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: PAVILION: A Phase III, Multicenter, Randomized Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Patients with Diabetic Retinopathy.
Protocol Number: GR41675
Condition: Non-Proliferative Diabetic Retinopathy without Center-Involved Diabetic Macular Edema
Eligible Subjects will be randomly assigned into one of the two study arms:
PDS Arm: Participants randomized to the PDS arm will receive two intravitreal ranibizumab injection every 4 weeks (loading phase) and will then have the PDS implant (pre-filled with ranibizumab) surgically inserted. PDS implant refills will be administered at fixed 36-week intervals.
Comparator Arm: Participants randomized to the comparator arm will undergo study visits every 4 weeks for observation and comprehensive clinic monitoring for the first 60 weeks. After 60 weeks, participants will receive two intravitreal ranibizumab injection every 4 weeks (loading phase) and will then have the PDS implant (pre-filled with ranibizumab). PDS implant refills will be administered at fixed 36-week intervals.
The duration of study participation will depend o health authority approval of the PDS implant for diabetic retinopathy without center-involved diabetic macular edema.
Sponsor: F. Hoffman – La Roche Ltd
Additional information about this trial is available at http://www.ClinicalTrials.gov
Royal Oak Site:
Principal Investigator: Jeremy D. Wolfe, M.D.
Coordinators: Neil Shah, MPH 248-288-9132 ext. 1315
Opal Potter, MS 248-288-9132 ext. 1333
Kendra Mellert, MSA, CCRC 248-288-9132 ext. 1313
Title: A Phase 2 Trial Of AU-011 Via Suprachoroidal Administration With A Dose Escalation Phase (Open-Label, Ascending Single And Repeat Dose) And A Randomized, Masked Dose Expansion Phase Designed To Evaluate The Safety And Efficacy Of AU-011 In Subjects With Primary Indeterminate Lesions And Small Choroidal Melanoma.
Protocol Number: AU-011-202
Condition: Primary Indeterminate Lesions and Small Choroidal Melanoma
Eligible Subjects will be assigned into one of six study cohorts:
Cohort 1: AU-011 dose of 20μg delivered via suprachoroidal injection followed by a laser application 4-6 hours after the suprachoroidal injection. AU-011 dose may be reduced to 10μg.
Cohort 2: AU-011 dose of 40μg delivered via suprachoroidal injection followed by a laser application 4-6 hours after the suprachoroidal injection.
Cohort 3: AU-011 dose of 40μg delivered via suprachoroidal injection followed by two laser applications about 30 minutes apart, with the first laser application 4-6 hours after the suprachoroidal injection.
Cohort 4: AU-011 maximum tolerated dose of either 10μg, 20μg or 40μg delivered via suprachoroidal injection for 2 weeks each followed by one laser application 4-6 hours after the suprachoroidal injection or two laser applications about 30 minutes apart, with the first laser application 4-6 hours after the suprachoroidal injection.
Cohort 5: AU-011 maximum tolerated dose of either 10μg, 20μg or 40μg delivered via suprachoroidal injection for 3 weeks each followed by one laser application 4-6 hours after the suprachoroidal injection or two laser applications about 30 minutes apart, with the first laser application 4-6 hours after the suprachoroidal injection.
Cohort 6: Randomized AU-011 or sham study drug in a 1:1 ratio. If 2 cycles of study drug are given, the second cycle of AU-011 or sham will be administered at Week 6 or after resolution of intraocular inflammation following the first cycle.
Final Visit for all arms: Week 104
Sponsor: Aura Biosciences, Inc.
Additional information about this trial is available at http://www.ClinicalTrials.gov – NCT: 04417530
Royal Oak Site:
Principal Investigator: Antonio Capone Jr., M.D.
Coordinators: Kendra Mellert, MSA, CCRC 248-288-9132 ext. 1313
Neil Shah, MPH 248-288-9132 ext. 1315
20200484
#26907840.0
IRB Conditions
Satisfied at the Protocol
Level
Apr 01, 2020
Title: Prospective Randomized Comparative Trial for Combination Dexamethasone Implant with PRN Anti-VEGF Therapy to Anti-VEGF Therapy Alone In Treatment Resistant Diabetic Macular Edema: Informing The Role For Imaging Biomarkers and Combination Therapy.
Protocol Number: PRECISION Study
Condition: Diabetic Macular Edema
Eligible subjects will be randomly assigned to one of two groups:
Study groups include:
Group A: One aflibercept injection prior to randomization. Dexamethasone implant injection given at month 0 and then as needed if 10 weeks or more since last dexamethasone implant injection. If less than 10 weeks since last dexamethasone implant injection, then aflibercept injection as needed if edema persists.
Group B: One aflibercept injection prior to randomization. Aflibercept injection given at month 0 and then as needed aflibercept injection given at months 1 through 6 for persistent Diabetic Macular Edema.
Final visit for all arms: Month 6
Sponsor: Cleveland Clinic
Allergan
#26141468.0
IRB Approved at the Study Level Dec 15, 2019
Title: The GUARD Trial: A Multicenter, Randomized, Controlled, Prospective, Adaptive Phase 3 Clinical Trial of Repeated Intravitreal Injections of ADX-2191 Versus Standard-Of-Care for the Prevention of Proliferative Vitreoretinopathy.
