Research

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 520-733-8584.

Current Studies

STUDY: Shore
Disease: Wet AMD
Sponsor: Opthea
Drug Name: Opt302
Control: lucentis
Protocol number: OPT-302-1004
Enrollment status: ENROLLING
Full title: A Phase 3, Multicentre, Double-masked, Randomised 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: BALATON
DISEASE: BRVO
SPONSOR: ROCHE
DRUG: FARCIMAB 6mg OR VABYSMO
CONTROL: AFLIBERCEPT
PROTOCOL NUMBER: GR41984
ENROLLMENT STATUS: ENROLLMENT CLOSED
FULL TITLE: A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, ACTIVE COMPARATOR-CONTORLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FARICIMAB IN PATIENTS WITH MACULAR EDEMA SECONDARY TO BRANCH RETINAL VEIN OCCLUSION

STUDY: COMINO
SPONSOR: ROCHE
DRUG: FARCIMAB 6mg OR VABYSMO
CONTROL: AFLIBERCEPT
PROTOCOL NUMBER: GR41986
ENROLLMENT STATUS: ENROLLMENT CLOSED
FULL TITLE: A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, ACTIVE COMPARATOR-CONTORLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FARICIMAB IN PATIENTS WITH MACULAR EDEMA SECONDARY TO CENTRAL RETINAL OR HEMIRETINAL VEIN OCCLUSION

STUDY: AU-011-202
DISEASE: Primary indeterminate lesions and small choroidal melanoma
SPONSOR: AURA BIOSCIENCES
DRUG: Light Activated AU-011
PROTOCOL NUMBER: AU-011-202
ENROLLMENT STATUS: ENROLLING
FULL 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

STUDY: GALLEGO
DISEASE: GA secondary to DRY AMD
SPONSOR: ROCHE
DRUG: FHTR2163 OR GALEGENIMAB
PROTOCOL NUMBER: GR40973
ENROLLMENT STATUS: ENROLLMENT CLOSED
FULL TITLE: 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)

STUDY: New Day Study
DISEASE: DME
SPONSOR: Alimera
DRUG: ILUVIEN
PROTOCOL NUMBER: 01-20-005
ENROLLMENT STATUS: ENROLLING
FULL TITLE: A Randomized, Masked, Controlled Study of Intravitreal ILUVIEN Implant as Baseline Therapy in Patients with Early Diabetic Macular Edema

STUDY: RHONE-X (YOSEMITE extension)

STATUS: We are activated and can enroll any YOSEMITE subject on Day 100 visit.
DISEASE: DME
SPONSOR: ROCHE
DRUG: FARCIMAB
PROTOCOL NUMBER: GR41987
ENROLLMENT STATUS: WE CAN ENROLL ANY SUBJECT WHO IS CURRENTLY IN THE YOSEMITE study
FULL TITLE: A MULTICENTER, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF FARICIMAB IN PATIENTS WITH DIABETIC MACULAR EDEMA

STUDY: COOG2  (Collaborative Ocular Oncology Group)
DISEASE: Uveal Melanoma
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: NONE
PROTOCOL NUMBER: AU-011-401
ENROLLMENT STATUS: Enrollment closed/ active subjects
FULL TITLE: A registry of patients with primary choroidal melanoma (CM) or indeterminate lesions (ILS).

STUDY: AVONELLE-X
Disease: WET AMD
Sponsor: Roche
Drug Name: farcimab
Control: EYLEA
Protocol Number GR40306
Enrollment status: WE CAN ENROLL ANY SUBJECT WHO IS CURRENTLY IN THE Tenaya STUDY
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: Condor
Disease: Proliferative diabetic Retinopathy
Sponsor: Novartis
Drug Name: Beavu
Control: PRP laser
Protocol number: CRTH258D2301
Enrollment status: ENROLLMENT CLOSED
Full title: A 96-week, two-arm, randomized, single-masked, multicenter, phase III study assessing the efficacy and safety of brolucizumab 6mg compared to panretinal photocoagulation laser in patients with proliferative diabetic retinopathy

STUDY: Canberra
Disease: Diabetic retinopathy
Sponsor: ROCHE
Drug: RG7774 (Pill)
Control: Placebo
Enrollment status: ENROLLMENT CLOSED

FULL TITLE: 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.

