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: Patients’ Quality Of Life Following Vitrectomy With Gas Tamponade: A Research Survey.
Protocol Number: PYK-QL001
Condition: Vitrectomy With Gas Tamponade
Eligible Subjects will complete a quality of life questionnaire (EQ-5D-5L) at the following clinic visits after vitrectomy surgery with gas
tamponade – visit 1/post-operation Day 1, visit 2/post operation Week 1 and visit 3/post-operation Month 1. We will also collect general
information about your surgery and recovery period from your medical record.
Final Visit for all arms: Visit 3/Post-operation Month 1
Sponsor: Pykus Therapeutics, Inc.
Royal Oak Site:
Principal Investigator: Tamer H. Mahmoud, M.D., Ph.D.
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: 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: A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study
To Investigate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of
RO7200220 Administered Intravitreally In Patients With Uveitic Macular Edema
[SANDCAT]
Protocol Number: GR44278
Condition: Non-Infectious Posterior Uveitis Macular Edema
Eligible Subjects will be randomly assigned into one of three treatment arms:
Arm A: Participants randomized to Arm A will receive four RO7200220 1.0 mg IVT
injections Q4W from Day 1 to Week 12, followed by PRN dosing from Week 20 to Week
48. No study treatment will be administered at the Week 16 and Week 52 visits.
Arm B: Participants randomized to Arm B will receive four RO7200220 0.25 mg IVT
injections Q4W from Day 1 to Week 12, followed by PRN dosing from Week 20 to Week
48. No study treatment will be administered at the Week 16 and Week 52 visits.
Arm C: Participants randomized to Arm C will receive four sham injections Q4W from
Day 1 to Week 12, followed by PRN sham dosing from Week 20 to Week 48. No study
treatment will be administered at the Week 16 and Week 52 visits.
Final Visit for all arms: Week 52
Sponsor: F. Hoffman – La Roche Ltd.
Royal Oak Site:
Principal Investigator: Lisa J. Faia, MD
Coordinators:
Courtney Gifford 248-288-9132 Ext. 1333
Elise Kowalski, MS 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 Phase 2b, Randomized, Double-masked, Multicenter, Dose-ranging, Sham-
controlled Clinical Trial to Evaluate Intravitreal JNJ-81201887 (investigational gene
therapy) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA)
Secondary to Age-related Macular Degeneration (AMD).
Protocol Number: 81201887MDG2001
Condition: To be eligible, subjects must be diagnosed with Geographic Atrophy (GA)
Secondary to Age-Related Macular Degeneration. A complete list of inclusion and
exclusion criteria is available for review with a study doctor.
Purpose: To determine if the investigational product, JNJ-81201887 is superior to sham (
i.e. no treatment) in reducing the geographic atrophy (GA) age-related macular
degeneration lesion growth in the study eye.
Eligibility: Information about inclusion and exclusion criteria can be found at
clinicaltrials.gov.
Eligible Subjects will be randomly assigned into one of three study arms to receive
either a single intravitreal injection of investigational product or sham procedure.:
Arm A – A single intravitreal injection of investigational product low dose 8.2 X 1011
vg/mL; 8.2 x 1010 vg/0.1mL with a 20-day oral prednisone course staring on Day 1 and a
single periocular corticosteroid injection on Day 4 for prophylaxis of intraocular inflammation.
Arm B – A single intravitreal injection of investigational product high dose 4.1 X 1012
vg/mL; 4.1 x 1011 vg/0.1mL with a 20-day oral prednisone course staring on Day 1 and
a single periocular corticosteroid injection on Day 4 for prophylaxis of intraocular
inflammation.
Arm C – A single matching placebo and sham periocular injection with a 20-day oral
prednisone course staring on Day 1 and a single periocular corticosteroid injection on
Day 4 for prophylaxis of intraocular inflammation.
Final Visit for all arms: Month 18
Sponsor: Janssen Research & Development
Principal Investigator: Lisa J. Faia, MD
Coordinators:
Emily Manasian, BS 248-288-9132 Ext. 1334
Stephanie Smith, BS 248-288-9132 Ext. 1315
Title: A Randomized, Double-Masked, Placebo-Controlled, Parallel-Arm Study to
Evaluate the Efficacy and Safety of RZ402 in Participants with Diabetic Macular Edema
(DME).
Protocol Number: RZ402-201
Condition: Diabetic Macular Edema
Eligible Subjects will be randomly assigned into one of four study groups to receive
either RZ402 or placebo tablets.:
Group 1 – One 50 mg RZ402 tablet and two 200 mg placebo tablets for a total of three
tablets each day from Day 1 through Day 85 / Week 12 (End of Treatment). The target
dose of RZ402 is 50 mg.
Group 2 – One 50 mg placebo tablet, one 200 mg
RZ402 tablet and one 200 mg placebo tablet for a total of three tablets each day from Day 1 through Day 85 / Week 12
(End of Treatment). The target dose of RZ402 is 200 mg.
Group 3 – One 50 mg placebo tablet and two 200 mg RZ402 tablets for a total of three
tablets each day from Day 1 through Day 85 / Week 12 (End of Treatment). The target
dose of RZ402 is 400 mg.
Group 4 – One 50 mg placebo tablet and two 200 mg placebo tablets for a total of three
tablets each day from Day 1 through Day 85 / Week 12 (End of Treatment). The target
dose of RZ402 is 0 mg.
Final Visit for all arms: Day 113 / Week 16
Sponsor: Rezolute, Inc.
Royal Oak Site:
Principal Investigator: Lisa J. Faia, MD
Coordinators:
Courtney Gifford 248-288-9132 Ext. 1333
Elise Kowalski, MS 248-288-9132 Ext.1370
Emily Manasian, BS 248-288-9132 Ext. 1334
Stephanie Smith, BS 248-288-9132 Ext. 1315
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