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出境医 / 临床实验 / A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD (ALTISSIMO)

A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD (ALTISSIMO)

Study Description
Brief Summary:
Phase 2b, multicenter, visual examiner-masked, randomized active-controlled, parallel-arm design study to evaluate the safety and duration of repeated IVT injections of 3 dose levels of GB-102 compared with aflibercept.

Condition or disease Intervention/treatment Phase
Neovascular Age-Related Macular Degeneration Drug: Drug: GB-102 Drug: Aflibercept Phase 2

Detailed Description:

Phase 2b, multicenter, visual examiner-masked, randomized active-controlled, parallel-arm design study to evaluate the safety and duration of the effect of GB-102, as measured by time to first rescue treatment across multiple dose levels of GB-102 administered every 6 months as compared to intravitreal (IVT) aflibercept administered every 2 months in subjects with neovascular (wet) age-related macular degeneration who have received prior induction with anti-vascular endothelial growth factor (VEGF)

Extension Study:

To monitor the safety and duration of effect of IVT GB-102 administered every 6 months compared to IVT aflibercept administered every 2 months in subjects in ALTISSIMO (Core Study) who complete all study visits through Month 12 (Day 360) and who do not require/receive rescue treatment at the Month 12 (Day 360) final study visit

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel-arm design
Masking: Single (Outcomes Assessor)
Masking Description: Visual examiner-masked
Primary Purpose: Treatment
Official Title: A Phase 2b Multicenter Dose-Ranging Study Evaluating the Safety and Efficacy of Sunitinib Malate Depot Formulation (GB-102) Compared to Aflibercept in Subjects With Neovascular (Wet) Age-related Macular Degeneration (ALTISSIMO Study)
Actual Study Start Date : September 26, 2019
Actual Primary Completion Date : December 15, 2020
Estimated Study Completion Date : June 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: GB-102 Dose 2 (1 mg)
Participants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
 Drug: Drug: GB-102
Intravitreal injection of GB-102
Other Name: Sunitinib malate
Experimental: GB-102 Dose 3 (2 mg)
Participants will receive intravitreal (IVT) GB-102 (2 mg) in the study eye at Baseline, intravitreal (IVT) GB-102 (1 mg) at Month 6 and sham at Months 2, 4, 8 and 10.
 Drug: Drug: GB-102
Intravitreal injection of GB-102
Other Name: Sunitinib malate
Active Comparator: Aflibercept 2 mg Dose
Participants will receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
 Drug: Aflibercept
Intravitreal injection of aflibercept (2 mg dose)
Other Name: Eylea
Outcome Measures
Primary Outcome Measures :
  1. Kaplan-Meier analysis of time to first rescue treatment [ Time Frame: Baseline through 12 months ]

Secondary Outcome Measures :
  1. Time to fulfillment of at least one rescue criterion [ Time Frame: 6 months through 12 months ]
    Assessment of time to fulfillment of at least one rescue criterion starting at the Month 6 visit through to the Month 12 visit

  2. Number of times that at least one rescue criterion is met [ Time Frame: Baseline through 12 months ]
    Assessment of the number of times that at least one rescue criterion is met

  3. Number of treatments, including both rescue and scheduled study treatments, during the study [ Time Frame: Baseline through 12 months ]
    Assessment of the number of treatments, including both rescue and scheduled study treatments, that occurred during the study

  4. Change from baseline in BCVA (ETDRS letter score) at all visits [ Time Frame: Baseline through 12 months ]

    BCVA = best corrected visual acuity; ETDRS = early treatment of diabetic retinopathy

    BCVA ETDRS range = 0 (worst) to 100 (best)

    Assessment of change in BCVA (ETDRS letter score) from baseline at all visits


  5. Categorical change from baseline in BCVA (ETDRS letter score) at all visits [ Time Frame: Baseline through 12 months ]

    BCVA = best corrected visual acuity; ETDRS = early treatment of diabetic retinopathy

    BCVA ETDRS range = 0 (worst) to 100 (best)

    Assessment of categorical change in BCVA (ETDRS letter score) from baseline at all visits


  6. Frequency of subjects with BCVA worse than 20/200 (Snellen equivalent) at all visits [ Time Frame: Baseline through 12 months ]

    Assessment of the frequency of subjects with BCVA worse than 20/200 (Snellen equivalent) at all visits

    A vision score of 20/20 is considered normal. A vision score of 20/200 is considered legally blind.


