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Research

Dedicated to personalized care in a compassionate setting

Retina Associates in Tucson, Arizona participates in many prestigious national clinical research trials, including a number of Macular Degeneration Clinical Trials. Clinical Trials are part of a nationwide effort to identify technologies or treatments for sight-threatening disorders. We are proud to offer the latest investigational treatments to our patients. We conduct this research as we know it will be beneficial to all of our patients, now and in the future.

Patients should feel free to contact Retina Associates directly. If you think you might qualify for a study or are interested in learning more, please call the Clinical Trials Department at 520-617-2805. 


 

Pending Recruitment

Study: KHK4951-002
Disease: Neovascular Age Related Macular Degeneration Sponsor: Kyowa Kirin Co., Ltd
Drug Name: KHK4951 Protocol Number: 4951-002 Enrollment Status: Pending
Full 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

Study: KHK4951-003
Disease: Diabetic Macular Edema Sponsor: Kyowa Kirin Co., Ltd Drug Name: KHK4951
Protocol Number: 4951-003 Enrollment Status: Pending
Full 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 Diabetic Macular Edema


Studies Open for Recruitment

Study: Parasol
Disease: Dry Age-Related Macular Degeneration Sponsor: Janssen Pharmaceuticals
Drug Name: AAVCAGsCD59
Protocol Number: 81201887MDG2001 Enrollment Status: Enrolling
Full Title: A Phase 2b, Randomized, Double-masked, Multicenter, Dose-ranging, Sham- controlled Clinical Trial to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD).


Studies Closed to Enrollment

Study: Luna
Disease: Wet Age-Related Macular Degeneration (Wet AMD) Sponsor: Adverum
Drug Name: ADVM-022 (Ixo-Vec) Protocol Number: ADVM 022-011 Enrollment Status: Closed
Full Title: A Multicenter, Randomized, Double-Masked Phase 2 Study to Assess Safety and Efficacy Of ADVM-022 (AAV.7m8-Aflibercept) In Anti-VEGF Treatment-Experienced Patients with Neovascular (Wet) Age-Related Macular Degeneration (nAMD).

Study: New Day
Disease: Diabetic Macular Edema (DME) Sponsor: Alimera
Drug Name: Iluvien
Protocol Number: 01-20-005 Enrollment Status: Closed
Full Title: A Randomized, Masked, Controlled Study of Intravitreal Iluvien Implant as Baseline Therapy in Patients with Early Diabetic Macular Edema.

Study: Avonelle-X
Disease: Neovascular Age-Related Macular Degeneration (Wet AMD) Sponsor: Genentech
Drug Name: Faricimab 6mg (Vabysmo) Protocol Number: GR42691 Enrollment Status: Closed
Full Title: A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Patients with Neovascular Age-Related Macular Degeneration.

Study: Shore
Disease: Neovascular Age-Related Macular Degeneration (Wet AMD) Sponsor: Opthea
Drug Name: OPT-302
Protocol Number: OPT-302-1004 Enrollment Status: Closed
Full Title: A Phase 3, Multicentre, Double-masked, Randomized Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination with Ranibizumab, Compared with Ranibizumab Alone, in Participants with Neovascular Age-related Macular Degeneration (nAMD).

Study: Condor
Disease: Proliferative Diabetic Retinopathy (PDR) Sponsor: Novartis
Drug Name: Brolucizumab (Beovu) Protocol Number: CRTH258D2301 Enrollment Status: Closed
Full Title: A 96-Week, Two-Arm, Randomized, Single-Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab 6 mg Compared to Pan-retinal Photocoagulation Laser in Patients with Proliferative Diabetic Retinopathy.

Study: Focus
Disease: Type II Diabetes Sponsor: Novo Nordisk
Drug Name: Semaglutide (Ozempic) Protocol Number: NN9535-4352 Enrollment Status: Closed
Full Title: Long-Term Effects of Semaglutide on Diabetic Retinopathy in Subjects with Type 2 Diabetes.
Study: Collaborative Ocular Oncology Group (COOG2)
Disease: Uveal Melanoma Sponsor: University of Miami Drug Name: None – Observational Protocol Number: COOG2
Enrollment Status: Enrollment Closed
Full Title: Uveal Melanoma Validation Study Number 2.

Study: AU-011-401
Disease: Primary Indeterminate Lesions and Small Choroidal Melanoma Sponsor: Aura Biosciences
Drug Name: None – Observational Protocol Number: AU-011-401 Enrollment Status: Closed
Full Title: A Registry of Patients with Primary Choroidal Melanoma (CM) or Indeterminate Lesions (ILS).

