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 Three-Part, Phase I Study to Investigate the Safety, Tolerability,
Pharmacokinetics, and Efficacy of Zifibancimig Following Intravitreal Administration of
Multiple Ascending Doses and Continuous Delivery From the Port Delivery in Patients
with Neovascular Age-Related Macular Degeneration (BURGUNDY).
Protocol Number: BP41670
Condition: Neovascular Age-Related Macular Degeneration (nAMD)
Eligible Subjects will be randomly assigned into one of the three study arms in Part 3:
Part 3
Depending on the participants’ treatment history, participants may receive up to 2 IVT
anti-VEGF or anti-VEGF/Ang-2 administrations during a run-in period before screening
of Either ranibizumab, aflibercept, or faricimab. After randomization (occurring within 24
hours of implant insertion on Day 1), participants will have the implant (filled with
approximately 20 μL of either zifibancimig or 100 mg/mL of ranibizumab) surgically
inserted in the study eye. The dose levels of zifibancimig in the PD implant will be 40
mg/mL or 80 mg/mL. Participants randomized to the “PD with zifibancimig” arms may
receive implant refill-exchanges with their assigned dose of zifibancimig from Week 48
onward if the pre-specified disease activity criteria are met. Participants randomized to
the “PD with ranibizumab” arm will receive implant refill-exchanges with ranibizumab
every 24 weeks. At each refill-exchange, a volume of approximately 100 μL of drug
(zifibancimig or ranibizumab) will be injected into the implant. The volume of newly
introduced drug remaining in the implant after the refill-exchange procedure will be
approximately 20 μL.
Final Visit for Part 3: The duration of Part 3 is up to 154 weeks including a run-in period
of up to 8 weeks (if required depending on the participant’s prior IVT anti-VEGF or anti-
VEGF/Ang-2 history), a screening period of up to 10 days, and a treatment and follow-
up period of 144 weeks.
Sponsor: F. Hoffman-La Roche Ltd
Royal Oak Site:
Principal Investigator: Jeremy D. Wolfe, M.D.
Coordinators:
Emily Manasian, BS 248-288-9132 ext. 1334
Ryan Stickney, BS 248-288-9132 ext. 1333
Title: A Phase 2, Multicenter, Randomized, Double-Masked Parallel-Group Study to
Assess the Efficacy and Safety of KHK4951, a Vascular Endothelial Growth Factor
Receptor Inhibitor, in Patients with Neovascular Age-Related Macular Degeneration.
Protocol Number: 4951-002
Condition: Neovascular Age-Related Macular Degeneration
Eligible Subjects will be randomly assigned into one of the three study arms:
Arm A: Run-in period intravitreal injection Aflibercept 2 mg every 4 weeks for a
total of 3 IVT injections at Day 1, Day 29 and Day 57. 44 week treatment period of
KHK4951 eye drop 0.5 w/v% daily. Rescue treatment with intravitreal injection
Aflibercept 2 mg may be administered after Day 1 before week 52 if criteria are met.
Arm B: Run-in period intravitreal injection Aflibercept 2 mg every 4 weeks for a
total of 3 IVT injections at Day 1, Day 29 and Day 57. 44 week treatment period of
KHK4951 eye drop 2.0 w/v% daily. Rescue treatment with intravitreal injection
Aflibercept 2 mg may be administered after Day 1 before week 52 if criteria are met.
Control Arm: Run-in period intravitreal injection Aflibercept 2 mg every 4 weeks
for a total of 3 IVT injections at Day 1, Day 29 and Day 57. 44 week treatment period of
KHK4951 eye drop 2.0 w/v% twice daily. Rescue treatment with intravitreal injection
Aflibercept 2 mg may be administered after Day 1 before week 52 if criteria are met.
Final Visit for all Arms A, B and C: Week 56
Sponsor: Kyowa Kirin Co., Ltd.
Royal Oak Site:
Principal Investigator: Antonio Capone Jr., M.D.
Coordinators:
Ryan Stickney, BS 248-288-9132 ext. 1333
Title: A Phase 3, Multicenter, Double-Masked, Randomized, Parallel-Group Study to
Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (axitinib implant) in Subjects
with Neovascular Age-Related Macular Degeneration.