  7. Change from baseline in CST (μm) at all visits [ Time Frame: Baseline through 12 months ]

    CST = central subfield thickness

    Assessment of change in CST (μm) measurement from baseline at all visits


  8. Frequency of subjects with absence of exudation (intra-/sub-retinal fluid/cystoid edema) at at all visits [ Time Frame: Baseline through 12 months ]
    Assessment of the frequency of subjects with absence of exudation (intra-/sub-retinal fluid/cystoid edema) at all visits


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females ≥ 50 years of age
  • Presence of a CNV lesion secondary to AMD treated with at least 3 prior IVT injections of an anti-VEGF agent (aflibercept, bevacizumab, or ranibizumab).
  • Demonstrated response to prior anti-VEGF treatment since diagnosis
  • BCVA of 35 letters or better

Exclusion Criteria:

  • History, within 6 months prior to screening, of any of the following: myocardial infarction, any cardiac event requiring hospitalization, treatment for acute congestive heart failure, transient ischemic attack, or stroke
  • Uncontrolled hypertension, diabetes mellitus or IOP
  • Chronic renal disease
  • Abnormal liver function
  • Women who are pregnant or lactating
Contacts and Locations

Locations
Show Show 33 study locations
Sponsors and Collaborators
Graybug Vision
Investigators
Layout table for investigator information
Study Director: Chief Medical Officer Graybug Vision, Inc.
Tracking Information
First Submitted Date  ICMJE May 13, 2019
First Posted Date  ICMJE May 16, 2019
Last Update Posted Date May 11, 2021
Actual Study Start Date  ICMJE September 26, 2019
Actual Primary Completion Date December 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2021) 		Kaplan-Meier analysis of time to first rescue treatment [ Time Frame: Baseline through 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019) 		Kaplan-Meier analyses of the proportion of treated subjects remaining rescue-free through Month 10 [ Time Frame: Baseline through 10 months ]
Assessment of the percentage of subjects remaining rescue free at Month 10
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2021)
  • Time to fulfillment of at least one rescue criterion [ Time Frame: 6 months through 12 months ]
    Assessment of time to fulfillment of at least one rescue criterion starting at the Month 6 visit through to the Month 12 visit
  • Number of times that at least one rescue criterion is met [ Time Frame: Baseline through 12 months ]
    Assessment of the number of times that at least one rescue criterion is met
  • Number of treatments, including both rescue and scheduled study treatments, during the study [ Time Frame: Baseline through 12 months ]
    Assessment of the number of treatments, including both rescue and scheduled study treatments, that occurred during the study
  • Change from baseline in BCVA (ETDRS letter score) at all visits [ Time Frame: Baseline through 12 months ]
    BCVA = best corrected visual acuity; ETDRS = early treatment of diabetic retinopathy BCVA ETDRS range = 0 (worst) to 100 (best) Assessment of change in BCVA (ETDRS letter score) from baseline at all visits
  • Categorical change from baseline in BCVA (ETDRS letter score) at all visits [ Time Frame: Baseline through 12 months ]
    BCVA = best corrected visual acuity; ETDRS = early treatment of diabetic retinopathy BCVA ETDRS range = 0 (worst) to 100 (best) Assessment of categorical change in BCVA (ETDRS letter score) from baseline at all visits
  • Frequency of subjects with BCVA worse than 20/200 (Snellen equivalent) at all visits [ Time Frame: Baseline through 12 months ]
    Assessment of the frequency of subjects with BCVA worse than 20/200 (Snellen equivalent) at all visits A vision score of 20/20 is considered normal. A vision score of 20/200 is considered legally blind.
  • Change from baseline in CST (μm) at all visits [ Time Frame: Baseline through 12 months ]
    CST = central subfield thickness Assessment of change in CST (μm) measurement from baseline at all visits
  • Frequency of subjects with absence of exudation (intra-/sub-retinal fluid/cystoid edema) at at all visits [ Time Frame: Baseline through 12 months ]
    Assessment of the frequency of subjects with absence of exudation (intra-/sub-retinal fluid/cystoid edema) at all visits
Original Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • Mean change from baseline in best corrected visual acuity (BCVA) as assessed using the early treatment of diabetic retinopathy (ETDRS) protocol (range, 0 [worst] to 100 [best]) to the average BCVA ETDRS letter score at Months 9 and 10 [ Time Frame: Baseline through 10 months ]
    Assessment of change in BCVA from baseline compared to the average BCVA scores (ETDRS) at Months 9 and 10
  • Mean change from baseline in BCVA (ETDRS letter score) to all visits [ Time Frame: Baseline through 12 months ]
    BCVA = best corrected visual acuity; ETDRS = early treatment of diabetic retinopathy BCVA ETDRS range = 0 (worst) to 100 (best) Assessment of change in BCVA (ETDRS letter score) from baseline at all visits
  • Mean change from baseline in central subfield thickness (CST [μm]) to the average of Months 9 and 10 scores [ Time Frame: Baseline through 10 months ]
    Assessment of change in CST (μm) measurement from baseline compared to the average OCT CST (μm) measurements at Months 9 and 10
  • Mean change from baseline in CST (μm) at all visits [ Time Frame: Baseline through 12 months ]
    CST = central subfield thickness Assessment of change in CST (μm) measurement from baseline at all visits
  • Mean change from thickest observed CST (μm) prior to enrollment (pre-enrollment baseline) at all visits [ Time Frame: Screening through 12 months ]
    CST = central subfield thickness Assessment of change from thickest observed CST (μm) prior to enrollment (pre-enrollment baseline) compared to CST (μm) at all visits
  • Time to rescue treatment [ Time Frame: Baseline through 12 months ]
    Assessment of time to rescue treatment over 12 months of treatment
  • Mean number of intravitreal injections [ Time Frame: Baseline through 12 months ]
    Assessment of the mean number of intravitreal injections over 12 months of treatment
  • Proportion of subjects with absence of exudation (intra-/sub-retinal fluid/cystoid edema) at Months 9 and 12 of treatment [ Time Frame: Baseline through 12 months ]
    Assessment of the percentage of subjects with absence of exudation (intra-/sub-retinal fluid/cystoid edema) at Months 9 and 12 of treatment
  • Proportion of subjects who gained ≥ 15 ETDRS letters at Months 9 and 12 of treatment [ Time Frame: Baseline through 12 months ]
    ETDRS = early treatment of diabetic Assessment of the proportion of subjects who gained ≥ 15 ETDRS letters at Months 9 and 12 of treatment
  • Proportion of subjects who lost ≥ 15 ETDRS letters at Months 9 and 12 of treatment [ Time Frame: Baseline through 12 months ]
    ETDRS = early treatment of diabetic Assessment of the percentage of subjects who lost ≥ 15 ETDRS letters at Months 9 and 12 of treatment
  • Proportion of subjects with BCVA worse than 20/200 (Snellen equivalent) at Months 9 and 12 of treatment [ Time Frame: Baseline through 12 months ]
    Assessment of the percentage of subjects with BCVA worse than 20/200 (Snellen equivalent) at Months 9 and 12 of treatment A vision score of 20/20 is considered normal. A vision score of 20/200 is considered legally blind.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD
Official Title  ICMJE A Phase 2b Multicenter Dose-Ranging Study Evaluating the Safety and Efficacy of Sunitinib Malate Depot Formulation (GB-102) Compared to Aflibercept in Subjects With Neovascular (Wet) Age-related Macular Degeneration (ALTISSIMO Study)
Brief Summary Phase 2b, multicenter, visual examiner-masked, randomized active-controlled, parallel-arm design study to evaluate the safety and duration of repeated IVT injections of 3 dose levels of GB-102 compared with aflibercept.
Detailed Description