 

Closed Studies

Genentech, Canberra: June 2021- October 2023: A Randomized, Double Masked, 48-Week, Parallel-Group, Placebo Controlled, Proof of Concept Study to Investigate the Efficacy and Safety of RG7774 in Patients with Diabetes Mellitus Type 1 or Type 2 with Treatment Naïve Diabetic Retinopathy.

Genentech, Balaton: April 2021- October 2023: 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.

Genentech, Comino April 2021- October 2023: 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 Hemi-retinal Vein Occlusion.

Oxurion, Kalahari: November 2022 – December 2023: A Phase 2, Randomized, Multicentre Study to Assess the Dose Level of Multiple THR-149 Injections and to Evaluate the Efficacy and Safety of THR-149 Versus Aflibercept for the Treatment of Diabetic Macular Edema (DME).

Genentech, Rhone-X: November 2020- January 2024: Full Title: A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Patients with Diabetic Macular Edema (GR41987).

Genentech, Gallego: January 2021- July 2023: A Phase II, Multicenter, Randomized, Single- Masked, Sham−Controlled Study to Assess Safety, Tolerability, and Efficacy of Intravitreal Injections of FHTR2163 in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration (Gallego).

Aura, AU-011-202: August 2020- April 2023: A Phase II 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.

Aura, AU-001-101: February 2019 – January 2021. A Phase 1b/2 Open-Label, Ascending Single and Repeat Dose Clinical Trial Designed to Evaluate the Safety and Efficacy of Light-Activated AU-011 for the Treatment of Subjects with Small Primary Choroidal Melanoma.

Roche, TENAYA GR40306: February 2019 – May 2022. A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients with Neovascular Age-Related Macular Degeneration (nAMD).

Roche, YOSEMITE GR40349: July 2018 – September 2022. A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of RO6867461 in Patients with Diabetic Macular Edema (YOSEMITE).

Outlook Therapeutics, GREENLIGHT ONS-5010: June 2019 – June 2021. A Clinical Effectiveness, Multicenter, Randomized, Double-Masked, Controlled Study of the Efficacy and Safety of ONS- 5010 in Subjects with Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD).

Novartis, KINGFISHER CRTH258B2305: January 2020 – March 2022. A 12-Month, 2-Arm, Randomized, Double-Masked, Multicenter Phase III Study Assessing the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients with Visual Impairment Due to Diabetic Macular Edema.

Chengdu Kanghong Biotech Co., Ltd., PANDA-1 KHB-1801: January 2019 – September 2020. A 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.

Allergan, AGN-150998: August 2015 – June 2019. This is a safety and efficacy study of abicipar pegol in patients with neovascular age-related macular degeneration.

Allergan, MAPLE 1771-201-008: May 2018 – February 2019. Evaluation of Abicipar Pegol in Patients with Neovascular Age-Related Macular Degeneration.

Clearside, TOPAZ CLS1003-302: 2018. A Randomized, Masked, Controlled Trial to Study the Safety and Efficacy of Suprachoroidal CLS-TA with Intravitreal Anti-VEGF Agent in Subjects with Retinal Vein Occlusion.

Ophthotech (Iveric bio, Inc.) OPH2003B: 2017 – 2018. A Phase 2B Randomized, Double-Masked, Controlled Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura (Anti-C5 Aptamer) in Subjects with Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration.

Ophthotech (Iveric bio, Inc.) OPH2007: 2017 – 2018. A Phase 2A Open-Label Trial to Assess the Safety of Zimura (Anti-C5 Aptamer) Administered in Combination with Lucentis® 0.5mg in Treatment Naïve Subjects with Neovascular Age-Related Macular Degeneration.

Roche, STAIRWAY CR39521: 2017 – 2018. Simultaneous Blockade of Angiopoietin-2 And VEGF-A with the Bispecific Antibody RO6867461 (RG7716) for Extended Durability in the Treatment of Neovascular Age-Related Macular Degeneration.

Roche, BOULEVARD BP30099: 2016 – 2018. A Multiple-Center, Multiple-Dose, Randomized, Active Comparator-Controlled, Doubled-Masked, Parallel Group, 28-Week Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO6867461 Administered Intravitreally in Patients with Diabetic Macular Edema.

Tyrogenex, APEX X82-OPH-201: 2016 – 2018. A Randomized, Double-Masked, Placebo- Controlled, Dose-Finding, Non-Inferiority Study of X-82 Plus Prn Intravitreal (Ivt) Anti-VEGF Compared to Prn Ivt Anti-VEGF Monotherapy in Neovascular AMD.

