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.
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.
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.
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.
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
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.
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.
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.
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.
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)
Status: Enrolling
Protocol Number: OTX-TKI-2023-AMD-303
Condition: Treatment Naïve Neovascular Age-Related Macular Degeneration or Neovascular Age-Related Macular Regeneration Diagnosed within 4 months prior to screening.
Participant Group/Arm Intervention/Treatment Experimental: OTX-TKI Re-dose
Drug: OTX-TKI • Intravitreal Injection of OTX-TKI
Active Comparator: Aflibercept 2mg on label
Drug: Aflibercept • Intravitreal Injection of 2mg of aflibercept
Other: Aflibercept 8mg high dose
Drug: Aflibercept • Intravitreal Injection of 8mg of aflibercept
Sponsor: Ocular Therapeutix, Inc.
Royal Oak Site:
Principal Investigator: Lisa J. Faia, M.D
