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出境医 / 临床实验 / A Study Assessing the Safety, Tolerability, and Efficacy of RG6147 in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD) (GALLEGO)

A Study Assessing the Safety, Tolerability, and Efficacy of RG6147 in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD) (GALLEGO)

Study Description
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 open-label extension study NCT03972709 (GR42558) and receive open-label RG6147 injections.

Condition or disease Intervention/treatment Phase
Macular Degeneration, Age-Related Geographic Atrophy Drug: RG6147 Drug: Sham Control Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : June 3, 2024
Estimated Study Completion Date : June 3, 2024
Arms and Interventions
Arm Intervention/treatment
Experimental: RG6147 Q4W
Participants will receive RG6147 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 NCT03972709 (GR42558) and receive open-label RG6147 injections.
 Drug: RG6147
Intravitreal (ITV) injections of 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 NCT03972709 (GR42558) and receive open-label RG6147 injections.
 Drug: Sham Control
ITV injections of Sham Control
Experimental: RG6147 Q8W
Participants will receive RG6147 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 NCT03972709 (GR42558) and receive open-label RG6147 injections.
 Drug: RG6147
Intravitreal (ITV) injections of 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 NCT03972709 (GR42558) and receive open-label RG6147 injections.
 Drug: Sham Control
ITV injections of Sham Control
Outcome Measures
Primary Outcome Measures :
  1. Change From Baseline in GA Area as Measured by Fundus Autofluorescence (FAF) at Week 72 [ 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 ]

Eligibility Criteria
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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

Contacts
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Contact: Reference Study ID Number: GR40973 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Locations
Show Show 80 study locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
Tracking Information
First Submitted Date  ICMJE May 31, 2019
First Posted Date  ICMJE June 4, 2019
Last Update Posted Date May 20, 2021
Actual Study Start Date  ICMJE June 3, 2019
Estimated Primary Completion Date June 3, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2019) 		Change From Baseline in GA Area as Measured by Fundus Autofluorescence (FAF) at Week 72 [ Time Frame: Baseline, Week 72 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2020)
  • Percentage of Participants With Ocular Adverse Events [ Time Frame: From baseline to Week 76 ]
  • Percentage of Participants With Systemic Adverse Events [ Time Frame: From baseline to Week 76 ]
  • Percentage of Participants With Serious Adverse Events (SAEs) [ Time Frame: From baseline to Week 76 ]
  • Percentage of Participants With Adverse Events of Special Interest (AESIs) [ Time Frame: From baseline to Week 76 ]
  • Percentage of Participants With Adverse Events Leading to Study Discontinuation [ Time Frame: From baseline to Week 76 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
  • Percentage of Participants With Ocular Adverse Events [ Time Frame: From baseline to Week 76 ]
  • Percentage of Participants With Systemic Adverse Events [ Time Frame: From baseline to Week 76 ]
  • Percentage of Participants With Serious Adverse Events (SAEs) [ Time Frame: From baseline to Week 76 ]
  • Percentage of Participants With Adverse Events of Special Interest (AESIs) [ Time Frame: From baseline to Week 76 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Assessing the Safety, Tolerability, and Efficacy of RG6147 in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)
Official Title  ICMJE 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)
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 open-label extension study NCT03972709 (GR42558) and receive open-label RG6147 injections.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Macular Degeneration, Age-Related
  • Geographic Atrophy
Intervention  ICMJE
  • Drug: RG6147
    Intravitreal (ITV) injections of RG6147
  • Drug: Sham Control
    ITV injections of Sham Control
Study Arms  ICMJE
  • Experimental: RG6147 Q4W
    Participants will receive RG6147 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 NCT03972709 (GR42558) and receive open-label RG6147 injections.
    Intervention: Drug: 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 NCT03972709 (GR42558) and receive open-label RG6147 injections.
    Intervention: Drug: Sham Control
  • Experimental: RG6147 Q8W
    Participants will receive RG6147 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 NCT03972709 (GR42558) and receive open-label RG6147 injections.
    Intervention: Drug: 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 NCT03972709 (GR42558) and receive open-label RG6147 injections.
    Intervention: Drug: Sham Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 6, 2020) 		360
Original Estimated Enrollment  ICMJE
 (submitted: May 31, 2019) 		285
Estimated Study Completion Date  ICMJE June 3, 2024
Estimated Primary Completion Date June 3, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Reference Study ID Number: GR40973 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03972709
Other Study ID Numbers  ICMJE GR40973
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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).
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Genentech, Inc.
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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