Roche, OMASPECT GX30191: 2016 – 2018. A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Lampalizumab in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration Who Have Completed a Roche- Sponsored Study.

Ophthotech (Iveric bio, Inc.), OPH1004: May 2015 – 2017. A Phase III Randomized, Double- Masked, Controlled Trial to Establish the Safety and Effficacy of Intravitreous Administration of Fovista® (Anti PDGF-B Pegylated Aptamer) Administered in Combination with Either Avastin® or Eylea® Compared to Avastin® or Eylea® Monotherapy in Subjects with Subfoveal Neovascular Subfoveal Neovascular Age-Related Macular Degeneration.

Alcon, LHA510-2201: 2015 – 2016. A Randomized, Double-Masked, Vehicle-Controlled Proof-Of- Concept Study for Topically Delivered LHA510 as a Maintenance Therapy in Patients with Wet Age-Related Macular Degeneration (AMD).

StemCells Inc., RADIANT CL-AMD-201: 2015 – 2016. A Phase II Proof-Of-Concept Study of The Safety and Efficacy Of HUCNS-SC Subretinal Transplantation in Subjects with Geographic Atrophy of Age-Related Macular Degeneration.

Roche, SPECTRI GX29185: 2014 – 2018. A Phase III, Multicenter, Randomized, Double Masked, Sham-Controlled Study to Assess the Efficacy and Safety of Lampalizumab Administered Intravitreally to Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration.

Follow-Up CATT: 2014. Lucentis®- Avastin® Trial – Learning the Long-Term Effects of Treatments for Wet AMD On Vision and Eye Health Over A 5-6 Year Period.

Opthotech (Iveric bio, Inc.), OPH1003: 2013 – 2017. A Phase III Randomized, Double-Masked, Controlled Trial to Establish the Safety and Efficacy of Intravitreous Administration of Fovista® (Anti PDGF-B Pegylated Aptamer) Administered in Combination with Lucentis® Compared to Lucentis® Monotherapy in Subjects with Subfoveal Neovascular Age-Related Macular Degeneration.

Acucela Inc. (Kubota Vision Inc.), 4429-202: 2013 – 2016. A Phase 2b/3 Multicenter, Randomized, Double-Masked, Dose-Ranging Study Comparing the Efficacy and Safety of Emixustat Hydrochloride (ACU-4229) with Placebo for The Treatment of Geographic Atrophy Associated with Dry Age-Related Macular Degeneration.

Jaeb Center for Health Research, DRCR.net Protocol T: 2013 – 2014. A Comparative Effectiveness Study of Intravitreal Aflibercept, Bevacizumab and Ranibizumab for Diabetic Macular Edema.

OHR Pharmaceutical, Inc., OHR-002: 2012 – 2014. A Phase II Study of The Efficacy and Safety of Squalamine Lactate Ophthalmic Formulation 0.2% BID in Subjects with Neovascular Age-Related Macular Degeneration.

Pfizer, B1181003: 2012 – 2013. A Phase II Multicenter, Randomized, Double-Masked, Placebo- Controlled, Multi-Dose Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of RN6G (PF-04382923) in Subjects with Geographic Atrophy Secondary to Age-Related Macular Degeneration.

GlaxoSmithKline, MD7110852: 2011 – 2012. A Phase 2B Dosing-Ranging Study of Pazopanib Eye Drops Versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration.

Regeneron Pharmaceuticals, VGFT-OD-0910: 2010 – 2013. An Open-Label, Long-term, Safety and Tolerability Extension Study of Intravitreal VEGF Trap-Eye in Neovascular Age-Related Macular Degeneration.

Opthotech (Iveric bio, Inc.), OPH1001: 2010 – 2012. A Phase II, Randomized, Double- Masked, Controlled Trial to Establish the Safety and Efficacy of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) Given in Combination with Lucentis® in Subjects with Neovascular Age-Related Macular Degeneration.

Senten Inc. (Previous Sponsor MacuSight Inc.), AMD003: 2009 – 2010. A Phase II Randomized, Masked, Controlled Clinical Study to Assess the Safety and Efficacy of Lucentis® Plus Sirolimus Versus Lucentis® Plus Placebo in Patients with Sub-Foveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration.

CATT: February 2008 – 2012. Comparison of Age-Related Macular Degeneration Treatments Trials: Lucentis®-Avastin® Trial (CATT).

Genentech, FVF3426g: 2008 – 2010. An Open-Label, Multicenter Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Subjects with Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD) or Macular Edema Secondary to Retinal Vein Occlusion (RVO) Who Have Completed a Genentech-Sponsored Ranibizumab Study.