Protocol Number: ADX-2191-PVR-001
Sponsor: Aldeyra Therapeutics, Inc.
Study Population: Recurrent Retinal Detachment with Proliferative Vitreoretinopathy (PVR); or Open Globe Trauma with Retinal Detachment
Study Treatments:
Eligible Subjects will be randomly assigned into either one of the two study arms:
• Control Arm: Standard Procedures (Pars Plana Vitrectomy—surgery for attachment of retina)
• Intervention Arm: Standard Procedures with the addition of repeated intravitreal injections of ADX-2191 until post-operative Week 16
Final Visit for all arms: Week 24
Royal Oak Site:
Principal Investigator: Tamer H. Mahmoud, M.D., Ph.D.
Coordinators:
Jennifer Parsons 248-288-9132 ext. 1333
Neil Shah, MPH 248-288-9132 ext. 1315
Kendra Mellert, MSA CCRC 248-288-9132 ext. 1313
Title: ISIS 696844-CS5: A Phase 2, Randomized, Placebo-Controlled, Double-Masked Study to Assess Safety and Efficacy of Multiple Doses of IONIS-FB-LRX, an Antisense Inhibitor of Complement Factor B, in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD).
Protocol Number: ISIS 696844-CS5
Condition: Geographic Atrophy Secondary to Age-Related Macular Degeneration
Eligible subjects will be randomly assigned to one of four possible dose levels in 2 stages.
Stage 1: 60 Subjects, approximately 15 Subjects receiving placebo
Dose Level 1: Subcutaneous Injections of IONIS-FB-LRX vs Placebo every 2 weeks for the first 5 weeks then every 4 weeks for a total of 45 weeks
Dose Level 2: Subcutaneous Injections of IONIS-FB-LRX vs Placebo every 2 weeks for the first 5 weeks then every 4 weeks for a total of 45 weeks
Dose Level 3: Subcutaneous Injections of IONIS-FB-LRX vs Placebo every 2 weeks for the first 5 weeks then every 4 weeks for a total of 45 weeks
Stage 2: 270 Subjects. 90 Subjects receiving placebo
Dose Level 1: Subcutaneous Injections of IONIS-FB-LRX vs Placebo every 2 weeks for the first 5 weeks then every 4 weeks for a total of 45 weeks
Dose Level 2: Subcutaneous Injections of IONIS-FB-LRX vs Placebo every 2 weeks for the first 5 weeks then every 4 weeks for a total of 45 weeks
Length of Study: 57 Weeks
Sponsor: Ionis Pharmaceuticals, Inc.
Royal Oak Site:
Principal Investigator: Antonio Capone Jr., M.D.
Coordinators:
Neil Shah, MPH, CRC 248-288-9132 ext. 1315
Kendra Mellert, MSA CCRC 248-288-9132 ext. 1313
Approved by Sterling IRB
IRB ID: 7293-ACapone
Title: A Registry Of Patients With Primary Choroidal Melanoma (CM) Or Indeterminate Lesions (ILS).
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.
Coordinators:
Kendra Mellert, MSA CCRC 248-288-9132 ext. 1313
Neil Shah, MPH 248-288-9132 ext. 1315
Jennifer Parsons 248-288-9132 ext. 1333
Title: PANDA2: A Phase 3, Multicenter, Double-Masked, Randomized, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Conbercept Intravitreal Injection in Subjects with Neovascular Age-Related Macular Degeneration.
Protocol Number: KHB-1802
Condition: Neovascular Age-Related Macular Degeneration, Treatment Naive.
Eligible subjects will be randomly assigned to one of three study arms.
Study arms include:
Conbercept 0.5 mg Intravitreal Injections
Conbercept 1.0 mg lntravitreal Injections
Aflibercept 2.0 mg Intravitreai Injections
Sponsor: Chengdu Kanghong Biotechnology Co., Ltd.
Traverse City Site:
Principal Investigator: Douglas Covert, M.D., MPH
Coordinators: Julie Darling, RN, CCRP (231) 938-0710 Ext. 1514
Serena Neal, CCRP (231) 938-0710 Ext.1516
Title: LUMINA: A Phase III, Multicenter, Sham-Controlled, Randomized, Double-Masked Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 µg DE-109 for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye.
Protocol Number: 010906IN
Condition: Non-Infectious Uveitis
ClinicalTrials.gov Identifier: NCT03711929
Eligible subjects will be randomly assigned to one of three groups:
Study arms include:
Arm A: DE-109 injections every 2 months (Day 1, Month 2, and Month 4)
Arm B: Sham procedure every 2 months (Day 1, Month 2, and Month 4)
Arm C: DE-109 injections at a blinded dose every 2 months (Day 1, Month 2, and Month 4)
Final visit for all arms: Month 12
Sponsor: Santen Incorporated
Royal Oak Site:
Principal Investigator: Lisa J. Faia, M.D.
Coordinators: Neil Shah (248) 288-9132 x 1315
Kendra Mellert (248) 288-9132 x 1313
Status: Enrolling
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