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A Study Assessing the Safety, Tolerability, and Efficacy of 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 : Active, not recruiting
First Posted : June 4, 2019
Last Update Posted : September 14, 2022
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE May 31, 2019
First Posted Date  ICMJE June 4, 2019
Last Update Posted Date September 14, 2022
Actual Study Start Date  ICMJE June 3, 2019
Estimated Primary Completion Date December 15, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2021)
Mean Change in GA Area from Baseline to Week 72 as Measured by Fundus Autofluorescence (FAF) [ Time Frame: Baseline, Week 72 ]
Original 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2021)
  • 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 ]
  • 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 ]
  • Mean Change in BCVA Score from Baseline to Week 72 as Assessed by ETDRS Chart [ Time Frame: Baseline, Week 72 ]
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 FHTR2163 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 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 NCT03972709 (GR42558) and receive open-label FHTR2163 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: FHTR2163
    Intravitreal (ITV) injections of FHTR2163
    Other Name: RG6147
  • Drug: Sham Control
    ITV injections of Sham Control
Study Arms  ICMJE
  • Experimental: FHTR2163 Q4W
    Participants will receive FHTR2163 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 FHTR2163 injections.
    Intervention: Drug: FHTR2163
  • 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 FHTR2163 injections.
    Intervention: Drug: Sham Control
  • Experimental: FHTR2163 Q8W
    Participants will receive FHTR2163 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 FHTR2163 injections.
    Intervention: Drug: FHTR2163
  • 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 FHTR2163 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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 6, 2020)
360
Original Estimated Enrollment  ICMJE
 (submitted: May 31, 2019)
285
Estimated Study Completion Date  ICMJE December 15, 2023
Estimated Primary Completion Date December 15, 2023   (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 information is only displayed when the study is recruiting subjects
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).
Current Responsible Party Genentech, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Genentech, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Genentech, Inc.
Verification Date September 2022

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