STUDY: LUNA
DISEASE: Wet Age-Related Macular Degeneration
SPONSOR: Adverum
DRUG: ADVM-022 or ixoberogene soroparvovec (Ixo-vec)
PROTOCOL NUMBER: ADVM 022-011
ENROLLMENT STATUS: expected to start Sept 2022
FULL TITLE: A Multi‑Center, 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: KALAHARI
Disease: DME
Sponsor: Oxurion
Drug Name: THR-149
Control: AFLIBERCEPT
Protocol number: THR-149-002
Enrollment status: EXPECTED TO OPEN BY SEPT 2022
Full title: A Phase 2, Randomised, 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 Oedema (DME)

STUDY: FOCUS
Disease: DIABETIES
Sponsor: Novo Nordisk A/S
Drug Name: Semaglutide
Protocol number: NN9535-4352
Enrollment status: ENROLLMENT CLOSED
Full title: Long-term Effects of Semaglutide on Diabetic Retinopathy in Subjects With Type 2 Diabetes

Pending Studies

Studies that we have reached out to the sponsor/signed CDA

 Site has been selected to participate. Budget negotiation is being negotiated. Contract has been signed. BCVA examiners need certification. Disease: Diabetic retinopathy
SPONSOR: JANSSEN PHARMACEUTICALS
ENROLLMENT STATUS: PENDING
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)

CLOSED OUT

STUDY: YOSEMITE
DISEASE: DME
SPONSOR: ROCHE
DRUG: FARCIMAB 6mg (scheduled or PTI)
CONTROL: Aflibercept 2mg
PROTOCOL NUMBER: GR40349
ENROLLMENT STATUS: study closed ENROLLMENT CLOSED/ Subjects have exited
NUMBER OF SUBJECTS: 6
FULL TITLE: A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (YOSEMITE)

STUDY: PANDA
DISEASE: Wet AMD
SPONSOR: Chengdu Kanghong Biotech Co., Ltd
DRUG: Conbercept (0.5mg or 1mg)
CONTROL: Aflibercept 2mg
PROTOCOL NUMBER: KHB1801
ENROLLMENT STATUS: Study closed ENROLLMENT CLOSED/ Subjects have exited
NUMBER OF SUBJECTS: 2 active (7 total enrolled)
FULL TITLE: 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 (AMD) (PANDA-1)

STUDY: KINGFISHER
DISEASE: DME
SPONSOR: Novartis
DRUG: Brolucizumab 6 mg
CONTROL: Aflibercept 2mg
PROTOCOL NUMBER:  CRTh258B2305
ENROLLMENT STATUS: study closed ENROLLMENT CLOSED /Subjects have exited
NUMBER OF SUBJECTS: 1
FULL TITLE: 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 (KINGFISHER)

STUDY: GREENLIGHT (NORSE 3)
DISEASE: Wet AMD, DME, CRVO, or anything disease that requires Anti-VEGF
SPONSOR: Outlook Theraputics
DRUG: ONS-5010 (branded Bevacizumab 1.25 mg)
CONTROL: Ranibizumab
PROTOCOL NUMBER: ONS-5010-003
ENROLLMENT STATUS: ENROLLMENT CLOSED.  We missed out on enrollment
NUMBER OF SUBJECTS: 0
FULL TITLE: A 3-Month study to assess the safety of ONS-5010 In subjects with visual impairment due to retinal disorders, NORSE 3.

STUDY: GREENLIGHT (NORSE 2)
DISEASE: Wet AMD
SPONSOR: Outlook Theraputics
DRUG: ONS-5010 (branded Bevacizumab 1.25 mg)
CONTROL: Ranibizumab
PROTOCOL NUMBER: ONS-5010-002
ENROLLMENT STATUS: Study closed out ENROLLMENT CLOSED/ Subjects have exited
NUMBER OF SUBJECTS: 16 subjects randomized (14 currently in follow up)
FULL TITLE: 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

STUDY: AURA 101
DISEASE: Choroidal Melanoma
SPONSOR: Aura Biosciences
DRUG: Light Activated AU-011 40µg  (belzupacap sarotalocan)
PROTOCOL NUMBER: AU-011-101
ENROLLMENT STATUS: ENROLLMENT CLOSED
NUMBER OF SUBJECT ENROLLED: 3
FULL TITLE: 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

STUDY: TENAYA
DISEASE: Wet AMD
SPONSOR: ROCHE
DRUG: FARCIMAB 6mg
CONTROL: Aflibercept 2mg
PROTOCOL NUMBER: GR40306
ENROLLMENT STATUS: ENROLLMENT CLOSED
NUMBER OF SUBJECTS: 9
FULL TITLE: 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 (TENAYA)

Previous Studies

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

Ophthotech-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 AgeRelated Macular Degeneration

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

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 Ramdomized, Double-Masked, Placebo Controlled, Dose-Finding, Non-Inferiority Study or X-82 Plus Prn Intravitreal (Ivt) AntiVEGF 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

OPH1004 May 2015-2017 A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Either Avastin® or Eylea® Compared to Avastin® or Eylea® Monotherapy.

