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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 : Recruiting
First Posted : May 16, 2019
Last Update Posted : October 3, 2019
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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 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
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : May 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 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

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 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


Secondary Outcome Measures :
  1. 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

  2. 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


  3. 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

  4. 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


  5. 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


  6. Time to rescue treatment [ Time Frame: Baseline through 12 months ]
    Assessment of time to rescue treatment over 12 months of treatment

  7. Mean number of intravitreal injections [ Time Frame: Baseline through 12 months ]
    Assessment of the mean number of intravitreal injections over 12 months of treatment

  8. 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

  9. 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


  10. 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


  11. 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.




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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


Contacts
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Contact: VP, Global Clinical Development Operations (650) 487-2800 vsmith@graybug.com

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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     History of Changes
Other Study ID Numbers: GBV-102-002
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019

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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