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

Sponsor
Graybug Vision (Industry)
Overall Status
Completed
CT.gov ID
NCT03953079
Collaborator
(none)
56
Enrollment
33
Locations
3
Arms
20.2
Actual Duration (Months)
1.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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
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

Study Type:
Interventional
Actual Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel-arm designParallel-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 :
Sep 26, 2019
Actual Primary Completion Date :
Dec 15, 2020
Actual Study Completion Date :
Jun 3, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: GB-102 1 mg/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 Names:
  • Sunitinib malate

    		•
    Experimental: GB-102 2 mg/1 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 Names:
  • Sunitinib malate

    		•
    Active Comparator: Aflibercept 2 mg

    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 Names:
  • Eylea

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time to First Rescue Treatment [Baseline through 12 months]

      Kaplan-Meier estimate of the median time to first rescue treatment.

    Secondary Outcome Measures

    1. Time to Fulfillment of at Least One Rescue Criterion [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 [Baseline through 12 months]

      Assessment of the number of monthly intervals that at least one rescue criterion is met

    3. Number of Treatments, Including Both Rescue and Scheduled Study Treatments, During the Study [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 Best-corrected Visual Acuity (BCVA) (ETDRS Letter Score) at All Visits [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 [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 [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 Central Subfield Thickness (CST) (μm) at All Visits [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 [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

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Males or females ≥ 50 years of age

    • Presence of a choroidal neovascularization (CNV) lesion secondary to AMD treated with at least 3 prior intravitreal (IVT) injections of an anti-vascular endothelial growth factor (VEGF) agent (aflibercept, bevacizumab, or ranibizumab).

    • Demonstrated response to prior anti-VEGF treatment since diagnosis

    • Best-corrected visual acuity (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 intraocular pressure (IOP)

    • Chronic renal disease

    • Abnormal liver function

    • Women who are pregnant or lactating

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Retinal Consultants AZ Gilbert Arizona United States 85296
    2 Retinal Research Institute Phoenix Arizona United States 85017
    3 California Retina Research Consultants Bakersfield California United States 93309
    4 Retinal Diagnostic Center of Northern California Campbell California United States 95008
    5 The Retina Partners Encino California United States 91436
    6 Retina Consultants of Orange County Fullerton California United States 92835
    7 Northern California Retina Vitreous Associates Medical Group, Inc. Mountain View California United States 94040
    8 West Coast Retina Medical Group, Inc. San Francisco California United States 94109
    9 California Retina Consultants - CRC Santa Barbara California United States 93103
    10 Bay Area Retina Associates Walnut Creek California United States 94598
    11 Specialty Retina Center Coral Springs Florida United States 32503
    12 Florida Retina Institute Orlando Florida United States 32806-1101
    13 Retina Specialty Institute Pensacola Florida United States 32503
    14 Eye Associates of Pinellas Pinellas Park Florida United States 33782
    15 Southeast Retina Center Augusta Georgia United States 30909
    16 Retina Consultants of Hawaii 'Aiea Hawaii United States 96701
    17 University Retina and Macula Lemont Illinois United States 60439
    18 Wolfe Eye Clinic - West Des Moines Des Moines Iowa United States 50266
    19 Eye Associates of Northeast Louisiana West Monroe Louisiana United States 71291
    20 Cumberland Valley Retina Consultants Hagerstown Maryland United States 21740
    21 Mid Atlantic Retina Specialists Hagerstown Maryland United States 21740
    22 Sierra Eye Associates Reno Nevada United States 89502
    23 Ophthalmic Consultants of Long Island Oceanside New York United States 11572
    24 Sterling Research Cincinnati Ohio United States 45219
    25 Black Hills Regional Eye Institute Rapid City South Dakota United States 57701
    26 Retina Research Institute of Texas Abilene Texas United States 79606
    27 Austin Retina Associates Austin Texas United States 78705
    28 Retina Research Center, PLLC Austin Texas United States 78705
    29 Retina Specialists Plano Texas United States 75093
    30 Retina Consultants of Houston The Woodlands Texas United States 77384
    31 Strategic Clinical Research Group LLC Willow Park Texas United States 76087
    32 Piedmont Eye Center Lynchburg Virginia United States 24502
    33 Retina Center NW PLLC Silverdale Washington United States 98383