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). Stem Cells 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 3, 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 -OPH1003-:2013-2017 A Phase 3 Randomized, Double-Masked, Controlled Trial to Establish the Safety and Efficacy of Intravitreous Administration of Fovista (Anti Pdgf-B Pegylatedaptamer) Administered in Combination with Lucentis; Compared to
Lucentis® Monotherapy in Subjects with Subfoveal Neovascular Age-Related Macular Degeneration.

Acucela Inc. 4429-202: 2013-2016 A Phase 2b/3 Multicenter, Randomized, DoubleMasked, 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.

Diabetic Retinopathy Clinical Research Network (DRCR) –Protocol T: 2013-2014 A Comparative Effectiveness Study of Intravitreal Afibercept, 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 Solution 0.2% Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration.

Pfizer B1181003: 2012-2013 A Phase II Multi-Center, 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 IIB, Dosing Range Study of Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections in Adults with Choroidal Neovascularization Secondary to Age-Related Macular Degeneration.

Regeneron Pharmaceuticals VGFT-OD-0910.02: 2010-2013 An Open-Label, LongTerm, Safety and Tolerability Extension Study of Intravitreal VEGF Trap-Eye in Neovascular Age-related Macular Degeneration.

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

MacuSight AMD003: 2009-2010 A Phase II Study of an Ocular Sirolimus (Rapamycin) Formulation in Combination with Lucentis® in Patients with Age-Related Macular Degeneration.

CATT: February 2008- 2012 A randomized, Multicenter study for Subjects with Neovascular Age-Related Macular Degeneration.

Genentech FVF3426g: 2008 – 2010 An Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Subjects with Choroidal Neovascularization Secondary to Age-Related Macular Degeneration or Macular Edema Secondary to Retinal Vein
Occlusions.

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

Regeneron Pharmaceuticals VGFT-OD-0605: 2007- 2010 A Phase III Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects with Exudative Age-Related Macular Degeneration.

Genentech FVF4166g: 2007 – 2009 A Phase III, Randomized, Double-Masked, Sham Injection- Controlled Study of Ranibizumab in Subjects with Macular Edema Secondary to Central Retinal Vein Occlusion.

Genentech FVF4165Gg: 2007 – 2009 A Phase III, Randomized, Double-Masked, Sham Injection-Controlled Study of Ranibizumab in Subjects with Macular Edema Secondary to Branch Retinal Vein Occlusion.

Othera OT-551-C04: 2007-2009 A Phase II, Randomized, Double-Masked, DoseRanging, Multi-Center, 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 III Study to Evaluate Ranibizumab in Subjects with Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD).

Alcon 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 C-01-99: Evaluation of Efficacy and Safety of Posterior Juxtascleral Injection of anecortave Acetate Versus Visudyne in Wet Age-Related Macular Degeneration

Eyetech EOP 1011: 2004-2006 A Phase II Randomized Dose‐Ranging, Double‐Masked, Multi‐Center Trial, in Parallel Groups, to Determine the Safety, Efficacy and Pharmacokinetics of Intravitreal Injections of Pegaptanib Sodium Compared to Sham Injection for 30 Weeks in Patients With Recent Vision Loss Due to Macular Edema Secondary to Central Retinal Vein Occlusion.

Vertacl (NEI): 2004-2005 A phase II/III, Multicenter, Randomized, Prospective trial to study effects of Preservative Free Triamcinolone Acetonide as Adjunct to Visudyne Treatment of Wet Age-Related Macular Degeneration.

Novartis VIO: A Phase III, Multicenter Double-Masked, Placebo-Controlled, Randomized Study to Determine if Photodynamic Therapy with Verteporfin Reduces the Risk of Vision Loss in Patients with Subfoveal Occult Choroidal Neovascularization
Secondary to Age-Related Macular Degeneration (AMD).

Eyetech EOP 1005: 2004 – 2005 A Phase II Randomized, Controlled, Double-Masked, Dose-Finding, Multi-Center, 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 1003: 2002-2007 A Phase II/III Randomized, Double‐Masked, Controlled, Dose‐Ranging, Multi‐Center 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 EOP 1004: 2002-2007 A Phase II/III Randomized, Double‐Masked, Controlled, Dose‐Ranging, Multi‐Center 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).

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.