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Genentech GAllego Study - Geographic Atrophy AMD

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

Study Description:

Condition or Disease

Intervention / Treatment

Phase

Sponsor

Status

Geographic Atrophy

RG6147

Other: Sham

Phase 2

Genentech

Currently Enrolling

 

Brief Summary:

This study will evaluate the safety, tolerability, and efficacy of intravitreal injections of RG6147 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. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in an open-label extension study (GR42558) and receive open-label RG6147 injections. 

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Contacts:
Beachwood Office - Diane Weiss, RN  216-381-5700     •    dew@retina-assoc.com
Middleburg Heights Office - Susan Rath  440-663-0022    •    srath@retina-assoc.com
Youngstown Office - John Lacombe  330-759-8777    •    jlacombe@retina-assoc.com

For More Information:
https://clinicaltrials.gov/ct2/show/NCT03972709