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A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Neovascular (Wet) Age-related Macular Degeneration

Primary Purpose

Neovascular Age-Related Macular Degeneration

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
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, Choroidal neovascularization

Eligibility Criteria

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

Key Inclusion Criteria:

  1. Males or females of any race, ≥ 50 years of age
  2. Presence of an active CNV lesion secondary to AMD treated with at least 3 monthly injections of an anti-VEGF agent (aflibercept, bevacizumab, or ranibizumab)
  3. Evidence of increased vascular permeability and/or loss of visual acuity

Key Exclusion Criteria:

  1. 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
  2. Uncontrolled hypertension, diabetes mellitus, IOP, hypothyroidism, or hyperthyroidism
  3. Chronic renal disease
  4. Abnormal liver function
  5. Women who are pregnant or lactating

Sites / Locations

  • Retinal Consultants of Arizona
  • Retina-Vitreous Associates Medical Group
  • Midwest Eye Institute
  • Ophthalmic Consultants of Long Island
  • Retina Research Institute of Texas
  • Texas Retina Associates
  • Retina Research Center, PLLC
  • Medical Center Ophthalmology Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Experimental: Phase 1 - GB-102

Experimental: Phase 2 - GB-102

Active Comparator: Phase 2 - Aflibercept

Arm Description

Subjects will be assigned to 1 of 4 cohorts to receive a single intravitreal injection of up to 2.0 mg (50 μL) GB-102.

Low dose or high dose injected every 6 months

Aflibercept 2 mg injected every 2 months

Outcomes

Primary Outcome Measures

Phase 1: Occurrence of ocular and nonocular adverse events (AEs)
Number of adverse events in total and number of subjects with an adverse event
Phase 2: Change from baseline in best corrected visual acuity by ETDRS
Mean change from Baseline at Day 270 (Month 9) in best corrected visual acuity (BCVA) measured by early treatment diabetic retinopathy (ETDRS)

Secondary Outcome Measures

Phase 1: Change from baseline in BCVA by ETDRS
Mean change from baseline in mean BCVA measured by early treatment diabetic retinopathy (ETDRS) method
Phase 1: Change from baseline in sub-retinal thickness
Mean change from baseline in sub-retinal thickness (microns) by spectral domain - optical coherence tomography (SD-OCT)
Phase 1: Change from baseline in retinal fluid by SD-OCT
Assessment of retinal fluid by SD-OCT
Phase 1: Change from baseline in total lesion area by FA/CFP
Lesion area (total) by fluorescein angiography/color fundus photography (FA/CFP)
Phase 1: Change from baseline in CNV lesion area by FA/CFP
CNV lesion area by FA/CFP
Phase 1: Change from baseline in fluorescein leakage area by FA/CFP
Area of fluorescein leakage by FA/CFP
Phase 1: Rescue medication
Proportion of subjects receiving rescue medication and median time to rescue medication
Phase 1: Systemic exposure to sunitinib measured in plasma level
Plasma levels of sunitinib (ng/mL)
Phase 1: Change from baseline in sub retinal hyper reflective material (SHRM) height
Subretinal hyper reflective material (SHRM) height
Phase 2: Proportion of subjects with absence of retinal fluid by SD-OCT
Assessment of retinal fluid by SD-OCT
Phase 2: Proportion of subjects with < 15 BCVA letter loss by ETDRS
Proportion of subjects with < 15 letters lost in BCVA measured by ETDRS method, baseline comparison to assessments at months 1-12
Phase 2: Proportion of subjects with ≥ 15 BCVA letters gained by ETDRS
Proportion of subjects with ≥ 15 letters gained in BCVA measured by ETDRS method, baseline comparison to assessments at months 1-12
Phase 2: Occurrence of ocular and nonocular adverse events (AEs)
Number of adverse events in total and number of subjects with an adverse event
Phase 2: Change from baseline in BCVA by ETDRS
Mean change from baseline in mean BCVA measured by early treatment
Phase 2: Systemic exposure to sunitinib measured in plasma level
Plasma levels of sunitinib (ng/mL)
Phase 2: Change from baseline in sub-retinal thickness
Mean change from baseline in sub-retinal thickness (microns) by SD-OCT
Phase 2: Rescue medication
Proportion of subjects receiving rescue medication and median time to rescue medication

