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A Study Assessing the Long-Term Safety and Tolerability of FHTR2163 in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

About

Brief Summary

The purpose of this study is to evaluate the long-term safety and tolerability of intravitreal (ITV) injections of FHTR2163 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).

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 2

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
60 Years
Maximum Age
N/A

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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.

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Study Stats
Protocol No.
21-000544
Category
Ophthalmology
Contact
Naomi Long
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04607148
For detailed technical eligibility, visit ClinicalTrials.gov.