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: BALATON: 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 Branch Retinal Vein Occlusion.

Protocol Number: GR41984

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 6 months (through week 24) for a total of 6 injections.

Arm B: Aflibercept 2 mg injections monthly for 6 months (through week 24) 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 to 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

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

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

Title: The ARCHER Study: A Phase 2, Randomized, Parallel-Group, Double-Masked, 4-Arm, Sham-Controlled Study of the Efficacy, Safety, and Tolerability of ANX007 Administered by Intravitreal Injection in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration.

Protocol Number: ANX007-GA-01

Condition: Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

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

Arm 1: ANX007 5.0 mg/eye (0.10 mL) once every month (EM) for 12 months (12 doses).

Arm 2: ANX007 5.0 mg/eye (0.10 mL) once every other month (EOM) for 12 months (6 doses).

Arm 3: Sham injection every month (EM) for 12 months (12 sham injections).

Arm 4: Sham injection every other month (EOM) for 12 months (6 sham injections).

Final Visit for all arms: Month 18

Sponsor: Annexon, Inc.

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

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

Title: A Phase 3, Multicenter, Prospective, Randomized, Masked, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide (FA) Intravitreal 0.05 mg Insert (Yutiq 0.05 mg) in Subjects with Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye.

Protocol Number: EYP-2102-001

Condition: Chronic Non-Infectious Uveitis

Eligible subjects will be randomly assigned to receive either Yutiq 0.05 mg (the test article) or an intravitreal sham injection in the designated study eye.

Final Visit: Week 52

Sponsor: EyePoint Pharmaceuticals, Inc.

Royal Oak Site:

Principal Investigator: Lisa J. Faia, M.D.

Coordinators:

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

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

Daniel Korkis, BS 248-288-9132 ext. 1334

Title: A Longitudinal, Biomarker Study of Anti-VEGF, to Explore the Relationship Between Aqueous Humor Composition and Multimodal Retinal Images in Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema.

Protocol Number: BP41783

Condition: Neovascular Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME)

Eligible Subjects will be assigned into one of the two study arms based on condition:

nAMD Arm: Aflibercept 2 mg intravitreal injections three monthly doses and two bimonthly doses over 24 weeks according to local prescribing information.

DME Arm: Aflibercept 2 mg intravitreal injections five monthly doses and one bimonthly dose over 24 weeks according to the local prescribing information.

Final Visit for all arms: Week 24

Sponsor: F. Hoffman – La Roche Ltd

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 Ia, Multicenter, Open-Label, Single-Dose, Dose-Escalation Study Of The Safety, Tolerability, Pharmacokinetics, And Immunogenicity Of Intravitreal Injections Of RO7303359 In Patients With Geographic Atrophy Secondary To Age-Related Macular Degeneration.

Protocol Number: GR42163

Condition: Geographic Atrophy Secondary To Age-Related Macular Degeneration

Eligible Subjects will be assigned into one of the five cohorts:

Cohort A: Investigational medicinal product, RO7303359, 1 mg administered via intravitreal injection on Day 1. – Enrollment complete.

Cohort B: Investigational medicinal product, RO7303359, 3 mg administered via intravitreal injection on Day 1. – Enrollment complete.

Cohort C: Investigational medicinal product, RO7303359, 10 mg administered via intravitreal injection on Day 1.

Cohort D: Investigational medicinal product, RO7303359, 20 mg administered via intravitreal injection on Day 1.

Expansion Cohort: Investigational medicinal product, RO7303359, at the maximum tolerated dose either 1 mg, 3 mg, 10 mg or 20 mg administered via intravitreal injection on Day 1.

Final Visit for all arms: Week 12

Sponsor: Genentech, Inc.

Additional information about this trial is available at http://www.ClinicalTrials.gov

Royal Oak Site:

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

Coordinators:

Daniel Korkis, BS 248-288-9132 ext. 1334

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

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

Title: GALLEGOLE: A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intravitreal Injections of RO7171009 in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration.

Protocol Number: GR42558

Condition: Geographic Atrophy Secondary To Age-Related Macular Degeneration

Eligible subjects will receive RO7171009 by intravitreal injection or simulated injection in the study eye at a dosing frequency consistent with the original assigned dosing schedule in the parent study (every 4 weeks or every 8 weeks).

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 96

Sponsor: Genentech, 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: 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 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 Neovascualr (Wet) Age-related Macular Degeneration (wAMD)(DAYLIGHT).

Protocol Number: KS301P107

Condition: Neovascular (Wet) Age-related Macular Degeneration (wAMD)

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

Group A: KSI-301 5 mg intravitreal injections once every 4 weeks from Day 1 to Week 36.

