Neovascular Age-Related Macular Degeneration (Wet AMD)

Sponsor - Genentech (Closed to Enrollment)

Study: AVONELLE-X GR42691
A MULTICENTER, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF FARICIMAB IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (AVONELLE-X)
https://clinicaltrials.gov/ct2/show/NCT04777201?term=AVONELLE-X&draw=2&rank=1

Sponsor – Regenxbio (Open to Enrollment)

Study: ASCENT RGX-314-3101
A Randomized, Partially Masked, Controlled, Phase 3 Clinical
Study to Evaluate the Efficacy and Safety of RGX-314 Gene
Therapy in Participants with nAMD
https://clinicaltrials.gov/ct2/show/NCT04832724?term=RGX-314&draw=2&rank=1

Sponsor – Kodiak Sciences (Closed to Enrollment)

Study: DAYLIGHT KS301P107
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
Neovascular (Wet) Age-related Macular Degeneration (wAMD)
https://clinicaltrials.gov/ct2/show/NCT04964089?term=Kodiak+DAYLIGHT&draw=2&rank=1

Sponsor - F. Hoffmann-La Roche Ltd. (Open to Enrollment)

Study: BURGUNDY BP41670
A TWO-PART, PHASE I STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF RO7250284 FOLLOWING INTRAVITREAL ADMINISTRATION OF UNMASKED MULTIPLE ASCENDING DOSES AND MASKED SUSTAINED DELIVERY FROM THE PORT DELIVERY SYSTEM IN PATEINTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION
https://clinicaltrials.gov/ct2/show/NCT04567303?term=BP41670&draw=2&rank=1

Sponsor - Bayer/Regeneron (Closed to Enrollment)

Study: PULSAR 20968
Randomized, Double-Masked, Active-Controlled, Multi-Center Study Of Efficacy And Safety Of High Dose Aflibercept In Patients With Neovascular Age-Related Macular Degeneration
https://clinicaltrials.gov/ct2/show/NCT04423718?term=PULSAR+20968&draw=2&rank=1


Sponsor – Genentech/Roche (Open to Enrollment) 

Study: PORTAL GR40549
A MULTICENTER, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF THE PORT DELIVERY SYSTEM WITH RANIBIZUMAB IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION
https://clinicaltrials.gov/ct2/show/NCT03683251?term=PORTAL&cond=Neovascular+Age-related+Macular+Degeneration&rank=1 

Previous “Wet” AMD Studies:

Principal Investigator, 2020 - 2022
Sponsor – Genentech/Roche
Study: ARCHWAY GR40548
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 PATIENT WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION
https://clinicaltrials.gov/ct2/show/NCT03677934?term=ARCHWAY&cond=Neovascular+Age-related+Macular+Degeneration&rank=1

Principal Investigator, 2020 - 2022
Sponsor – Novartis
Study: TALON RTH258
A 64-week, two-arm, randomized, double-masked, multi-center, phase IIIb study assessing the efficacy and safety of brolucizumab 6 mg compared to aflibercept 2 mg in a treat-to-control regimen in patients with neovascular age-related macular degeneration (TALON)

Principal Investigator, 2020 - 2022
Sponsor - Novartis
Study: MERLIN CRTH258AUS04
A multicenter, randomized, double-masked Phase 3a study to assess safety and efficacy of brolucizumab 6mg q4 weeks compared to aflibercept 2mg q4 weeks in patients with neovascular age-related macular degeneration (nAMD) with persistent retinal fluid (MERLIN)
https://clinicaltrials.gov/ct2/show/NCT03710564?term=MERLIN&rank=1

Principal Investigator, 2020 - 2022
Sponsor - Genentech/Roche
Study: TENAYA GR40306
A PHASE III, MULTICENTER, RANDOMIZATION, DOUBLE-MASKED, ACTIVE COMPARATOR-CONTROLLED STUDY TO EVALUATE FARICIMAB IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION
https://clinicaltrials.gov/ct2/show/NCT03823287?term=TENAYA&rank=1

Principal Investigator, 2020 - 2022
Sponsor – Chengdu Kanghong Biotechnology
Study: PANDA KHB-1801
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
https://clinicaltrials.gov/ct2/show/NCT03577899?term=PANDA&cond=Neovascular+Age-related+Macular+Degeneration&rank=2 