    Sponsors and Collaborators

    • Graybug Vision

    Investigators

    • Study Director: Chief Medical Officer, Graybug Vision, Inc.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Graybug Vision
    ClinicalTrials.gov Identifier:
    NCT03953079
    Other Study ID Numbers:
    • GBV-102-002
    First Posted:
    May 16, 2019
    Last Update Posted:
    Jan 19, 2022
    Last Verified:
    Jan 1, 2022
    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 (AMD)
    Choroidal neovascularization
    Additional relevant MeSH terms:
    Macular Degeneration
    Sunitinib
    Aflibercept

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title GB-102 1 mg/1 mg GB-102 2 mg/1 mg Aflibercept 2 mg
    Arm/Group Description Participants 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. Participants 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. Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
    Period Title: Core Study
    STARTED 21 22 13
    COMPLETED 20 18 12
    NOT COMPLETED 1 4 1
    Period Title: Core Study
    STARTED 12 10 6
    COMPLETED 6 4 1
    NOT COMPLETED 6 6 5

    Baseline Characteristics

    Arm/Group Title GB-102 1 mg/1 mg GB-102 2 mg/1 mg Aflibercept 2 mg Total
    Arm/Group Description Participants 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. Participants 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. Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10. Total of all reporting groups
    Overall Participants 21 22 13 56
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    0
    0%
    1
    4.5%
    1
    7.7%
    2
    3.6%
    >=65 years
    21
    100%
    21
    95.5%
    12
    92.3%
    54
    96.4%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    80
    (8.08)
    77.8
    (8.58)
    77.5
    (9.13)
    78.5
    (8.44)
    Sex: Female, Male (Count of Participants)
    Female
    15
    71.4%
    13
    59.1%
    8
    61.5%
    36
    64.3%
    Male
    6
    28.6%
    9
    40.9%
    5
    38.5%
    20
    35.7%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    1
    4.8%
    0
    0%
    0
    0%
    1
    1.8%
    Not Hispanic or Latino
    20
    95.2%
    22
    100%
    13
    100%
    55
    98.2%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    1
    4.8%
    0
    0%
    1
    7.7%
    2
    3.6%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    White
    20
    95.2%
    22
    100%
    12
    92.3%
    54
    96.4%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    21
    100%
    22
    100%
    13
    100%
    56
    100%
    Best Corrected Visual Acuity (ETDRS Letters) (ETDRS letters) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [ETDRS letters]
    70.8
    (11.50)
    70.7
    (9.92)
    69.6
    (14.67)
    70.5
    (11.52)
    Central Subfield Thickness (microns) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [microns]
    211.0
    (47.14)
    232.5
    (54.37)
    217.5
    (31.66)
    221.0
    (47.42)

    Outcome Measures

    1. Primary Outcome
    Title Time to First Rescue Treatment
    Description Kaplan-Meier estimate of the median time to first rescue treatment.
    Time Frame Baseline through 12 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title GB-102 1 mg/1 mg GB-102 2 mg/1 mg Aflibercept 2 mg
    Arm/Group Description Participants 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. Participants 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. Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
    Measure Participants 21 22 13
    Median (80% Confidence Interval) [months]
    5
    4
    NA
    2. Secondary Outcome
    Title Time to Fulfillment of at Least One Rescue Criterion
    Description Assessment of time to fulfillment of at least one rescue criterion starting at the Month 6 visit through to the Month 12 visit
    Time Frame 6 months through 12 months

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set which include all randomized subjects who received at least one dose of study treatment and complete a baseline and at least one post-baseline visit.
    Arm/Group Title GB-102 1 mg/1 mg GB-102 2 mg/1 mg Aflibercept 2 mg
    Arm/Group Description Participants 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. Participants 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. Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
    Measure Participants 16 14 12
    Median (80% Confidence Interval) [months]
    1.5
    2
    NA
    3. Secondary Outcome
    Title Number of Times That at Least One Rescue Criterion is Met
    Description Assessment of the number of monthly intervals that at least one rescue criterion is met
    Time Frame Baseline through 12 months