Phase 2b, multicenter, visual examiner-masked, randomized active-controlled, parallel-arm design study to evaluate the safety and duration of the effect of GB-102, as measured by time to first rescue treatment across multiple dose levels of GB-102 administered every 6 months as compared to intravitreal (IVT) aflibercept administered every 2 months in subjects with neovascular (wet) age-related macular degeneration who have received prior induction with anti-vascular endothelial growth factor (VEGF)

Extension Study:

To monitor the safety and duration of effect of IVT GB-102 administered every 6 months compared to IVT aflibercept administered every 2 months in subjects in ALTISSIMO (Core Study) who complete all study visits through Month 12 (Day 360) and who do not require/receive rescue treatment at the Month 12 (Day 360) final study visit
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel-arm design
Masking: Single (Outcomes Assessor)
Masking Description:
Visual examiner-masked
Primary Purpose: Treatment
Condition  ICMJE Neovascular Age-Related Macular Degeneration
Intervention  ICMJE
  • Drug: Drug: GB-102
    Intravitreal injection of GB-102
    Other Name: Sunitinib malate
  • Drug: Aflibercept
    Intravitreal injection of aflibercept (2 mg dose)
    Other Name: Eylea
Study Arms  ICMJE
  • Experimental: GB-102 Dose 2 (1 mg)
    Participants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
    Intervention: Drug: Drug: GB-102
  • Experimental: GB-102 Dose 3 (2 mg)
    Participants will receive intravitreal (IVT) GB-102 (2 mg) in the study eye at Baseline, intravitreal (IVT) GB-102 (1 mg) at Month 6 and sham at Months 2, 4, 8 and 10.
    Intervention: Drug: Drug: GB-102
  • Active Comparator: Aflibercept 2 mg Dose
    Participants will receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
    Intervention: Drug: Aflibercept
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
Actual Enrollment  ICMJE
 (submitted: March 9, 2020) 		56
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2019) 		220
Estimated Study Completion Date  ICMJE June 2021
Actual Primary Completion Date December 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males or females ≥ 50 years of age
  • Presence of a CNV lesion secondary to AMD treated with at least 3 prior IVT injections of an anti-VEGF agent (aflibercept, bevacizumab, or ranibizumab).
  • Demonstrated response to prior anti-VEGF treatment since diagnosis
  • BCVA of 35 letters or better

Exclusion Criteria:

  • History, within 6 months prior to screening, of any of the following: myocardial infarction, any cardiac event requiring hospitalization, treatment for acute congestive heart failure, transient ischemic attack, or stroke
  • Uncontrolled hypertension, diabetes mellitus or IOP
  • Chronic renal disease
  • Abnormal liver function
  • Women who are pregnant or lactating
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 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 NCT03953079
Other Study ID Numbers  ICMJE GBV-102-002
Has Data Monitoring Committee No
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 Not Provided
Responsible Party Graybug Vision
Study Sponsor  ICMJE Graybug Vision
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Chief Medical Officer Graybug Vision, Inc.
PRS Account Graybug Vision
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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