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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04607148
Recruitment Status : Active, not recruiting
First Posted : October 29, 2020
Last Update Posted : September 14, 2022
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

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).

Condition or disease Intervention/treatment Phase
Macular Degeneration, Age-Related Geographic Atrophy Drug: FHTR2163 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: The study will be masked until database lock of the parent study (NCT03972709/GR40973). After the masked period, the study will follow an open-label design.
Primary Purpose: Treatment
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
Actual Study Start Date : November 16, 2020
Estimated Primary Completion Date : December 19, 2025
Estimated Study Completion Date : December 19, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FHTR2163 20 mg Q4W
Participants will receive 20 milligrams (mg) FHTR2163 via ITV injection every 4 weeks (Q4W).
Drug: FHTR2163
Intravitreal (ITV) injections of FHTR2163

Experimental: FHTR2163 20 mg Q8W
Participants will receive 20 mg FHTR2163 via ITV injection every 8 weeks (Q8W).
Drug: FHTR2163
Intravitreal (ITV) injections of FHTR2163

Experimental: FHTR2163 10 mg Q4W
Participants will receive 10 mg FHTR2163 via ITV injection Q4W.
Drug: FHTR2163
Intravitreal (ITV) injections of FHTR2163

Experimental: FHTR2163 10 mg Q8W
Participants will receive 10 mg FHTR2163 via ITV injection Q8W.
Drug: FHTR2163
Intravitreal (ITV) injections of FHTR2163




Primary Outcome Measures :
  1. Percentage of Participants With Ocular Adverse Events by Severity [ Time Frame: Up to Week 148 ]
  2. Percentage of Participants With Systemic (Non-Ocular) Adverse Events by Severity [ Time Frame: Up to Week 148 ]

Secondary Outcome Measures :
  1. Serum Concentration of FHTR2163 [ Time Frame: Day 1, Weeks 24, 48, 72, 96, 144, unscheduled visit (UV) or early termination (ET) visit (up to Week 148) ]
  2. Aqueous Humor Concentration of FHTR2163 [ Time Frame: Day 1, Weeks 24, 48, 72, 96, 144 and UV (up to Week 148) ]
  3. Percentage of Participants With Anti-Drug Antibodies to FHTR2163 [ Time Frame: Day 1, Weeks 24, 48, 72, 96, 144, UV or ET visit (up to Week 148) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04607148


Locations
Show Show 52 study locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT04607148    
Other Study ID Numbers: GR42558
First Posted: October 29, 2020    Key Record Dates
Last Update Posted: September 14, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Degeneration
Geographic Atrophy
Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical