Clinical Trials

Geographic Atrophy (GA)

CUREOS IONIS Clinical Trial (Actively Recruiting Participants)

IONIS (Recruiting)

IONIS-LB-LRx inhibits system factor B (FB), an inflammatory mediator linked to GA progression. IONIS-LB-LRx is given as a subcutaneous injection. This study compares IONIS-LB-LRx to placebo in participants with GA over 24-months.

Study locations:
Sydney Retina Clinic, Strathfield Retina Clinic

Additional study information for participants and health professionals

For Participants:

This study will evaluate safety and efficacy of IONIS-FB-LRx on the rate of change in geographic atrophy (GA) area compared to placebo treatment. IONIS-FB-LRx or placebo is administered subcutaneously (via stomach or thigh) every 4 weeks, until end of treatment at week 52. Stage 1 participants will be randomised to 1 of 3 dose levels.

For Health Professionals:

This phase 2 study will evaluate the effect of IONIS-FB-LRx on the rate of change of the area of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) measured by fundus autofluorescence (FAF). IONIS-FB-LRx will be evaluated against placebo treatment, administered subcutaneously every 4 weeks until week 52.

  • Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal.
  • Vaccination against Neisseria meningitidis and Streptococcus pneumoniae received at least 2 weeks prior to first dose of investigational product
  • Well-demarcated geographic atrophy (GA) due to AMD
  • Best-corrected visual acuity (BCVA) letter score of 35 letters (approx. 20/200 Snellen equivalent) or better.
  • Must have clear ocular media and adequate pupillary dilation in the study eye to permit high-quality fundus imaging
  • Clinically-significant abnormalities in medical history
  • A lack of full recovery from any infection for at least 14 days prior to the Study Drug administration
  • Chronic treatment with steroids, including topically or intravitreally administered
  • History or presence of diabetic retinopathy or diabetic macular edema (DME)
  • History or presence of a disease other than AMD that could affect vision or safety assessments
  • Prior treatment with another investigational drug, biological agent, or device
*Additional inclusion & exclusion criteria may apply

JNJ-81201887 is a gene therapy treatment designed to block the complement inflammatory pathway linked to GA progression via the regulatory protein CD59. JNJ-81201887 is given as a single intravitreal injection into the eye and will be compared to a placebo/sham injection. Participants will be monitored over 18 months.

Study locations:
Sydney Retina Clinic

This is an observational study investigating the natural course of intermediate AMD. There is no treatment or intervention involved. Participants will be closely monitored over a 3-year period.

Study locations:
Sydney Retina Clinic

This is an observational study investigating the natural course of GA. There is no treatment or intervention involved. Data from participants will collected at baseline and at a secondary visit after 12-18 months.

Study locations:
Sydney Retina Clinic

Zimura is a complement C5 inhibitor given as an intravitreal injection into the eye. Zimura is currently being compared to a sham injection over 24 months.

Pegcetacoplan (APL-2) targets C3 and helps regulate the complement pathway to reduce GA progression. Pegcetacoplan is given as an intravitreal injection into the eye. This is an open label extension study evaluating long term safety of pegcetacoplan in patients with GA. Patients will receive pegcetacoplan monthly for 24 months.

ANX007 inhibits the classic complement cascade. ANX007 is given as an intravitreal injection into the eye. ANX007 is being compared to a sham injection over 12 months. Participants will receive ANX007 every month (EM) or every other month (EOM).

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