CClinicalTrials.gg
Sign In
CompletedNCT03953079ALTISSIMOUpdated Jan 19, 2022Results posted

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

A Phase 2 interventional study of Drug: GB-102 and Aflibercept in Neovascular Age-Related Macular Degeneration, sponsored by Graybug Vision. Completed at 33 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2022-01-19.

Sponsored by Graybug Vision · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Neovascular Age-Related Macular Degeneration

Keywords

  • Age-related macular degeneration (AMD)
  • Choroidal neovascularization
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 56 is close to the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Graybug Vision is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
56 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • DrugDrug: GB-102

    Intravitreal injection of GB-102

    Also known as: Sunitinib malate

  • DrugAflibercept

    Intravitreal injection of aflibercept (2 mg dose)

    Also known as: Eylea

06

What researchers measure

Primary outcomes

  1. Time to First Rescue Treatment

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

    Time frame: Baseline through 12 months

Secondary outcomes

  1. Time to Fulfillment of at Least One Rescue Criterion

    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

  2. Number of Times That at Least One Rescue Criterion is Met

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

    Time frame: Baseline through 12 months

  3. Number of Treatments, Including Both Rescue and Scheduled Study Treatments, During the Study

    Assessment of the number of treatments, including both rescue and scheduled study treatments, that occurred during the study

    Time frame: Baseline through 12 months

  4. Change From Baseline in Best-corrected Visual Acuity (BCVA) (ETDRS Letter Score) at All Visits

    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

  5. Categorical Change From Baseline in BCVA (ETDRS Letter Score) at All Visits

    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

  6. Frequency of Subjects With BCVA Worse Than 20/200 (Snellen Equivalent) at All Visits

    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

  7. Change From Baseline in Central Subfield Thickness (CST) (μm) at All Visits

    CST = central subfield thickness Assessment of change in CST (μm) measurement from baseline at all visits

    Time frame: Baseline through 12 months

  8. Frequency of Subjects With Absence of Exudation (Intra-/Sub-retinal Fluid/Cystoid Edema) at at All Visits

    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

07

Results

Posted Jan 11, 2022
Limitations and caveats
Small sample size hinders the ability to compare groups statistically.

Participant flow

Core Study
Participant flow — Core Study
MilestoneGB-102 1 mg/1 mgGB-102 2 mg/1 mgAflibercept 2 mg
Started212213
Completed201812
Not completed141
Withdrew: Withdrawal by subject121
Withdrew: Covid-19010
Withdrew: Difficulties leaving the house010
Extension Study
Participant flow — Extension Study
MilestoneGB-102 1 mg/1 mgGB-102 2 mg/1 mgAflibercept 2 mg
Started12106
Completed641
Not completed665
Withdrew: Withdrawal by subject100
Withdrew: Received rescue treatment565

Outcome measures

PrimaryTime to First Rescue Treatment

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

Time frame:
Baseline through 12 months
Reported as:
Median · months
Time to First Rescue Treatment
monthsGB-102 1 mg/1 mgGB-102 2 mg/1 mgAflibercept 2 mg
Time to First Rescue Treatment5 (3 to 8)4 (3 to 4)NA (NA to NA)
SecondaryTime to Fulfillment of at Least One Rescue Criterion

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
Reported as:
Median · months
Time to Fulfillment of at Least One Rescue Criterion
monthsGB-102 1 mg/1 mgGB-102 2 mg/1 mgAflibercept 2 mg
Time to Fulfillment of at Least One Rescue Criterion1.5 (1 to 2)2 (NA to NA)NA (6 to NA)
SecondaryNumber of Times That at Least One Rescue Criterion is Met

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

Time frame:
Baseline through 12 months
Reported as:
Mean · total monthly interval
Number of Times That at Least One Rescue Criterion is Met
total monthly intervalGB-102 1 mg/1 mgGB-102 2 mg/1 mgAflibercept 2 mg
Number of Times That at Least One Rescue Criterion is Met5.1 ± 3.386.1 ± 2.861.1 ± 1.26
SecondaryNumber of Treatments, Including Both Rescue and Scheduled Study Treatments, During the Study

Assessment of the number of treatments, including both rescue and scheduled study treatments, that occurred during the study

Time frame:
Baseline through 12 months
Reported as:
Median · Injections
Number of Treatments, Including Both Rescue and Scheduled Study Treatments, During the Study
InjectionsGB-102 1 mg/1 mgGB-102 2 mg/1 mgAflibercept 2 mg
Number of Treatments, Including Both Rescue and Scheduled Study Treatments, During the Study4 (1 to 8)4 (1 to 7)6 (3 to 7)
SecondaryChange From Baseline in Best-corrected Visual Acuity (BCVA) (ETDRS Letter Score) at All Visits