Group B: Aflibercept 2 mg intravitreal injections once every 4 weeks for 3 monthly doses from Day 1 to Week 12 followed by a sham injection at Week 12. Aflibercept 2 mg intravitreal injections once every 8 weeks from Week 16 to Week 36. Sham injections will be administered at each monthly visit if an active treatment is not administered.

Final In-person Visit for all arms: Week 40

Safety Follow-up Telephone Call for all arms: Week 44 (for persons of child-bearing potential, an in-person visit is needed to have a pregnancy test)

Sponsor: Kodiak Sciences Inc.

Royal Oak Site:

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

Coordinators:

Daniel Korkis, BS 248-288-9132 ext. 1334

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

Title: HORIZON: A Phase II, Open-Label, Outcomes-Assessor Masked, Multicentre, Randomised, Controlled Study to Evaluate the Safety and Efficacy of Two Doses of GT005 Administered as a Single Subretinal Injection in Subjects With Geographic Atrophy Secondary to Age-Related Macular Degeneration.

Protocol Number: GT005-03

Condition: Geographic Atrophy Secondary to Age-Related Macular Degeneration

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

Medium dose GT005 (5E10 vg) Treatment Arm: Surgical procedure on day 1 with subretinal delivery of GT005 (2E10 vg) one time dose followed by visits on Day 2 and Day 3 to assess postoperative safety. Subjects will have study visits every 3 months (approximately 12 weeks).

High dose GT005 (2E11 vg) Arm: Surgical procedure on day 1 with subretinal delivery of GT005 (2E11 vg) one time dose followed by visits on Day 2 and Day 3 to assess postoperative safety. Subjects will have study visits every 3 months (approximately 12 weeks).

Control Arm: Subjects will have their first visit after randomization at Week 5. Following Week 5, subjects will have study visits every 3 months (approximately 12 weeks).

Final Visit for all arms: Week 96

Sponsor: Gyroscope Therapeutics, Ltd.

Royal Oak Site:

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

Coordinators:

Daniel Korkis, BS 248-288-9132 ext. 1334

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

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

Title: EXPLORE: A Phase 2, Outcomes Assessor-Masked, Multicentre, Randomised Study to Evaluate the Safety and Efficacy of Two Doses of GT005 Administered as a Single Subretinal Injection in Subjects With Geographic Atrophy Secondary to Age-Related Macular Degeneration.

Protocol Number: GT005-02

Condition: Geographic Atrophy Secondary to Age-Related Macular Degeneration

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

Low dose GT005 (2E10 vg) Treatment Arm: Surgical procedure on day 1 with subretinal delivery of GT005 (2E10 vg) one time dose followed by visits on Day 2 and Day 3 to assess postoperative safety. Subjects will have study visits every 3 months (approximately 12 weeks).

High dose GT005 (2E11 vg) Arm: Surgical procedure on day 1 with subretinal delivery of GT005 (2E11 vg) one time dose followed by visits on Day 2 and Day 3 to assess postoperative safety. Subjects will have study visits every 3 months (approximately 12 weeks).

Control Arm: Subjects will have their first visit after randomisation at Week 5. Following Week 5, subjects will have study visits every 3 months (approximately 12 weeks).

Final Visit for all arms: Week 96

Sponsor: Gyroscope Therapeutics, Ltd.

Royal Oak Site:

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

Coordinators:

Daniel Korkis, BS 248-288-9132 ext. 1334

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

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

Title: EXPLORE: A Phase 2, Outcomes Assessor-Masked, Multicentre, Randomised Study to Evaluate the Safety and Efficacy of Two Doses of GT005 Administered as a Single Subretinal Injection in Subjects With Geographic Atrophy Secondary to Age-Related Macular Degeneration.

Protocol Number: GT005-02

Condition: Geographic Atrophy Secondary to Age-Related Macular Degeneration

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

Low dose GT005 (2E10 vg) Treatment Arm: Surgical procedure on day 1 with subretinal delivery of GT005 (2E10 vg) one time dose followed by visits on Day 2 and Day 3 to assess postoperative safety. Subjects will have study visits every 3 months (approximately 12 weeks).

High dose GT005 (2E11 vg) Arm: Surgical procedure on day 1 with subretinal delivery of GT005 (2E11 vg) one time dose followed by visits on Day 2 and Day 3 to assess postoperative safety. Subjects will have study visits every 3 months (approximately 12 weeks).

Control Arm: Subjects will have their first visit after randomisation at Week 5. Following Week 5, subjects will have study visits every 3 months (approximately 12 weeks).

Final Visit for all arms: Week 96

Sponsor: Gyroscope Therapeutics, Ltd.

Royal Oak Site:

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

Coordinators:

Daniel Korkis, BS 248-288-9132 ext. 1334

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

Opal Potter, MS 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: 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 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: 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