FHTR2163 for Geographic Atrophy

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Geographic Atrophy+3 More
FHTR2163 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study a new drug for age-related macular degeneration given either every 4 weeks or 8 weeks. The goal is to see if it is safe and effective compared to a sham control. Participants will have the option to continue in an extension study after the trial is complete.

Eligible Conditions
  • Geographic Atrophy
  • Age - Related Macular Degeneration (AMD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Geographic Atrophy

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: From baseline to Week 76

Baseline, Week 72
Change From Baseline in GA Area as Measured by Fundus Autofluorescence (FAF) at Week 72
Mean Change in BCVA Score from Baseline to Week 72 as Assessed by ETDRS Chart
Mean Change in Best Corrected Visual Acuity (BCVA) Score from Baseline to Week 72 as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart Under Low-luminance Conditions
Mean Change in GA Area from Baseline to Week 72 as Measured by Fundus Autofluorescence (FAF)
Week 76
Percentage of Participants With Adverse Events Leading to Study Discontinuation
Percentage of Participants With Adverse Events of Special Interest (AESIs)
Percentage of Participants With Ocular Adverse Events
Percentage of Participants With Serious Adverse Events (SAEs)
Percentage of Participants With Systemic Adverse Events

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Geographic Atrophy

Trial Design

6 Treatment Groups

FHTR2163 Q8W
1 of 6
FHTR2163 Q4W
1 of 6
RG6147 Q4W
1 of 6
RG6147 Q8W
1 of 6
Sham Control Q4W
1 of 6
Sham Control Q8W
1 of 6
Experimental Treatment
Non-Treatment Group

360 Total Participants · 6 Treatment Groups

Primary Treatment: FHTR2163 · Has Placebo Group · Phase 2

FHTR2163 Q8W
Drug
Experimental Group · 1 Intervention: FHTR2163 · Intervention Types: Drug
FHTR2163 Q4W
Drug
Experimental Group · 1 Intervention: FHTR2163 · Intervention Types: Drug
RG6147 Q4W
Drug
Experimental Group · 1 Intervention: RG6147 · Intervention Types: Drug
RG6147 Q8W
Drug
Experimental Group · 1 Intervention: RG6147 · Intervention Types: Drug
Sham Control Q4W
Drug
ShamComparator Group · 1 Intervention: Sham Control · Intervention Types: Drug
Sham Control Q8W
Drug
ShamComparator Group · 1 Intervention: Sham Control · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline to week 76

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor
1,486 Previous Clinical Trials
563,559 Total Patients Enrolled
7 Trials studying Geographic Atrophy
830 Patients Enrolled for Geographic Atrophy
Clinical TrialsStudy DirectorHoffmann-La Roche
2,131 Previous Clinical Trials
901,306 Total Patients Enrolled
11 Trials studying Geographic Atrophy
4,349 Patients Enrolled for Geographic Atrophy

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The patient has AMD in a well-defined area and there is no evidence of prior or active CNV in either eye.
The person must be at least 60 years old when they sign the Informed Consent Form.
A participant has excellent vision if their best-corrected visual acuity (BCVA) letter score is 24 letters or better (Snellen equivalent of 20/320 or better)

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 10th, 2021

Last Reviewed: October 21st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Florida100.0%
How old are they?
65+100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%