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
Reported as:
Mean · letters
Change From Baseline in Best-corrected Visual Acuity (BCVA) (ETDRS Letter Score) at All Visits
lettersGB-102 1 mg/1 mgGB-102 2 mg/1 mgDose
Change From Baseline in Best-corrected Visual Acuity (BCVA) (ETDRS Letter Score) at All Visits-7.4 ± 4.72-5.1 ± 4.371.8 ± 0.97
SecondaryCategorical Change From Baseline in BCVA (ETDRS Letter Score) at All Visits

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
Reported as:
Count of participants · Participants
Categorical Change From Baseline in BCVA (ETDRS Letter Score) at All Visits
ParticipantsGB-102 1 mg/1 mgGB-102 2 mg/1 mgAflibercept 2 mg
<= -15 letters740
>= -14 to <= -10 letters322
>= -9 to <= -5 letters111
>= -4 to <= 4 letters785
>= 5 to <= 9 letters223
>= 10 to <= 14 letters011
>= 15 letters000
SecondaryFrequency of Subjects With BCVA Worse Than 20/200 (Snellen Equivalent) at All Visits

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
Reported as:
Count of participants · Participants
Frequency of Subjects With BCVA Worse Than 20/200 (Snellen Equivalent) at All Visits
ParticipantsGB-102 1 mg/1 mgGB-102 2 mg/1 mgAflibercept 2 mg
Frequency of Subjects With BCVA Worse Than 20/200 (Snellen Equivalent) at All Visits310
SecondaryChange From Baseline in Central Subfield Thickness (CST) (μm) at All Visits

CST = central subfield thickness Assessment of change in CST (μm) measurement from baseline at all visits

Time frame:
Baseline through 12 months
Reported as:
Mean · microns
Change From Baseline in Central Subfield Thickness (CST) (μm) at All Visits
micronsGB-102 1 mg/1 mgGB-102 2 mg/1 mgAflibercept 2 mg
Change From Baseline in Central Subfield Thickness (CST) (μm) at All Visits41.7 ± 20.6927.2 ± 11.077.8 ± 15.46
SecondaryFrequency of Subjects With Absence of Exudation (Intra-/Sub-retinal Fluid/Cystoid Edema) at at All Visits

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
Reported as:
Count of participants · Participants
Frequency of Subjects With Absence of Exudation (Intra-/Sub-retinal Fluid/Cystoid Edema) at at All Visits
ParticipantsGB-102 1 mg/1 mgGB-102 2 mg/1 mgAflibercept 2 mg
Frequency of Subjects With Absence of Exudation (Intra-/Sub-retinal Fluid/Cystoid Edema) at at All Visits231

Adverse events

Collected over Baseline to Month 18. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
GB-102 1 mg/1 mg0/21 (0%)2/21 (9.5%)20/21 (95.2%)
GB-102 2 mg/1 mg0/22 (0%)4/22 (18.2%)22/22 (100%)
Aflibercept 2 mg0/13 (0%)1/13 (7.7%)8/13 (61.5%)
Most frequent serious events
Most frequent serious events
EventGB-102 1 mg/1 mgGB-102 2 mg/1 mgAflibercept 2 mg
Intraductal proliferative breast lesionNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/210/221/13
PneumoniaInfections and infestations1/210/220/13
SepsisInfections and infestations1/210/220/13
Retinal detachmentEye disorders0/211/220/13
Acute myeloid leukemiaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/211/220/13
Bladder cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/211/220/13
Atrial fibrillationCardiac disorders0/211/220/13
UrosepsisInfections and infestations0/211/220/13
Metastatic gastric cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/211/220/13
Most frequent other events
Showing 10 of 100
Most frequent other events
EventGB-102 1 mg/1 mgGB-102 2 mg/1 mgAflibercept 2 mg
Vitreous floatersEye disorders6/2110/222/13
IritisEye disorders5/2110/220/13
Product residue presentInvestigations4/216/220/13
Eye painEye disorders1/215/221/13
Retinal haemorrhageEye disorders4/214/221/13
Visual acuity reducedEye disorders3/214/220/13
Neovascular age-related macular degenerationEye disorders0/211/222/13
NasopharyngitisInfections and infestations3/211/222/13
CataractEye disorders2/213/220/13
EpiscleritisEye disorders0/213/220/13

Baseline characteristics

Safety Set includes all subjects all randomized subjects who receive at least one dose of study treatment.