Protocol Number: OTX-TKI-2023-AMD-301
Condition: Treatment Naïve Neovascular Age-Related Macular Degeneration
Eligible Subjects will be randomly assigned into one of two study groups:
OTX-TKI Treatment Group: 1 injection of 2 mg (0.05 mL aflibercept at 8 weeks
and 4 weeks prior to first investigational agent injection. One injection of OTX-TKI
(axitinib implant) 0.45 mg for intravitreal injection at Randomization.
Control Group: 1 injection of 2 mg (0.05 mL aflibercept at 8 weeks and 4 weeks
prior to first investigational agent injection. One intravitreal injection of aflibercept 2 mg
(0.05mL) at Randomization.
Sponsor: Ocular Therapeutix, Inc.
Royal Oak Site:
Principal Investigator: Kimberly A. Drenser, M.D., Ph.D.
Coordinators:
Dawn Gedvilas 248-288-9132 ext. 1334
Natalia Gomez 248-288-9132 ext. 1315
Title: A Long-term Follow-Up Study to Evaluate the Safety and Efficacy of RGX-314
Following Subretinal Administration in Participants with Neovascular Age-related
Macular Degeneration and Fellow Eye Treatment Substudy.
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.
Coordinators:
Dawn Gedvilas 248-288-9132 ext. 1334
Natalia Gomez 248-288-9132 ext. 1315
Title: A Phase 2, Double-masked, Randomized, Sham-controlled, Multiple-dose Study of the Efficacy and Safety of Intravitreal KUS121 in the Treatment of Non-Arteritic Central Retinal Artery Occlusion (CRAO) –GION-.
Protocol Number: KDK-1101-02
Condition: Non-Arteritic Central Retinal Artery Occlusion (CRAO)
Eligible Subjects will be randomly assigned into one of the three study arms:
Arm A: An intravitreal injection of KUS121 25 μg/eye for 3 consecutive days starting at Day 1 Screening.
Arm B: An intravitreal injection of KUS121 50 μg/eye for 3 consecutive days starting at Day 1 Screening.
Control Arm: A sham treatment 0 μg/eye for 3 consecutive days starting at Day 1 Screening.
Final Visit for all Arms A, B and Control: Week 48
Sponsor: Kyoto Drug Discovery & Development Co., Ltd.
Royal Oak Site:
Principal Investigator: Jeremy D. Wolfe, M.D.
Coordinators:
Ryan Stickney, BS 248-288-9132 ext. 1333
Emily Manasian, BS 248-288-9132 ext. 1334
Title: A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of
Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects
with Primary Indeterminate Lesions or Small Choroidal Melanoma.
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
Coordinators:
Elise Kowalski, BS 248-288-9132 Ext.1370
Emily Manasian, BS 248-288-9132 Ext. 1334
Stephanie Smith, BS 248-288-9132 Ext. 1315
Title: BELVEDERE: A Phase IIIb/IV, Multicenter, Open-Label, Single-Arm Study of the
Efficacy and Safety of the Port Delivery System With Ranibizumab in Patients with
Neovascular Age-Related Macular Degeneration Previously Treated With Intravitreal Agents
Other Than Ranibizumab.
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.
Coordinators:
Christopher Tripp, BS 248-288-9132 ext. 1315
Opal Potter, MS 248-288-9132 ext. 1333
Title: A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants with nAMD (ASCENT).
Protocol Number: RGX-314-3101
Condition: Neovascular Age-Related Macular Degeneration (nAMD)
Eligible Subjects will be randomly assigned into one of the three study arms:
RGX-314 Treatment Arm A: Screening/Active run-in period of up to 6 weeks. An intravitreal injection of ranibizumab (Lucentis®) 0.5 mg at the first visit, followed by an intravitreal injection of aflibercept (Eylea®) 2 mg approximately 4 weeks later. Surgical visit on Day 1 to receive a subretinal dose of RGX-314 200 μL (6.4 X 1010 GC) in the study eye. Postoperative safety visits on Day 2 and Day 8. Additional dose of aflibercept (Eylea) 2 mg to be given 2 weeks after surgery. Subjects will return for site visits at specified intervals for approximately 1 year. Additional doses of intravitreal ranibizumab may be given if recommended by the study doctor.
