Current Trials

ALXN2040

ALEXION PHARMACEUTICALS

A Phase 2, Double-Masked, Placebo-Controlled, Dose Range Finding Study of Danicopan (ALXN2040) in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

NIH registration: Clinialtrials.gov

Status: Upcoming

Summary: The study will test danicopan, a new oral drug that is being developed by Alexion to slow down progression of GA in dry AMD. Danicopan is a small molecule complement FD inhibitor that can be administered orally. Based on data from studies done oral danicopan is able to cross the blood‑retina barrier. Therefore, the drug can reach the eye tissues where it is needed. It is believed/hypothesized, that danicopan could slow the worsening of GA and prevent vision loss.

RGX-314-3101

REGENXBIO INC.

A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants with nAMD

NIH registration: Pending

Status: Upcoming

Summary: The purpose of this study is to evaluate whether two different doses of RGX-314 help improve or preserve vision compared to Eylea for wet AMD. In this study, you will either receive RGX-314 or Eylea. If you are assigned to receive RGX-314, you will either receive the low dose or the high dose of RGX-314 that are being evaluated in this study eye.  RGX-314 is being studied for its potential to have one single injection that could allow the eye to make its own supply of anti-VEGF continually. Only one eye (your study eye) will receive RGX-314. This will be performed at a hospital or surgical center via local and monitored anesthesia. Once cells receive this gene, it is expected that the cells may be able to make their own anti-VEGF. This may decrease your need for future treatment for wet AMD and help stop further vision loss.

GOLDEN

IONIS PHARMACEUTICALS INC.

A Phase 2, Randomized, Placebo-Controlled, Double-Masked Study to Assess Safety and Efficacy of Multiple Doses of IONIS-FB-LRX, an Antisense Inhibitor of Complement Factor B, in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)

NIH registrationClinicaltrials.gov

Status: Enrolling

Summary: The study drug is designed to slow the body’s production of the protein called Factor B (FB) that is made in the liver and found in the eye which may contribute to GA secondary to AMD. This study will also compare the study drug with placebo (an inactive substance that contains no medicine). The purpose of this study is to see if the study drug given systemically, reduces the amount of FB and if this will slow the progression of GA in persons who have AMD. We measure the amount of FB by checking blood and measure GA by taking images of your eyes. Also, we want to determine safety and tolerability of the study drug. We want to learn what effects (good or bad) several different doses of the study drug has on GA secondary to AMD subjects 50 years or older. 

TRS4VISION

TARSIER PHARMA LTD.

A Phase 3 Randomized, Active-Controlled, Double-Masked Study to Evaluate the Safety and Efficacy of TRS01 Eye Drops in the Treatment of Subjects with Active Non-infectious Anterior Uveitis including Subjects with Uveitic Glaucoma

NIH registrationClinicaltrials.gov

Status: Enrolling

Summary: The safety and efficacy of TRS01 eye drops will be evaluated and compared to standard of care steroid eye drops. Participation is limited to subjects 70 years of age or younger who have active non-infectious anterior uveitis and are currently without treatment or on a stable dose of their current treatment. Subjects will be followed for 6 weeks over the course of 6 office visits.

 

2017054

AMGEN INC.

A Phase III Randomized Double -Masked Study of ABP 938 Efficacy and Safety Compared to Aflibercept in subjects with Neovascular Age related Macular Degeneration

NIH registrationClinicaltrials.gov

Status: Active, enrollment closed

Summary: The purpose of this study is to compare the efficacy and safety of ABP 938 versus Aflibercept (Eylea®) in the treatment of neovascular age-related macular degeneration. Subjects will be randomized in a masked 1:1 ratio to receive 2 mg (0.05 mL) of either ABP 938 (Treatment Group A) or aflibercept (Treatment Group B) administered by intravitreal (IVT) injection.

DAZZLE

KODIAK SCIENCES INC.
A Phase III 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
NIH registrationClinicaltrials.gov

Status: Active, enrollment closed

Summary: This study will evaluate the efficacy, safety, durability, and pharmacokinetics of KSI-301 administered at 12, 16 and 20 weeks intervals as specified in the protocol, compared with aflibercept once every 8 weeks, in participants with treatment-naïve neovascular (wet) age-related macular degeneration.

GALE

APELLIS PHARMACEUTICALS INC.

A Phase 3 Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegcetacoplan in Subjects with Geographic Atrophy Secondary to Age-Related Macular Degeneration

NIH registration: Clinicaltrials.gov

Status: Active, enrollment closed

Summary: This is a phase 3, open-label, multicenter, extension study to evaluate the long-term safety and efficacy of pegcetacoplan (APL-2) in subjects with geographic atrophy secondary to age-related macular degeneration who completed the treatment at Month 24 of the Oaks study.

 

GATHER2/ISEE2008

IVERIC BIO

A Phase 3 Multicenter, Randomized Double-Masked, Sham-Controlled Clinical Trial to Assess the Safety and Efficacy of Intravitreal Administration of Zimura™ (Complement C5 Inhibitor) in Subjects with Geographic Atrophy Secondary to Age-Related Macular Degeneration

NIH registration: Clinicaltrials.gov

Status: Active, enrollment closed

Summary: The objectives of this study are to evaluate the effectiveness and safety of Zimura intravitreous administration compared to sham when administered in research participants with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).

 

PORTAL

GENENTECH/F. HOFFMANN-LA ROCHE LTD.

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

NIH registrationClinicaltrials.gov

Status: Active, enrollment closed

Summary: The purpose of this study is to find out the long-term effects, good or bad, of the ocular (eye) implant on you and your wet AMD when it delivers a dose of ranibizumab.  The ocular implant releases ranibizumab continuously (without stopping) for a long period of time into the back of your eye, and it can be refilled by your study doctor.  Because the implant releases ranibizumab over time, you may not need treatment as often. The implant is intended to remain life-long in the eye, unless removed for medical reasons. Wet AMD is an advanced form of AMD that can cause rapid and severe vision loss.  A growth factor called vascular endothelial growth factor (VEGF) is thought to be involved in the formation and leakiness of abnormal blood vessels, which leak blood or fluid in the macula (the central part of the retina responsible for sharp detailed central vision) and form scars that cause central vision to get worse and may result in permanent blind spots in patients with wet AMD. Ranibizumab is a medicine that blocks the growth factor VEGF, which slows the growth of and leakage from the abnormal blood vessels in your eye.

PULSAR

BAYER AG / REGENERON PHARMACEUTICALS 

Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of High Dose Aflibercept in Patients With Neovascular Age-Related Macular Degeneration

NIH registrationClinicaltrials.gov

Status:  Active, enrollment closed

Summary: The current study will assess the effectiveness and safety of an investigational high dose of aflibercept (HD). The high dose is being studied to investigate whether an 8 mg dose of aflibercept can result in a longer time between injections and/or improved vision compared to current treatment with 2 mg aflibercept.