Principal Investigator, 2020 - 2022

Sponsor - Kodiak Sciences, Inc.
Study: DAZZLE KSI-CL-201
A Phase 2, Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center Study to Investigate the Efficacy and Safety of Repeated Intravitreal Administration of KSI-301 in Subjects with Neovascular (Wet) Age-Related Macular Degeneration

Principal Investigator, 2020 - 2022
Sponsor – Regeneron
Study: CANDELA VGFTe (HD)-AMD-1905 
A RANDOMIZED, SINGLE-MASKED, ACTIVE-CONTROLLED PHASE 2 STUDY OF THE SAFETY, TOLERABILITY, AND EFFICACY OF REPEATED DOSES OF HIGH-DOSE AFLIBERCEPT IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION

Principal Investigator, 2020 - 2022
Sponsor -  Roche
Study: BLUETAIL1 BP40923
A MULTI-CENTER, NON-RANDOMIZED, OPEN-LABEL, MULTIPLE ASCENDING DOSE STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF RO7200394 FOLLOWING INTRAVITREAL ADMINISTRATION IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION.

Principal Investigator, 2020-2020
Sponsor: Outlook Therapeutics 
Study: NORSE TWO
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)

Principal Investigator 2019 - 2020
Sponsor: Graybug Vision
Study: ALTISSIMO
A Phase 1 / 2 Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of an Intravitreal Depot Formulation of Sunitinib Malate (GB-102) in Subjects with Neovascular Age-related Macular Degeneration.
https://clinicaltrials.gov/ct2/show/NCT03953079?term=graybug&rank=1

Principal Investigator 2018 - 2019
Sponsor: Panoptica (Closed to Enrollment)
Study: Panoptica (N/A)
A Randomized, Double Masked, Uncontrolled, Multicenter Phase I/II Study to Evaluate Safety and Tolerability of PAN-90806 Eye Drops, Suspension in Treatment-Naïve Participants with Neovascular Age-Related Macular Degeneration (AMD)
https://clinicaltrials.gov/ct2/show/NCT03479372?term=panoptica&cond=Age+Related+Macular+Degeneration&cntry=US&rank=1

Principal Investigator 2018 - 2020
Sponsor: Samsung Bioepis Co., LTD
Study: Samsung (N/A)
A PHASE III RANDOMISED, DOUBLE-MASKED, PARALLEL GROUP, MULTICENTER STUDY TO COMPARE THE EFFICACY SAFETY, PARMACOKINETICS AND IMMUNOGENICITY BETWEEN SB11 (PROPOSED RANIBIZUMAB BIOSIMILAR) AND LUCENTIS IN SUBJECTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION
https://clinicaltrials.gov/ct2/show/NCT03150589?term=samsung&cond=Age+Related+Macular+Degeneration&cntry=US&rank=1

Principal Investigator 2017 - 2019

Sponsor: Genentech
Study: LADDER
A PHASE II, MULTICENTER, RANDOMIZED,  ACTIVE TREATMENT-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF THE RANIBIZUMAB PORT DELIVERY SYSTEM FOR SUSTAINED DELIVERY OF RANIBIZUMAB IN PATIENTS WITH SUBFOVEAL NEOVASCULAR AGE-RELATED MACULAR DEGENERATION
https://clinicaltrials.gov/ct2/show/NCT02510794?term=LADDER&rank=7

Principal Investigator 2016 - 2017
Sponsor: Ohr
Study: MAKO
A Phase III Study of the Efficacy and Safety of Squalamine Lactate Ophthalmic Solution, 0.2% Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration
https://clinicaltrials.gov/ct2/show/NCT02727881?term=MAKO&rank=5

Principal Investigator 2015 - 2018
Sponsor: Allergan
Study: SEQUOIA
SAFETY AND EFFICACY OF ABICIPAR PEGOL (AGN-150998) IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION
https://clinicaltrials.gov/ct2/show/NCT02462486?term=ALLERGAN+SEQUOIA&rank=1

