Summary

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

Description

Summary

This study will evaluate the safety, tolerability, and efficacy of intravitreal injections of RO7171009 administered every 4 weeks (Q4W) or every 8 weeks (Q8W) for approximately 76 weeks in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) compared with sham control.

Official Title

A Phase II, Multicenter, Randomized, Single-Masked, Sham-Controlled Study to Assess Safety, Tolerability, and Efficacy of Intravitreal Injections of FHTR2163 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration (GALLEGO)

Keywords

Macular Degeneration, Age-Related Geographic Atrophy Macular Degeneration Atrophy

Eligibility

You can join if…

Open to people ages 60 years and up

  • Age >/= 60 years at time of signing Informed Consent Form;
  • Visual acuity: best-corrected visual acuity (BCVA) letter score >/= 24 letters (Snellen equivalent of 20/320 or better);
  • Well-demarcated area of GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in either eye.

You CAN'T join if...

Ocular Exclusion Criteria, Study Eye:

  • History of vitrectomy surgery, submacular surgery, or any surgical intervention for AMD;
  • Previous laser photocoagulation or ITV anti-vascular endothelial growth factor (anti-VEGF) for CNV, diabetic macular edema, retinal vein occlusion, or proliferative diabetic retinopathy.

Ocular Exclusion Criteria, Both Eyes:

  • GA in either eye due to causes other than AMD;
  • Active uveitis and/or vitritis (grade trace or above) in either eye;
  • Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye;
  • Retinal pigment epithelium (RPE) tear that involves the macula in either eye;
  • Previous participation in interventional clinical trials for GA or dry AMD, except for vitamins and minerals, regardless of the route of administration (i.e., ocular or systemic) within the last 6 months.

Locations

  • Jules Stein Eye Institute/ UCLA accepting new patients
    Los Angeles California 90095-7000 United States
  • Retina-Vitreous Associates Medical Group accepting new 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 accepting new patients
    Encino California 91436 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Genentech, Inc.
ID
NCT03972709
Phase
Phase 2
Study Type
Interventional
Last Updated