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

Primary Purpose

Neovascular Age-Related Macular Degeneration

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Drug: GB-102
Aflibercept
Sponsored by
Graybug Vision
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Age-Related Macular Degeneration focused on measuring Age-related macular degeneration (AMD), Choroidal neovascularization

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Retinal Consultants AZ
  • Retinal Research Institute
  • California Retina Research Consultants
  • Retinal Diagnostic Center of Northern California
  • The Retina Partners
  • Retina Consultants of Orange County
  • Northern California Retina Vitreous Associates Medical Group, Inc.
  • West Coast Retina Medical Group, Inc.
  • California Retina Consultants - CRC
  • Bay Area Retina Associates
  • Specialty Retina Center
  • Florida Retina Institute
  • Retina Specialty Institute
  • Eye Associates of Pinellas
  • Southeast Retina Center
  • Retina Consultants of Hawaii
  • University Retina and Macula
  • Wolfe Eye Clinic - West Des Moines
  • Eye Associates of Northeast Louisiana
  • Cumberland Valley Retina Consultants
  • Mid Atlantic Retina Specialists
  • Sierra Eye Associates
  • Ophthalmic Consultants of Long Island
  • Sterling Research
  • Black Hills Regional Eye Institute
  • Retina Research Institute of Texas
  • Austin Retina Associates
  • Retina Research Center, PLLC
  • Retina Specialists
  • Retina Consultants of Houston
  • Strategic Clinical Research Group LLC
  • Piedmont Eye Center
  • Retina Center NW PLLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

GB-102 1 mg/1 mg

GB-102 2 mg/1 mg

Aflibercept 2 mg

Arm Description

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.

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.

Participants will receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.

Outcomes

Primary Outcome Measures

Time to First Rescue Treatment
Kaplan-Meier estimate of the median time to first rescue treatment.

Secondary Outcome Measures

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
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
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
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
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
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.
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
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

Full Information

First Posted
May 13, 2019
Last Updated
January 10, 2022
Sponsor
Graybug Vision
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1. Study Identification

Unique Protocol Identification Number
NCT03953079
Brief Title
A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD
Acronym
ALTISSIMO
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 26, 2019 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
June 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Graybug Vision

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-Related Macular Degeneration
Keywords
Age-related macular degeneration (AMD), Choroidal neovascularization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Parallel-arm design
Masking
Outcomes Assessor
Masking Description
Visual examiner-masked
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GB-102 1 mg/1 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
GB-102 2 mg/1 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Aflibercept 2 mg
Arm Type
Active Comparator
Arm Description
Participants will receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
Intervention Type
Drug
Intervention Name(s)
Drug: GB-102
Other Intervention Name(s)
Sunitinib malate
Intervention Description
Intravitreal injection of GB-102
Intervention Type
Drug
Intervention Name(s)
Aflibercept
Other Intervention Name(s)
Eylea
Intervention Description
Intravitreal injection of aflibercept (2 mg dose)
Primary Outcome Measure Information:
Title
Time to First Rescue Treatment
Description
Kaplan-Meier estimate of the median time to first rescue treatment.
Time Frame
Baseline through 12 months
Secondary Outcome Measure Information:
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
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
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
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
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
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
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer
Organizational Affiliation
Graybug Vision, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Retinal Consultants AZ
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85296
Country
United States
Facility Name
Retinal Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85017
Country
United States
Facility Name
California Retina Research Consultants
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Retinal Diagnostic Center of Northern California
City
Campbell
State/Province
California
ZIP/Postal Code
95008
Country
United States
Facility Name
The Retina Partners
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Retina Consultants of Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Northern California Retina Vitreous Associates Medical Group, Inc.
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
West Coast Retina Medical Group, Inc.
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
California Retina Consultants - CRC
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93103
Country
United States
Facility Name
Bay Area Retina Associates
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Specialty Retina Center
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Florida Retina Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806-1101
Country
United States
Facility Name
Retina Specialty Institute
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Eye Associates of Pinellas
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33782
Country
United States
Facility Name
Southeast Retina Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Retina Consultants of Hawaii
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
University Retina and Macula
City
Lemont
State/Province
Illinois
ZIP/Postal Code
60439
Country
United States
Facility Name
Wolfe Eye Clinic - West Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Eye Associates of Northeast Louisiana
City
West Monroe
State/Province
Louisiana
ZIP/Postal Code
71291
Country
United States
Facility Name
Cumberland Valley Retina Consultants
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Mid Atlantic Retina Specialists
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Ophthalmic Consultants of Long Island
City
Oceanside
State/Province
New York
ZIP/Postal Code
11572
Country
United States
Facility Name
Sterling Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Black Hills Regional Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Retina Research Institute of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Austin Retina Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retina Research Center, PLLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retina Specialists
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Retina Consultants of Houston
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
Strategic Clinical Research Group LLC
City
Willow Park
State/Province
Texas
ZIP/Postal Code
76087
Country
United States
Facility Name
Piedmont Eye Center
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Facility Name
Retina Center NW PLLC
City
Silverdale
State/Province
Washington
ZIP/Postal Code
98383
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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