Principal Investigator 2014 - 2017
Sponsor: Tyrogenex
Study: APEX
A RANDOMIZED, DOUBLE-MASKED, PLACEBO-CONTROLLED, DOSE-FINDING, NON-INFERIORITY STUDY OF X-82 PLUS prn EYLEA  COMPARED TO prn EYLEA  MONOTHERAPY IN NEOVASCULAR AMD
https://clinicaltrials.gov/ct2/show/NCT02348359?term=X-82&rank=2

Principal Investigator 2016 - 2017
Sponsor: Regeneron
Study: ONYX
A RANDOMIZED, DOUBLE-MASKED, ACTIVE-CONTROLLED PHASE 2 STUDY OF THE EFFICACY, SAFETY, AND TOLERABILITY OF REPEATED DOSES OF INTRAVITREAL REGN910-3 IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION
https://clinicaltrials.gov/ct2/show/NCT02713204?term=Regeneron+neovascular+AMD&rank=7

Principal Investigator 2015 - 2017
Sponsor: Opthea
A PHASE 1 DOSE ESCALATION STUDY EVALUATING THE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF OPT-302 IN COMBINATION WITH RANIBIZUMAB IN SUBJECTS WITH WET AMD
https://clinicaltrials.gov/ct2/show/NCT02543229?term=Opthea&rank=1

Principal Investigator 2015 - 2017
Sponsor: Regeneron
Study: CAPELLA
A PHASE 2, DOUBLE-MASKED, RANDOMIZED, CONTROLLED, MULTIPLE-DOSE, REGIMEN-RANGING STUDY OF THE EFFICACY AND SAFETY OF INTRAVITREAL REGN2176-3 IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION
https://clinicaltrials.gov/ct2/show/NCT02418754?term=2176&rank=1

Principal Investigator 2015 - 2016
Sponsor: Iconic
Study: EMERGE
A PHASE 2 RANDOMIZED, DOUBLE-MASKED, MULTICENTER, ACTIVE-CONTROLLED STUDY EVALUATING ADMINISTRATION OF REPEATED INTRAVITREAL DOSES OF hI-con1 IN PATIENTS WITH CHOROIDAL NEOVASCULARIZATION SECONDARY TO AGE-RELATED MACULAR DEGENERATION
https://clinicaltrials.gov/ct2/show/NCT02358889?term=EMERGE&rank=4

Principal Investigator 2015 - 2016
Sponsor: Neurotech
A MULTI-CENTER, TWO STAGE, OPEN-LABEL PHASE I AND RANDOMIZED ACTIVE CONTROLLED, MASKED PHASE II STUDY TO EVALUATE THE SAFETY AND EFFICACY OF INTRAVITREAL IMPLANTATION OF NT-503-3 ENCAPSULATED CELL TECHNOLOGY COMPARED WITH EYLEA  FOR THE TREAMENT OF RECURRENT SUBFOVEAL CHOROIDAL NEOVASCULARIZATION (CNV) SECONDARY TO AGE-RELATED MACULAR DEGENERATION
https://clinicaltrials.gov/ct2/show/NCT02228304?term=Neurotech&rank=14

Principal Investigator 2014 - 2016
Sponsor: PanOptica
A PHASE I OPEN-LABEL, MUTLI-CENTER TRIAL WITH RANDOMIZATION TO DOSE TO EVALUATE THE SAFETY AND TOLERABILITY OF TOPICAL OCULAR PAN-90806 IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (AMD)
https://clinicaltrials.gov/ct2/results?term=PANOptica&Search=Search

Principal Investigator - 2013-2015
Phase 2 study of the efficacy and safety of Squalamine Lactate Ophthalmic Solution 0.2% twice daily in subjects with neovascular age-related macular degeneration

Principal Investigator, 2013 - 2015
Study: RE-VIEW
An Open-Label Study of the Efficacy, Safety, and Tolerability of Intravitreal Administration of VEGF Trap-Eye (Intravitreal Aflibercept Injection) in Patients with Neovascular Age-Related Macular Degeneration

Sub-Investigator, 2010 - 2011
A Randomized, Sham-Injection Controlled, Double-Masked, Multicenter Trial of Ocriplasmin Intravitreal Injection for Treatment of Focal Vitreomacular Adhesion in Subjects with Exudative Age-Related Macular Degeneration (AMD)

