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 3 multicenter, Randomized, Double-Masked, Sham-Controlled Clinical Trial to Assess the Safety and Efficacy of Intravitreal Administration of Zimura™ (Complement C5 Inhibitor) in Patients with Geographic Atrophy Secondary to Age- Related Macular Degeneration.

Protocol Number: ISEE2008 GATHER2

Condition: Geographic Atrophy Secondary to Age-Related Macular Degeneration

Eligible Subjects will be randomly assigned into one of the two study arms:

Zimura Arm: Zimura 2 mg intravitreal injections at day 1 followed by continued dosing monthly through Month 12. Subjects will be re-randomized at Month 12 to receive either Zimura 2 mg administered monthly from Month 12 through Month 23 OR sham administered at Months 12, 14, 16, 18, 20, and 22, and Zimura 2 mg administered every other month at Months 13, 15, 17, 19, 21, and 23.

Sham Arm: Sham injections at day 1 followed by continued dosing monthly through Month 23.

Final Visit for all arms: Month 24

Sponsor: Iveric bio, Inc.

Royal Oak Site:

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

Coordinators:

Christopher Tripp, BS    248-288-9132 ext. 1315

Opal Potter, MS   248-288-9132 ext. 1333

Title: PAGODA: A Phase III, Multicenter, Randomized, Visual Assessor-Masked, Active-Comparator Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Patients with Diabetic Macular Edema.

Protocol Number: GR40550

Condition: 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 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 24-week intervals.

Intravitreal Arm: Participants randomized to the intravitreal arm will receive intravitreal ranibizumab injection every 4 weeks until they receive the PDS implant (pre- filled with ranibizumab). PDS implant refills will be administered at fixed 24-week intervals.

Study expected to be completed in December 2022.

Sponsor: F. Hoffman – La Roche Ltd

Royal Oak Site:

Principal Investigator: Jeremy D. Wolfe, M.D.

Coordinators:

Neil Shah, MPH 248-288-9132 ext. 1315

Kendra Mellert, MSA, CCRC 248-288-9132 ext. 1313

 

Title: COMINO: A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients with Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion.

Protocol Number: GR41986

Condition: Central Retinal or Hemiretinal Vein Occlusion

Eligible Subjects will be randomly assigned into one of the two study arms in part 1 and part 2.:

Part 1

Arm A: Faricimab 6 mg injections monthly for 5 months (through week 20) for a total of 6 injections.

Arm B: Aflibercept 2 mg injections monthly for 5 months (through week 20) for a total of 6 injections.

Part 2

Arm A and Arm B: Faricimab 6 mg injections administered according to a personalized treatment interval dosing regimen either every 4 weeks or every 16 weeks to receive between 3 and 12 injections from week 24 through week 68. At faricimab dosing intervals, treatment intervals will be maintained or adjusted (increased by 4 weeks or decreased by 4, 8 or 12 weeks) based on retinal thickness and reading test results. Sham procedures (empty vial and an empty syringe without a needle) will be administered during study visits as which no faricimab treatment is administered to preserve the study masking.

Final Visit for all arms: Week 72 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:   Opal Potter, MS   248-288-9132 ext. 1333

Neil Shah, MPH   248-288-9132 ext. 1315

Kendra Mellert, MSA, CCRP  248-288-9132 ext. 1313

 

Title: GALLEGO: A Phase II, Multicenter, Randomized, Single-Masked, Sham-Controlled Study to Assess Safety, Tolerability, And Efficacy Of Intravitreal Injections Of RO7171009 In Patients With Geographic Atrophy Secondary To Age-Related Macular Degeneration.

Protocol Number: GR40973

Condition: Geographic Atrophy Secondary To Age-Related Macular Degeneration

Eligible Subjects will be randomly assigned into one of the four study arms:

Arm A: RO7171009 every 4 weeks for 68 weeks

Arm B: Simulated Injections every 4 weeks for 68 weeks

Arm C: RO7171009 every 8 weeks for 64 weeks

Arm D: Simulated Injections every 8 weeks for 64 weeks

Final Visit for all arms: Week 76

Sponsor: Genentech, Inc.

Royal Oak Site:

Principal Investigator: Jeremy D. Wolfe, M.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: A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared with Intravitreal Aflibercept in Participants with Visual Impairment Due to Treatment-naïve Macular Edema Secondary to Retinal Vein Occlusion (RVO) (BEACON).

Protocol Number: KS301P103

Condition: Macular Edema Secondary to Retinal Vein Occlusion (RVO)

Eligible Subjects will be randomly assigned into one of the two study arms:

Arm A: KSI-301 5 mg intravitreal injections once every 8 weeks after two monthly doses from Day 1 to Week 20 followed by an individual dosing regimen from Week 24 to Week 44 determined based on response to treatment.

Arm B: Aflibercept 2 mg intravitreal injections once every 4 weeks from Day 1 to Week 20 followed by an individual dosing regimen from Week 24 to Week 44 determined based on response to treatment.

Participants are followed every 4 weeks and get sham when KSI-301 or aflibercept is not indicated.

Final In-person Visit for all arms: Week 48

Follow-up Phone Call for all arms: Week 52

Sponsor: Kodiak Sciences Inc.

Royal Oak Site:

Principal Investigator: Jeremy D. Wolfe, M.D.

Coordinators:

Opal Potter, MS 248-288-9132 ext. 1333

Christopher Tripp, BS 248-288-9132 ext. 1315

 

Title: A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared with Intravitreal Aflibercept in Participants with Visual Impairment Secondary to Treatment-naïve Diabetic Macular Edema (DME) (GLIMMER).

Protocol Number: KS301P105

Condition: Treatment-naïve Diabetic Macular Edema (DME)

Eligible Subjects will be randomly assigned into one of the two study arms:

KSI-301 Arm: KSI-301 5 mg intravitreal injections for 3 monthly loading doses, followed by individualized dosing between every-8 to every-24 weeks based on disease activity.

Aflibercept Arm: aflibercept 2 mg intravitreal injections for 5 monthly loading doses, followed by every 8 week dosing.

Participants are followed every 4 weeks and get sham when KSI-301 or aflibercept is not indicated

Final In-person Visit for all arms: Week 104

Follow-up Phone Call for all arms: Week 108

Sponsor: Kodiak Sciences Inc.

Royal Oak Site:

Principal Investigator: Jeremy D. Wolfe, M.D.

Coordinators:

Opal Potter, MS 248-288-9132 ext. 1333

Christopher Tripp, BS 248-288-9132 ext. 1315

 

Title: PHOTON: A Randomized, Double-Masked, Active-Controlled Phase 2/3 Study Of The Efficacy and Safety Of High-Dose Aflibercept In Patients With Diabetic Macular Edema.

Protocol Number: VGFTe(HD)-DME-1934

Sponsor: Regeneron Pharmaceuticals, Inc.

Study Population: Diabetic Macular Edema

Study Treatments:

Eligible Subjects will be randomly assigned into either one of the three study arms:

Arm A: Aflibercept 2 mg every 8 weeks after 5 initial monthly injections

Arm B: High dose Aflibercept every 16 weeks after 3 initial monthly injections

Arm C: High dose Aflibercept every 12 weeks after 3 initial monthly injections

 

Final Visit for all arms: Week 96

 

Additional information about this trial is available at Clinicaltrial.gov

 

Royal Oak Site:

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

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 2: AU-011 dose of 40μg delivered via suprachoroidal injection followed by a 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 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

 

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

 

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

 

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: 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: 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