Current Trials

About Clinical Trials

What is a Clinical Trial?

A clinical trial is a study in human volunteers designed to answer a specific health question about the safety or efficacy of a drug, a device, or other interventions. These allow doctors to examine the benefits and risks of using these drugs. Clinical trials are designed to find safe treatments that work in people and new ways to improve health.

Why Participate in a Clinical Trial?

Clinical trials can either enhance a treatment or be a treatment option. Here are a few reasons people choose to participate in studies:

• Many treatment drugs and tests are free to study participants

• Successful clinical trials may improve the length and quality of life for study participants

• Clinical trials provide an opportunity to take positive action by contributing to the understanding of a disease or condition and by furthering treatment options available to others

• Patients in successful clinical trials are the first to benefit from these cutting-edge treatments

How is a Clinical Trial Conducted?

A consent form, which explains what is involved in the study, is provided to and reviewed with you by members of the Research Team. Being in a study is completely voluntary, and you can change your mind at any time, even if you have signed the consent form.

All studies have what are known as "Inclusion and Exclusion Criteria," which explain what is involved in the study and outline who may participate. You will be monitored carefully during the study, and you will likely be contacted by the Research Team after study procedures are completed. Some studies require more tests and doctor/clinic visits than you would normally have for an illness or condition.

How are Clinical Trial Participants Protected?

US federal agencies including the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) oversee much of the clinical trials in the U.S. to protect the rights and welfare of study participants. Institutional Review Boards (IRBs) oversee the centers where clinical trials are conducted and ensure that a clinical trial is ethical and that study participants’ rights are protected. As a study participant, you have access to the IRB, a volunteer advocate, the physician and the staff conducting the clinical trial.

For more information on participating in clinical trials, please visit:
www.fda.gov
www.nih.gov
www.clinicaltrials.gov

Regeneron VGFTe-HD-DME-1934 PHOTON

Phase 2/3, randomized, double-masked, active controlled study of the efficacy and safety of high dose aflibercept in patients with diabetic macular edema.

Genentech Archway Clinical Trial 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 patients with Neovascular age-related Macular Degeneration.

Genentech GR40550 PAGODA

Phase 3, multi-center, 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.

Genentech Yosemite Clinical Trial GR40349

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.

Genentech CHROMA Protocol #GX29176

A Phase III, multicenter, randomized, double-masked, sham-controlled study of efficacy and safety of 10 mg Lampalizumab intravitreal injections administered every 30 or 45 days to patients with geographic atrophy secondary to age-related macular degeneration.

Diabetic Retinopathy Clinical Research Network Protocol AC

Aflibercept vs. Bevacizumab with deferred Aflibercept for DME.

Alkeus Saga

A phase 2/3 multicenter, Randomized, double-masked, parallel-group, placebo-controlled study to investigate the safety, pharmacokinetics, tolerability, and efficacy of ALK-001 in Geographic Atrophy Secondary to age-related macular degeneration.

Hemera Biosciences HMR-2001

A phase 2 multi-center trial evaluating Intravitreal AAVCAGsCD59 compared to sham injection for the treatment of advanced dry age-related macular degeneration with geographic atrophy.

Hemera Biosciences HMR-1002

A Phase 1, multi-center, open label study to assess the efficacy and safety of a single dose of the adeno-associated viral vector serotype 2 (AAVCAGsCD59) expressing sCD59 administered via intravitreal injection seven days after a single intravitreal injection of anti-VEGF. All patients considered for enrollment in this study must have treatment naive wet AMD.

Kodiak Sciences Inc KSI-CL-102 DAZZLE

A phase 2b/3, 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.

Kodiak Sciences Inc KSI-301-P104 GLEAM

Phase 3, prospective, randomized, double-masked, active comparator-controlled, multi-center, two-arm, 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.

Kodiak Sciences DAZZLE

A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration.

Diabetic Retinopathy Clinical Research PROTOCOL AA 

Peripheral Diabetic Retinopathy (DR) Lesions on Ultrawide-field Fundus Images and Risk of DR Worsening Over Time.

Diabetic Retinopathy Clinical Research Network Protocol AG

Randomized clinical trial assessing the effects of pneumatic Vitreolysis on vitreomacular traction

Diabetic Retinopathy Clinical Research Network PROTOCOL S

A Phase III, multi-center randomized clinical trial, prompt Panretinal Photocoagulation verses Intravitreal Ranibizumab with Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy.

Allergan DARPin Sequoia Trial

This is a multicenter, double-masked, randomized, 100-week, parallel-group, activecontrolled study to evaluate the safety and efficacy of abicipar in treatment-naïve patients with neovascular AMD.

University of Virginia TOGA

A randomized, double masked, placebo controlled study evaluating ORACEA (subantimicrobial doxycycline) in subjects with geographic atrophy secondary to non-exudative age-related macular degeneration.

