Summary

Eligibility
for people ages 60 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

The purpose of this study is to evaluate the long-term safety and tolerability of intravitreal (ITV) injections of RG6147 administered every 4 weeks (Q4W) or every 8 weeks (Q8W) in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) who completed the parent study (NCT03972709/GR40973).

Official Title

A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intravitreal Injections of FHTR2163 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Keywords

Macular Degeneration, Age-Related Geographic Atrophy Macular Degeneration Atrophy

Eligibility

You can join if…

Open to people ages 60 years and up

  • Completed the parent study (NCT03972709/GR40973) through the Week 76 visit without early treatment discontinuation
  • Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit acceptable fundus imaging.

Ocular Inclusion Criteria: Study Eye - If the study eye best corrected visual acuity (BCVA) letter score is ≥69 letters (Snellen equivalent of 20/40 or better), the non-study eye must have a BCVA letter score of ≥44 letters (Snellen equivalent of 20/125 or better) on visit Day 1 of the open label extension (OLE)/Week 76 of parent study.

Ocular Inclusion Criteria: Non-Study Eye

  • The non-study eye must have a BCVA letter score of ≥44 letters (Snellen equivalent of 20/125 or better) if the study eye BCVA letter score is ≥69 letters (Snellen equivalent of 20/40 or better) on visit Day 1 OLE/Week 76 of parent study.

You CAN'T join if...

Ocular Exclusion Criteria:

  • Active uveitis and/or vitritis (grade trace or above) in either eye
  • Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
  • Active or history of choroidal neovascularization (CNV) in study eye that requires anti-vascular endothelial growth factor (anti-VEGF) treatment
  • Active or recent history (i.e., since enrollment in parent study) of optic neuritis in either eye
  • Retinal pigment epithelium (RPE) tear that involves the macula in either eye
  • Moderate or severe non-proliferative diabetic retinopathy in either eye
  • Proliferative diabetic retinopathy in either eye
  • Central serous retinopathy in either eye
  • Recent history of recurrent infectious or inflammatory ocular disease in either eye
  • Recent history of idiopathic or autoimmune-associated uveitis in either eye
  • Any concurrent ocular or intraocular condition in the study eye that contraindicates the use of an investigational drug or may affect interpretation of the study results or may render the participant at high risk for treatment complications

Locations

  • Jules Stein Eye Institute/ UCLA not yet accepting patients
    Los Angeles California 90095-7000 United States
  • Retina-Vitreous Associates Medical Group not yet accepting patients
    Beverly Hills California 90211 United States
  • W Coast Retina Med Group Inc accepting new patients
    San Francisco California 94107 United States
  • The Retina Partners in progress, not accepting new patients
    Encino California 91436 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Genentech, Inc.
ID
NCT04607148
Phase
Phase 2
Study Type
Interventional
Last Updated