    Outcome Measure Data

    Analysis Population Description
    The Full Analysis Set (FAS) will include all randomized subjects who receive at least one dose of study treatment, and complete a baseline and at least one post-baseline visit.
    Arm/Group Title GB-102 1 mg/1 mg GB-102 2 mg/1 mg Aflibercept 2 mg
    Arm/Group Description Participants 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. Participants 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. Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
    Measure Participants 21 22 13
    Mean (Standard Error) [total monthly interval]
    5.1
    (3.38)
    6.1
    (2.86)
    1.1
    (1.26)
    4. Secondary Outcome
    Title Number of Treatments, Including Both Rescue and Scheduled Study Treatments, During the Study
    Description Assessment of the number of treatments, including both rescue and scheduled study treatments, that occurred during the study
    Time Frame Baseline through 12 months

    Outcome Measure Data

    Analysis Population Description
    The Full Analysis Set (FAS) will include all randomized subjects who receive at least one dose of study treatment, and complete a baseline and at least one post-baseline visit.
    Arm/Group Title GB-102 1 mg/1 mg GB-102 2 mg/1 mg Aflibercept 2 mg
    Arm/Group Description Participants 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. Participants 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. Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
    Measure Participants 21 22 13
    Median (Full Range) [Injections]
    4
    4
    6
    5. Secondary Outcome
    Title Change From Baseline in Best-corrected Visual Acuity (BCVA) (ETDRS Letter Score) at All Visits
    Description 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
    Time Frame Baseline through 12 months

    Outcome Measure Data

    Analysis Population Description
    The Full Analysis Set (FAS) will include all randomized subjects who receive at least one dose of study treatment, and complete a baseline and at least one post-baseline visit.
    Arm/Group Title GB-102 1 mg/1 mg GB-102 2 mg/1 mg Dose
    Arm/Group Description Participants 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. Participants 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. Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
    Measure Participants 20 18 12
    Mean (Standard Deviation) [letters]
    -7.4
    (4.72)
    -5.1
    (4.37)
    1.8
    (0.97)
    6. Secondary Outcome
    Title Categorical Change From Baseline in BCVA (ETDRS Letter Score) at All Visits
    Description 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
    Time Frame Baseline through 12 months

    Outcome Measure Data

    Analysis Population Description
    The Full Analysis Set (FAS) will include all randomized subjects who receive at least one dose of study treatment, and complete a baseline and at least one post-baseline visit.
    Arm/Group Title GB-102 1 mg/1 mg GB-102 2 mg/1 mg Aflibercept 2 mg
    Arm/Group Description Participants 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. Participants 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. Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
    Measure Participants 20 18 12
    <= -15 letters
    7
    33.3%
    4
    18.2%
    0
    0%
    >= -14 to <= -10 letters
    3
    14.3%
    2
    9.1%
    2
    15.4%
    >= -9 to <= -5 letters
    1
    4.8%
    1
    4.5%
    1
    7.7%
    >= -4 to <= 4 letters
    7
    33.3%
    8
    36.4%
    5
    38.5%
    >= 5 to <= 9 letters
    2
    9.5%
    2
    9.1%
    3
    23.1%
    >= 10 to <= 14 letters
    0
    0%
    1
    4.5%
    1
    7.7%
    >= 15 letters
    0
    0%
    0
    0%
    0
    0%
    7. Secondary Outcome
    Title Frequency of Subjects With BCVA Worse Than 20/200 (Snellen Equivalent) at All Visits
    Description 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.
    Time Frame Baseline through 12 months

