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

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ClinicalTrials.gov Identifier: NCT03953079
Recruitment Status : Completed
First Posted : May 16, 2019
Last Update Posted : July 15, 2021
Sponsor:
Information provided by (Responsible Party):
Graybug Vision

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

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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
Actual Study Completion Date : June 3, 2021


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




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



Information from the National Library of Medicine

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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

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): NCT03953079


Locations
Show Show 33 study locations
Sponsors and Collaborators
Graybug Vision
Investigators
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Study Director: Chief Medical Officer Graybug Vision, Inc.
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Responsible Party: Graybug Vision
ClinicalTrials.gov Identifier: NCT03953079    
Other Study ID Numbers: GBV-102-002
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: July 15, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Graybug Vision:
Age-related macular degeneration
Choroidal neovascularization
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action