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Trial record 1 of 133 for:    gallego
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A Study Assessing the Safety, Tolerability, and Efficacy of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD) (GALLEGO)

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: NCT03972709
Recruitment Status : Terminated (The benefit to risk balance did not support further treatment with galegenimab (FHTR2163).)
First Posted : June 4, 2019
Last Update Posted : April 4, 2023
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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Brief Summary:
This study will evaluate the safety, tolerability, and efficacy of intravitreal injections of galegenimab (FHTR2163) 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 open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab (FHTR2163) injections.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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)
Actual Study Start Date : June 3, 2019
Actual Primary Completion Date : October 27, 2022
Actual Study Completion Date : October 27, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Galegenimab Q4W
Participants will receive galegenimab every 4 weeks (Q4W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
 Drug: Galegenimab
Intravitreal (ITV) injections of galegenimab
Other Name: FHTR2163, RG6147
Sham Comparator: Sham Control Q4W
Participants will receive Sham-control Q4W. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
 Drug: Sham Control
Sham control
Experimental: Galegenimab Q8W
Participants will receive galegenimab every 8 weeks (Q8W). After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
 Drug: Galegenimab
Intravitreal (ITV) injections of galegenimab
Other Name: FHTR2163, RG6147
Sham Comparator: Sham Control Q8W
Participants will receive Sham-control Q8W. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab injections.
 Drug: Sham Control
Sham control


Outcome Measures
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Primary Outcome Measures :
  1. Mean Change in GA Area from Baseline to Week 72 as Measured by Fundus Autofluorescence (FAF) [ Time Frame: Baseline, Week 72 ]

Secondary Outcome Measures :
  1. Percentage of Participants With Ocular Adverse Events [ Time Frame: From baseline to Week 76 ]
  2. Percentage of Participants With Systemic Adverse Events [ Time Frame: From baseline to Week 76 ]
  3. Percentage of Participants With Serious Adverse Events (SAEs) [ Time Frame: From baseline to Week 76 ]
  4. Percentage of Participants With Adverse Events of Special Interest (AESIs) [ Time Frame: From baseline to Week 76 ]
  5. Percentage of Participants With Adverse Events Leading to Study Discontinuation [ Time Frame: From baseline to Week 76 ]
  6. 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 [ Time Frame: Baseline, Week 72 ]
  7. Mean Change in BCVA Score from Baseline to Week 72 as Assessed by ETDRS Chart [ Time Frame: Baseline, Week 72 ]

Eligibility Criteria
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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:

  • 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). If the study eye 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);
  • Well-demarcated area of GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in either eye.

Exclusion Criteria:

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.
Contacts and Locations
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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): NCT03972709


Locations
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Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT03972709    
Other Study ID Numbers: GR40973
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: April 4, 2023
Last Verified: March 2023
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).

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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