    Outcome Measure Data

    Analysis Population Description
    The Full Analysis Set (FAS) will include all randomized subjects who receive at least one dose of study treatment, and complete a baseline and at least one post-baseline visit.
    Arm/Group Title GB-102 1 mg/1 mg GB-102 2 mg/1 mg Aflibercept 2 mg
    Arm/Group Description Participants 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. Participants 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. Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
    Measure Participants 20 18 12
    Count of Participants [Participants]
    3
    14.3%
    1
    4.5%
    0
    0%
    8. Secondary Outcome
    Title Change From Baseline in Central Subfield Thickness (CST) (μm) at All Visits
    Description CST = central subfield thickness Assessment of change in CST (μm) measurement from baseline at all visits
    Time Frame Baseline through 12 months

    Outcome Measure Data

    Analysis Population Description
    The Full Analysis Set (FAS) will include all randomized subjects who receive at least one dose of study treatment, and complete a baseline and at least one post-baseline visit.
    Arm/Group Title GB-102 1 mg/1 mg GB-102 2 mg/1 mg Aflibercept 2 mg
    Arm/Group Description Participants 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. Participants 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. Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
    Measure Participants 20 18 12
    Mean (Standard Deviation) [microns]
    41.7
    (20.69)
    27.2
    (11.07)
    7.8
    (15.46)
    9. Secondary Outcome
    Title Frequency of Subjects With Absence of Exudation (Intra-/Sub-retinal Fluid/Cystoid Edema) at at All Visits
    Description Assessment of the frequency of subjects with absence of exudation (intra-/sub-retinal fluid/cystoid edema) at all visits
    Time Frame Baseline through 12 months

    Outcome Measure Data

    Analysis Population Description
    The Full Analysis Set (FAS) will include all randomized subjects who receive at least one dose of study treatment, and complete a baseline and at least one post-baseline visit.
    Arm/Group Title GB-102 1 mg/1 mg GB-102 2 mg/1 mg Aflibercept 2 mg
    Arm/Group Description Participants 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. Participants 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. Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
    Measure Participants 16 16 9
    Count of Participants [Participants]
    2
    9.5%
    3
    13.6%
    1
    7.7%