Genentech, RISE FVF4168g: 2007 – 2012. A Phase III, Double-Masked, Multicenter, Randomized, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab Injection in Subjects with Clinically Significant Macular Edema with Center Involvement Secondary to Diabetes Mellitus.

Regeneron Pharmaceuticals, VIEW1 VGFT-OD-0605: 2007- 2010. A Randomized, Double- Masked, Active-Controlled Phase III Study of The Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects with Neovascular Age-Related Macular Degeneration.

Genentech, CRUISE FVF4166g: 2007 – 2009. A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab Injection Compared with Sham in Subjects with Macular Edema Secondary to Central Retinal Vein Occlusion.

Genentech, BRAVO FVF4165g: 2007 – 2009. A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab Injection Compared with Sham in Subjects with Macular Edema Secondary to Branch Retinal Vein Occlusion.

Othera Pharmaceuticals, OMEGA OT-551-C04: 2007 – 2009. A Randomized, Double-Masked, Dose-Ranging, Multicenter Phase II Study Comparing the Safety and Efficacy of OT-551 with Placebo to Treat Geographic Atrophy Associated with Age-Related Macular Degeneration.

Genentech, FVF3689g: 2006 – 2007. A Phase 3b Single-Masked, Multicenter, Randomized Study to Evaluate the Safety and Tolerability of Ranibizumab in Naïve and Previously Treated Subjects with Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD).

Alcon Research, AART C-02-60: 2004 – 2009. Evaluation of Efficacy and Safety of Posterior Juxtascleral Injection of Anecortave Acetate Versus Sham Treatment for Subjects at Risk of Developing Choroidal Neovascularization.

Alcon Research, C-01-99: Phase III Study to Evaluate Anecortave Acetate vs. Visudyne for the Treatment of the Wet Form of Age-Related Macular Degeneration.

Eyetech Pharmaceuticals, EOP 1011: 2004 – 2006. A Phase II Randomized Dose‐Ranging, Double‐Masked, Multicenter Trial, in Parallel Groups, Determining Safety, Efficacy and PK of Intravitreous Injections of Pegaptanib Sodium Compared to Sham Injection for 30 Weeks in Patients with Recent Vision Loss Due to Macular Edema Secondary to CRVO.

National Eye Institute, VERTACL 05-EI-0064: 2004 – 2005. Multicenter, Randomized, Phase II Clinical Trial to Study the Effects of Preservative-Free Triamcinolone Acetonide and Avastin® in Combination with Photodynamic Therapy in Participants with Neovascular Age-Related Macular Degeneration.

Novartis, CBPD952A2308: 2007 – 2009. A 24-Month Randomized, Double-Masked, Controlled, Multicenter, Phase 3B Study Assessing Safety and Efficacy of Verteporfin Photodynamic Therapy Administered in Conjunction with Ranibizumab Monotherapy in Patients with Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration.

Eyetech Pharmaceuticals, EOP1005: 2004 – 2005. A Phase II Randomized, Controlled, Double- Masked, Dose-Finding, Multicenter, Comparative Trial, in Parallel Groups, to Establish the Safety and Preliminary Efficacy of Intravitreal Injections of EYE001 (Anti-VEGF

Pegylated Aptamer), Given Every 6 Weeks for 12 to 30 Weeks to Patients with Clinically Significant Diabetic Macular Edema (CSME) Involving the Center of the Macula.

Eyetech Pharmaceuticals, EOP1003: 2002 – 2007. A Phase II/III Randomized, Double‐Masked, Controlled, Dose‐Ranging, Multicenter Comparative Trial, in Parallel Groups, to Establish the Safety and Efficacy of Intravitreal Injections of EYE001 (Anti‐VEGF Pegylated Aptamer) Given Every 6 Weeks for 54 Weeks, in Patients with Exudative Age‐Related Macular Degeneration (AMD).

Eyetech Pharmaceuticals, EOP1004: 2002 – 2007. A Phase II/III Randomized, Double‐Masked, Controlled, Dose‐Ranging, Multicenter Comparative Trial, in Parallel Groups, to Establish the Safety and Efficacy of Intravitreal Injections of EYE001 (Anti‐VEGF Pegylated Aptamer) Given Every 6 Weeks for 54 Weeks, in Patients with Exudative Age‐Related Macular Degeneration (AMD).

National Eye Institute, Collaborative Ocular Melanoma Study (COMS): 1986 – 2000. The Collaborative Ocular Melanoma Study (COMS) is a set of long-term, multicenter, randomized controlled trials. In the trial for patients with tumors of medium size, enucleation and irradiation with an Iodine-125 episcleral plaque are compared on the basis of length of remaining life.

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