RGX-314 Treatment Arm B: Screening/Active run-in period of up to 6 weeks. An intravitreal injection of ranibizumab (Lucentis®) 0.5 mg at the first visit, followed by an intravitreal injection of aflibercept (Eylea®) 2 mg approximately 4 weeks later. Surgical visit on Day 1 to receive a subretinal dose of RGX-314 200 μL (1.3 X 1011 GC) in the study eye. Postoperative safety visits on Day 2 and Day 8. Additional dose of aflibercept (Eylea) 2 mg to be given 2 weeks after surgery. Subjects will return for site visits at specified intervals for approximately 1 year. Additional doses of intravitreal ranibizumab may be given if recommended by the study doctor.
Control Arm: Screening/Active run-in period of up to 6 weeks. An intravitreal injection of ranibizumab (Lucentis®) 0.5 mg at the first visit, followed by an intravitreal injection of aflibercept (Eylea®) 2 mg approximately 4 weeks later. Subjects will return at Week 2 and will receive intravitreal aflibercept (Eylea®) 2 mg. Following Week 2, subjects will return for monthly study visits and to receive an intravitreal injection of aflibercept (Eylea®) 2 mg. Visits will continue for approximately one year. After one year, eligible subjects will be offered the choice to receive a subretinal dose of RGX-314.
Final Visit for all Arms A and B: Week 54
Final Visit for Control Arm: Week 54. Subjects opting to receive RGX-314 at Week 54 will then be followed until Week 90.
Sponsor: REGENXBIO, Inc.
Royal Oak Site:
Principal Investigator: Jeremy D. Wolfe, M.D.
Coordinators:
Christopher Tripp, BS 248-288-9132 ext. 1315
Ali Fanharawi, MD 248-288-9132 ext. 1333
Title: A Randomized, Partially Masked, Controlled, Phase 2b/3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants with nAMD (ATMOSPHERE).
Protocol Number: RGX-314-2104
Condition: Neovascular Age-Related Macular Degeneration (nAMD)
Eligible Subjects will be randomly assigned into one of the three study arms:
RGX-314 Treatment Arm A: Screening/Active run-in period of up to 6 weeks. An intravitreal injections of ranibizumab (Lucentis®) 0.5 mg at the first visit, followed by a second 6 weeks later. Surgical visit on Day 1 to receive a subretinal dose of RGX-314 200 μL (6.4 X 1010 GC) in the study eye. Postoperative safety visits on Day 2 and Day 8. Subjects will return for monthly site visits for approximately 2 years. Additional doses of intravitreal ranibizumab may be given if recommended by the study doctor.
RGX-314 Treatment Arm B: Screening/Active run-in period of up to 6 weeks. An intravitreal injections of ranibizumab (Lucentis®) 0.5 mg at the first visit, followed by a second 6 weeks later. Surgical visit on Day 1 to receive a subretinal dose of RGX-314 200 μL (1.3 X 1011 GC) in the study eye. Postoperative safety visits on Day 2 and Day 8. Subjects will return for monthly site visits for approximately 2 years. Additional doses of intravitreal ranibizumab may be given if recommended by the study doctor.
Control Arm: Screening/Active run-in period of up to 6 weeks. An intravitreal injections of ranibizumab (Lucentis®) 0.5 mg at the first visit, followed by a second 6 weeks later. Subjects will return at Week 2 and will receive intravitreal ranibizumab 0.5 mg. Following Week 2, subjects will return for monthly study visits and to receive an intravitreal injection of ranibizumab 0.5 mg. Visits will continue for approximately one year. After one year, eligible subjects will be offered the choice to receive a subretinal dose of RGX-314.
Final Visit for all Arms A and B: Week 98
Final Visit for Control Arm: Week 54. Subjects opting to receive RGX-314 at Week 54 will then be followed until Week 98.
Sponsor: REGENXBIO, Inc.
Royal Oak Site:
Principal Investigator: Tamer H. Mahmoud, M.D., Ph.D.
Coordinators:
Christopher Tripp, BS 248-288-9132 ext. 1315
Opal Potter, MS 248-288-9132 ext. 1333
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
Christopher Tripp, BS 248-288-9132 ext. 1315
Opal Potter, MS 248-288-9132 ext. 1333
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