Sub-Investigator, 2009 - 2012
Study: HARBOR
A Phase III, Multicenter, Randomized, Double-Masked Study Comparing the Efficacy and Safety of 0.5-mg and 2.0-mg Ranibizumab Administered Monthly or on an As-Needed Basis (PRN) with a Safety Run-In of a Single Dose of 2.0-mg Ranibizumab with Subfoveal Neovascular Age-Related Macular Degeneration

Sub-Investigator, 2008 - 2009
A 26-Week, Open Label Study to Assess the Safety and Efficacy of 700µg Dexamethasone Posterior Segment Drug Delivery System Applicator System as Adjunctive Therapy to Lucentis in the Treatment of Subjects with Choroidal Neovascularization Secondary to Age-Related Macular Degeneration

Sub-Investigator, 2008 - 2009
A Phase 2 , 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

Sub-Investigator, 2007 - 2009
A Phase 3, Randomized, Double-Masked, Parallel-Assignment Study of Intravitreal Bevasiranib Sodium, Administered every 8 or 12 weeks as Maintenance Therapy Following Three Injections of Lucentis Compared with Lucentis Monotherapy every 4 weeks in Patients with Exudative Age-Related Macular Degeneration (AMD)

Sub-Investigator - 2008
Randomized, controlled trial of VEGF Trap in patients with neovascular AMD

Sub-Investigator, 2008
Study: DENALI
A 24-month Randomized, Double-masked, Controlled, Multicenter, Phase IIIB Study Assessing Safety and Efficacy of Verteporfin Photodynamic Therapy Administered in Conjunction With Ranibizumab Versus Ranibizumab Monotherapy in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration

Sub-Investigator, 2006 - 2008
A 24-month randomized, double-masked, sham-controlled, multicenter, phase IIIB study comparing photodynamic therapy with verteporfin plus two different dose regimens of intravitreal triamcinolone acetonide (1mg and 4mg) versus Visudyne plus intravitreal pegaptanib (Macugen) in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration

Sub-Investigator, 2006 - 2008 
An Evaluation of Efficacy and Safety of Posterior Juxtascleral Administrations of Anecortave Acetate for Depot Suspension (15mg or 30mg) versus Sham Administration in Patients at Risk for Developing Sight Threatening Choroidal Neovascularization Due to Exudative Age Related Macular Degeneration

Sub-Investigator, 2002 - 2005
An Evaluation of Efficacy and Safety of Posterior Juxtascleral Injections of Anecortave Acetate 15 mg (0.5 mg of 30 mg/ml Anecortave Acetate Sterile Suspension) versus Visudyne in Patients with Subfoveal Exudative Age-Related Macular Degeneration (AMD) Eligible for Initial Treatment with Photodynamic Therapy (PDT) Using Visudyne.

Principal Investigator, 2002 - 2005
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).

Sub-Investigator, 2000 - 2001
A Phase III, Non-Randomized, Multi-Center, Unmasked Non-placebo Controlled Study of Verteporfin and Macular Degeneration (VAM).

Sub-Investigator, 2005 - 2007
Anecortave Acetate 15 mg Administered Every 3 Months Versus Anecortave Acetate 15 mg Administered Every 6 Months Versus Anecortave Acetate 30 mg Administered Every 6 Months in Patients With Exudative AMD.

Sub-Investigator, 2005
A Phase 3 Multi-Center, Randomized, Double-Masked, Controlled Study of Squalamine Lactate for Injection for the Treatment of Subfoveal Choroidal Neovascularization Associated with Age-Related Macular Degeneration.

Sub-Investigator, 2005
A 24-month Randomized, Double-Masked, Sham-Controlled, Multi-Center, Phase 111B Study Comparing Photodynamic Therapy with Verteporfin Plus Two Different Dose Regimens of Intravitreal Triamcinolone Acetonide (1mg and 4mg) versus Visudyne Plus Intravitreal Pegaptanib (Macugen) in Patients with Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration.

Sub-Investigator, 1998 - 1999
A Phase III Randomized, Multi-Center, Double-Masked, Placebo-Controlled Parallel Group Study of Tin Ethyl Etiopurpurin (SnET2) Photodynamic Therapy in the Treatment of Subfoveal Choroidal Neovascularization Associated with Age-Related Macular Degeneration.