Genentech Avenue Trial

The study will allow evaluation of RO6867461 in a treatment-naive patient population (comparison of Arms A, B, C, and D) and an anti-VEGF−incomplete-responder patient population that meets a predefined criterion at Week 12 (comparison between Arms A and E).CNV component area of . 50% of total lesion size by FFA.

Genentech Boulevard Trial Study #: BP30099

A Multiple-Center, Multiple-Dose, Randomized, Active Comparator-Controlled, Double-Masked, Parallel Group, 28-Week Study To Investigate The Safety, Tolerability, Pharmacokinetics, And Efficacy Of RO6867461 Administered Intravitreally In Patients With Diabetic Macular Edema.

Genentech HARBOR TRIAL
Protocol # FVF4579g

A Phase III, Double-Masked, Multicenter, Randomized, Active Treatment-Controlled Study Of The Efficacy And Safety Of 0.5 mg And 2.0 mg Ranibizumab Administered Monthly Or On An As-Needed Basis (PRN) In Patients with Subfoveal Neovascular Age-Related Macular Degeneration.

Genentech HARBOR TRIAL
Protocol # FVF4579g

A Phase III, Double-Masked, Multicenter, Randomized, Active Treatment-Controlled Study Of The Efficacy And Safety Of 0.5 mg And 2.0 mg Ranibizumab Administered Monthly Or On An As-Needed Basis (PRN) In Patients with Subfoveal Neovascular Age-Related Macular Degeneration.

Genentech SHORE TRIAL
Protocol # FVF4967g

A Phase IV Multicenter Randomized Study Evaluating Dosing Regimens for Treatment with intravitreal Ranibizumab injections in Subjects with macular edema following Retinal Vein Occlusion.

Regeneron RE-VIEW TRIAL
Protocol # VGFTe-AMD-1124

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.

Diabetic Retinopathy Clinical Research Network PROTOCOL T

A randomized, multi-center clinical trial for a comparative Effectiveness of Intravitreal Aflibercept, Bevacizumab and Ranibizumab for Diabetic Macular Edema.

Genentech Ladder Trial

The primary efficacy objective for this study is as follows: To evaluate the relative efficacy of 10-mg/mL, 40-mg/mL, and 100-mg/mL formulations of ranibizumab, delivered via the Implant, RANIBIZUMAB PORT DELIVERY SYSTEM, as measured by the time a patient first requires Implant refill according to protocol-defined refill criteria compared with the control arm (0.5-mg monthly ITV injections of 10-mg/mL formulation) in patients with subfoveal neovascular (wet) age-related macular degeneration (AMD).

Ophthotech REGRESS TRIAL
Protocol# OPH1001A

A Phase 2, 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.

Ophthotech Eclipse Trial
Protocol# OPH1003

A Phase 3 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 Insubjects With Subfoveal Neovascular Age-Related Macular Degeneration.

Ophthotech 1004 Trial

A phase III randomized, double-masked, controlled trial to establish the safety and efficacy of intravitreous administration of Fovista administered in combination with either Avastin or Eylea monotherapy in subjects with subfoveal neovascular age-related macular degeneration.

Ophthotech 1006 Trial

Subjects will be treated with “Combination Therapy” of IVT Fovista and IVT Anti-VEGF therapy.

Diabetic Retinopathy Clinical Research Network Protocol V

For Treatment for Central-Involved Diabetic Macular Edema in Eyes With Very Good Visual Acuity.

Eyegate Macular Edema

To evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution, EGP-437, using the EyeGate® II Drug Delivery System (EGDS) in patients with macular edema (ME) Study subjects will receive 40 mg/mL dexamethasone phosphate solution delivered via transcleral iontophoresis at 14.0 mA-min at 3.5 mA on Day 0, Day 4, and Day 9.

Kodiak Sciences Inc KSI-301-P103 BEACON

Phase 3, prospective, randomized, double-masked, active comparator-controlled, multi-center, two-arm, study to evaluate the efficacy and safety of intravitreal KSI-301 compared with intravitreal Aflibercept in participants with visual impairment secondary to treatment-naïve macular edema secondary to retinal vein occlusion.

IVERIC Biosciences ISEE2008/Gather

A phase 3 multi-center, randomized, double masked, sham-controlled clinical trial to access the safety and efficacy of intravitreal administration of Zimura (complement C5 inhibitor) in patients with geographic atrophy secondary to age-related macular degeneration.

Genentech RHONE-X GR41987

A multi-center, open label extension study to evaluate the long term safety and tolerability of Faricimab in patients with diabetic macular edema. GR41987 is a study for people who previously participated in and completed either Study GR40349 (also known as YOSEMITE) or GR40398 (also known as RHINE) (also referred to as the parent studies).