Age, Categorical
Age, Categorical(Participants)GB-102 1 mg/1 mgGB-102 2 mg/1 mgAflibercept 2 mgTotal
<=18 years0000
Between 18 and 65 years0112
>=65 years21211254
Age, Continuous
Age, Continuous(years)GB-102 1 mg/1 mgGB-102 2 mg/1 mgAflibercept 2 mgTotal
Mean80 ± 8.0877.8 ± 8.5877.5 ± 9.1378.5 ± 8.44
Sex: Female, Male
Sex: Female, Male(Participants)GB-102 1 mg/1 mgGB-102 2 mg/1 mgAflibercept 2 mgTotal
Female1513836
Male69520
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)GB-102 1 mg/1 mgGB-102 2 mg/1 mgAflibercept 2 mgTotal
Hispanic or Latino1001
Not Hispanic or Latino20221355
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)GB-102 1 mg/1 mgGB-102 2 mg/1 mgAflibercept 2 mgTotal
American Indian or Alaska Native0000
Asian1012
Native Hawaiian or Other Pacific Islander0000
Black or African American0000
White20221254
More than one race0000
Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(participants)GB-102 1 mg/1 mgGB-102 2 mg/1 mgAflibercept 2 mgTotal
United States21221356
Best Corrected Visual Acuity (ETDRS Letters)
Best Corrected Visual Acuity (ETDRS Letters)(ETDRS letters)GB-102 1 mg/1 mgGB-102 2 mg/1 mgAflibercept 2 mgTotal
Mean70.8 ± 11.5070.7 ± 9.9269.6 ± 14.6770.5 ± 11.52
Central Subfield Thickness
Central Subfield Thickness(microns)GB-102 1 mg/1 mgGB-102 2 mg/1 mgAflibercept 2 mgTotal
Mean211.0 ± 47.14232.5 ± 54.37217.5 ± 31.66221.0 ± 47.42
08

Study locations

33 sites
  • Retinal Consultants AZ
    Gilbert, Arizona 85296, United States
  • Retinal Research Institute
    Phoenix, Arizona 85017, United States
  • California Retina Research Consultants
    Bakersfield, California 93309, United States
  • Retinal Diagnostic Center of Northern California
    Campbell, California 95008, United States
  • The Retina Partners
    Encino, California 91436, United States
  • Retina Consultants of Orange County
    Fullerton, California 92835, United States
  • Northern California Retina Vitreous Associates Medical Group, Inc.
    Mountain View, California 94040, United States
  • West Coast Retina Medical Group, Inc.
    San Francisco, California 94109, United States
  • California Retina Consultants - CRC
    Santa Barbara, California 93103, United States
  • Bay Area Retina Associates
    Walnut Creek, California 94598, United States
  • Specialty Retina Center
    Coral Springs, Florida 32503, United States
  • Florida Retina Institute
    Orlando, Florida 32806-1101, United States
  • Retina Specialty Institute
    Pensacola, Florida 32503, United States
  • Eye Associates of Pinellas
    Pinellas Park, Florida 33782, United States
  • Southeast Retina Center
    Augusta, Georgia 30909, United States
  • Retina Consultants of Hawaii
    'Aiea, Hawaii 96701, United States
  • University Retina and Macula
    Lemont, Illinois 60439, United States
  • Wolfe Eye Clinic - West Des Moines
    Des Moines, Iowa 50266, United States
  • Eye Associates of Northeast Louisiana
    West Monroe, Louisiana 71291, United States
  • Cumberland Valley Retina Consultants
    Hagerstown, Maryland 21740, United States
  • Mid Atlantic Retina Specialists
    Hagerstown, Maryland 21740, United States
  • Sierra Eye Associates
    Reno, Nevada 89502, United States
  • Ophthalmic Consultants of Long Island
    Oceanside, New York 11572, United States
  • Sterling Research
    Cincinnati, Ohio 45219, United States
  • Black Hills Regional Eye Institute
    Rapid City, South Dakota 57701, United States
  • Retina Research Institute of Texas
    Abilene, Texas 79606, United States
  • Austin Retina Associates
    Austin, Texas 78705, United States
  • Retina Research Center, PLLC
    Austin, Texas 78705, United States
  • Retina Specialists
    Plano, Texas 75093, United States
  • Retina Consultants of Houston
    The Woodlands, Texas 77384, United States
  • Strategic Clinical Research Group LLC
    Willow Park, Texas 76087, United States
  • Piedmont Eye Center
    Lynchburg, Virginia 24502, United States
  • Retina Center NW PLLC
    Silverdale, Washington 98383, United States
09

References and documents

Study documents

  • Study protocol · Sep 8, 2020
  • Statistical analysis plan · Jan 8, 2021

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03953079
Lead sponsor
Graybug Vision
Responsible party
Sponsor
First posted
May 16, 2019
Start date
Sep 26, 2019
Primary completion
Dec 15, 2020
Completion
Jun 3, 2021
Results posted
Jan 11, 2022
Last update
Jan 19, 2022

Study contacts

Chief Medical Officer
study director · Graybug Vision, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Macular Degeneration→

Other studies from this sponsor

Graybug Vision

Start the discussion