    Adverse Events

    Time Frame Baseline to Month 18
    Adverse Event Reporting Description
    Arm/Group Title GB-102 1 mg/1 mg GB-102 2 mg/1 mg Aflibercept 2 mg
    Arm/Group Description Participants 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. Participants 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. Participants receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
    All Cause Mortality
    GB-102 1 mg/1 mg GB-102 2 mg/1 mg Aflibercept 2 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/21 (0%) 0/22 (0%) 0/13 (0%)
    Serious Adverse Events
    GB-102 1 mg/1 mg GB-102 2 mg/1 mg Aflibercept 2 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/21 (9.5%) 4/22 (18.2%) 1/13 (7.7%)
    Cardiac disorders
    Atrial fibrillation 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Eye disorders
    Retinal detachment 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Infections and infestations
    Pneumonia 1/21 (4.8%) 1 0/22 (0%) 0 0/13 (0%) 0
    Sepsis 1/21 (4.8%) 1 0/22 (0%) 0 0/13 (0%) 0
    Urosepsis 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukemia 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Bladder cancer 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Metastatic gastric cancer 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Intraductal proliferative breast lesion 0/21 (0%) 0 0/22 (0%) 0 1/13 (7.7%) 1
    Other (Not Including Serious) Adverse Events
    GB-102 1 mg/1 mg GB-102 2 mg/1 mg Aflibercept 2 mg
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 20/21 (95.2%) 22/22 (100%) 8/13 (61.5%)
    Blood and lymphatic system disorders
    Coagulopathy 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Cardiac disorders
    Arteriosclerosis coronary artery 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Cardiac failure congestive 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Atrioventricular block second degree 1/21 (4.8%) 1 0/22 (0%) 0 0/13 (0%) 0
    Ear and labyrinth disorders
    Vertigo 1/21 (4.8%) 1 0/22 (0%) 0 0/13 (0%) 0
    Eye disorders
    Vitreous floaters 6/21 (28.6%) 8 10/22 (45.5%) 13 2/13 (15.4%) 2
    Iritis 5/21 (23.8%) 6 10/22 (45.5%) 11 0/13 (0%) 0
    Retinal haemorrhage 4/21 (19%) 4 4/22 (18.2%) 4 1/13 (7.7%) 1
    Visual acuity reduced 3/21 (14.3%) 4 4/22 (18.2%) 4 0/13 (0%) 0
    Subretinal fluid 2/21 (9.5%) 2 2/22 (9.1%) 2 1/13 (7.7%) 1
    Eye pain 1/21 (4.8%) 1 5/22 (22.7%) 6 1/13 (7.7%) 1
    Cataract 2/21 (9.5%) 4 3/22 (13.6%) 3 0/13 (0%) 0
    Visual impairment 1/21 (4.8%) 1 2/22 (9.1%) 3 0/13 (0%) 0
    Posterior capsule opacification 1/21 (4.8%) 1 1/22 (4.5%) 1 1/13 (7.7%) 2
    Vitritis 1/21 (4.8%) 1 1/22 (4.5%) 1 0/13 (0%) 0
    Subretinal fibrosis 1/21 (4.8%) 1 0/22 (0%) 0 1/13 (7.7%) 1
    Conjunctival hyperaemia 1/21 (4.8%) 1 0/22 (0%) 0 0/13 (0%) 0
    Retinal oedema 1/21 (4.8%) 1 0/22 (0%) 0 0/13 (0%) 0
    Retinal thickening 1/21 (4.8%) 1 0/22 (0%) 0 0/13 (0%) 0
    Uveitis 1/21 (4.8%) 1 0/22 (0%) 0 0/13 (0%) 0
    Vision blurred 2/21 (9.5%) 2 0/22 (0%) 0 0/13 (0%) 0
    Vitreous detachment 1/21 (4.8%) 2 0/22 (0%) 0 1/13 (7.7%) 2
    Episcleritis 0/21 (0%) 0 3/22 (13.6%) 3 0/13 (0%) 0
    Dry eye 0/21 (0%) 0 2/22 (9.1%) 2 1/13 (7.7%) 2
    Anterior chamber inflammation 0/21 (0%) 0 2/22 (9.1%) 3 0/13 (0%) 0
    Cataract subcapsular 0/21 (0%) 0 2/22 (9.1%) 2 0/13 (0%) 0
    Corneal oedema 0/21 (0%) 0 2/22 (9.1%) 3 0/13 (0%) 0
    Keratic precipitates 0/21 (0%) 0 2/22 (9.1%) 4 0/13 (0%) 0
    Photophobia 0/21 (0%) 0 2/22 (9.1%) 3 0/13 (0%) 0
    Choroidal neovascularisation 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Dermatochalasis 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Eye allergy 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Iris adhesions 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Papilloedema 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Punctate keratitis 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Scleritis 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Vitreous degeneration 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Neovascular age-related macular degeneration 0/21 (0%) 0 1/22 (4.5%) 1 2/13 (15.4%) 3
    Subretinal hyperreflective exudation 0/21 (0%) 0 0/22 (0%) 0 1/13 (7.7%) 1
    Lens discolouration 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Dry age-related macular degeneration 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Gastrointestinal disorders
    Diarrhoea 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Loose tooth 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Constipation 1/21 (4.8%) 1 0/22 (0%) 0 0/13 (0%) 0
