9132 ext: 1333
Sylvia Puchrowicz-Ochocki, Royal Oak, MI 248.288.9132 ext: 1315

Status: In Follow-Up

Title: A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled
Study to assess the Efficacy and Safety of Lampalizumab Administered Intravitreally
to Patients with Geographic Atrophy Secondary to Age-related Macular Degeneration.

Protocol Number: GX29176

Condition: Dry Age-Related Macular Degeneration

The study will assess the efficacy and safety of lampalizumab:

– 10-mg lampalizumab administered by intravitreal injections every 4 weeks (Q4W)
– Sham injection administered by intravitreal injections every 4 weeks (Q4W)
– 10-mg lampalizumab administered by intravitreal injections every 6 weeks (Q6W)
– Sham injection administered by intravitreal injections every 6 weeks (Q6W)

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

Sponsor: F. Hoffman-La Roche, Ltd.

Principle Investigator: Alan J. Ruby, M.D.

Coordinators:
Sylvia Puchrowicz-Ochocki; Royal Oak, MI 248-288-2280 Ext. 1315
Nicole Zielinski; Royal Oak, MI 248-288-2280 Ext. 1333

Status: In Follow-Up

Title: A Phase I, Open-label, Multicenter Study Evaluating the Safety and Tolerability, Biologic Activity, Pharmacodynamics, and Pharmacokinetics of Single and Repeated Escalating Intravitreal Doses of ICON-1 in Patients with Uveal Melanoma Who are Planned to Undergo Enucleation .

Protocol Number: IT-003

Condition: Uveal Melanoma

Description: Eligible Subjects Will Be Assigned to One of the Three Cohorts that will be Enrolled Consecutively:

* Cohort 1: Single Dose of ICON-1

* Cohort 2: Two doses of ICON-1 one week apart

* Cohort 3: Two doses of ICON-1 one week apart

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

Sponsor: Iconic Therapeutics, Inc.

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

Coordinators:
Sylvia Puchrowicz-Ochocki; Royal Oak, MI 248-288-2280 Ext. 1315
Nicole Zielinski; Royal Oak, MI 248-288-2280 Ext. 1333

Status: Enrolling

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.

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

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