    Diverticulum 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    General disorders
    Localised oedema 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Hypothermia 1/21 (4.8%) 1 0/22 (0%) 0 0/13 (0%) 0
    Immune system disorders
    Seasonal allergy 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Infections and infestations
    Conjunctivitis 2/21 (9.5%) 2 0/22 (0%) 0 0/13 (0%) 0
    Hordeolum 0/21 (0%) 0 1/22 (4.5%) 1 1/13 (7.7%) 1
    Nasopharyngitis 3/21 (14.3%) 3 1/22 (4.5%) 1 2/13 (15.4%) 2
    Sinusitis 0/21 (0%) 0 3/22 (13.6%) 3 0/13 (0%) 0
    Urinary tract infection 1/21 (4.8%) 1 1/22 (4.5%) 1 1/13 (7.7%) 1
    Asymptomatic COVID-19 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Infected dermal cyst 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Pneumonia 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Cystitis 0/21 (0%) 0 0/22 (0%) 0 1/13 (7.7%) 1
    Gingival abscess 0/21 (0%) 0 0/22 (0%) 0 1/13 (7.7%) 1
    Gastroenteritis viral 1/21 (4.8%) 1 0/22 (0%) 0 0/13 (0%) 0
    Herpes zoster 1/21 (4.8%) 1 0/22 (0%) 0 0/13 (0%) 0
    Pyelonephritis 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Injury, poisoning and procedural complications
    Muscle strain 1/21 (4.8%) 1 0/22 (0%) 0 0/13 (0%) 0
    Alcohol poisoning 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Concussion 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Skin abrasion 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Skin laceration 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Wrist fracture 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Fall 0/21 (0%) 0 0/22 (0%) 0 1/13 (7.7%) 1
    Investigations
    Product residue present 4/21 (19%) 4 6/22 (27.3%) 7 0/13 (0%) 0
    Intraocular pressure increased 1/21 (4.8%) 1 1/22 (4.5%) 4 0/13 (0%) 0
    Optical coherence tomography abnormal 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Blood pressure increased 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Metabolism and nutrition disorders
    Diabetes mellitus 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Hyperlipidaemia 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Hypokalaemia 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 2/21 (9.5%) 2 1/22 (4.5%) 1 0/13 (0%) 0
    Back pain 1/21 (4.8%) 2 0/22 (0%) 0 1/13 (7.7%) 2
    Bursitis 1/21 (4.8%) 1 0/22 (0%) 0 0/13 (0%) 0
    Tendonitis 1/21 (4.8%) 1 0/22 (0%) 0 0/13 (0%) 0
    Arthritis 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Neck pain 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Squamous cell carcinoma of skin 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Abdominal wall neoplasm malignant 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Skin cancer 0/21 (0%) 0 0/22 (0%) 0 1/13 (7.7%) 1
    Nervous system disorders
    Dementia 2/21 (9.5%) 2 0/22 (0%) 0 0/13 (0%) 0
    Sinus headache 1/21 (4.8%) 1 0/22 (0%) 0 0/13 (0%) 0
    Headache 0/21 (0%) 0 3/22 (13.6%) 3 0/13 (0%) 0
    Syncope 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Psychiatric disorders
    Insomnia 1/21 (4.8%) 1 0/22 (0%) 0 0/13 (0%) 0
    Delirium 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Renal and urinary disorders
    Nephrolithiasis 1/21 (4.8%) 1 0/22 (0%) 0 0/13 (0%) 0
    Hypertonic bladder 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Cough 1/21 (4.8%) 1 2/22 (9.1%) 2 0/13 (0%) 0
    Dyspnoea exertional 1/21 (4.8%) 1 0/22 (0%) 0 0/13 (0%) 0
    Oropharyngeal pain 1/21 (4.8%) 1 0/22 (0%) 0 0/13 (0%) 0
    Asthma 0/21 (0%) 0 0/22 (0%) 0 1/13 (7.7%) 1
    Skin and subcutaneous tissue disorders
    Ecchymosis 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Vascular disorders
    Arteriosclerosis 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0
    Hypertension 0/21 (0%) 0 2/22 (9.1%) 2 0/13 (0%) 0
    Aortic stenosis 0/21 (0%) 0 1/22 (4.5%) 1 0/13 (0%) 0

    Limitations/Caveats

    Small sample size hinders the ability to compare groups statistically.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Any investigator wishing to publish or present any study finding must present a manuscript or abstract to Graybug Vision 120 days prior to submission for publication or presentation to provide Graybug Vision an opportunity for review and comment.

    Results Point of Contact

    Name/Title Executive Director, Biostatistics
    Organization Graybug Vision
    Phone 650-459-4235
    Email pdinh@graybug.vision
    Responsible Party:
    Graybug Vision
    ClinicalTrials.gov Identifier:
    NCT03953079
    Other Study ID Numbers:
    • GBV-102-002
    First Posted:
    May 16, 2019
    Last Update Posted:
    Jan 19, 2022
    Last Verified:
    Jan 1, 2022