Full Information

First Posted
August 2, 2017
Last Updated
December 18, 2019
Sponsor
Graybug Vision
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1. Study Identification

Unique Protocol Identification Number
NCT03249740
Brief Title
A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Neovascular (Wet) Age-related Macular Degeneration
Official Title
A Phase 1/2 Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of an Intravitreal Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Neovascular Age-related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
August 29, 2017 (Actual)
Primary Completion Date
September 13, 2018 (Actual)
Study Completion Date
January 16, 2019 (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

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and efficacy of single and repeated intravitreal injections of GB-102 in subjects with neovascular (wet) age-related macular degeneration.
Detailed Description
In this 2-part study, Part 1 is a multicenter, open-label, safety, tolerability, and systemic exposure evaluation to Sunitinib in escalating doses of a single IVT injection of GB-102, while Part 2 is a multicenter, double-masked, randomized (1:1:1), parallel-group, safety, and efficacy evaluation of repeated IVT injections of 2 dose levels of GB-102 compared with aflibercept.

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, Choroidal neovascularization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Phase 1: open-label GB-102 dose cohorts are initiated sequentially Phase 2: assignment to and initiation of cohorts occur in parallel - not completed in this study. Separate protocol (GBV-102-002) implemented for Phase 2.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Masking is relevant to Phase 2 only
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Phase 1 - GB-102
Arm Type
Experimental
Arm Description
Subjects will be assigned to 1 of 4 cohorts to receive a single intravitreal injection of up to 2.0 mg (50 μL) GB-102.
Arm Title
Experimental: Phase 2 - GB-102
Arm Type
Experimental
Arm Description
Low dose or high dose injected every 6 months
Arm Title
Active Comparator: Phase 2 - Aflibercept
Arm Type
Active Comparator
Arm Description
Aflibercept 2 mg injected every 2 months
Intervention Type
Drug
Intervention Name(s)
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)
Anti-VEGF
Intervention Description
Intravitreal injection of Aflibercept.
Primary Outcome Measure Information:
Title
Phase 1: Occurrence of ocular and nonocular adverse events (AEs)
Description
Number of adverse events in total and number of subjects with an adverse event
Time Frame
8 months
Title
Phase 2: Change from baseline in best corrected visual acuity by ETDRS
Description
Mean change from Baseline at Day 270 (Month 9) in best corrected visual acuity (BCVA) measured by early treatment diabetic retinopathy (ETDRS)
Time Frame
Baseline, Month 9
Secondary Outcome Measure Information:
Title
Phase 1: Change from baseline in BCVA by ETDRS
Description
Mean change from baseline in mean BCVA measured by early treatment diabetic retinopathy (ETDRS) method
Time Frame
8 months
Title
Phase 1: Change from baseline in sub-retinal thickness
Description
Mean change from baseline in sub-retinal thickness (microns) by spectral domain - optical coherence tomography (SD-OCT)
Time Frame
8 months
Title
Phase 1: Change from baseline in retinal fluid by SD-OCT
Description
Assessment of retinal fluid by SD-OCT
Time Frame
8 months
Title
Phase 1: Change from baseline in total lesion area by FA/CFP
Description
Lesion area (total) by fluorescein angiography/color fundus photography (FA/CFP)
Time Frame
8 months
Title
Phase 1: Change from baseline in CNV lesion area by FA/CFP
Description
CNV lesion area by FA/CFP
Time Frame
8 months
Title
Phase 1: Change from baseline in fluorescein leakage area by FA/CFP
Description
Area of fluorescein leakage by FA/CFP
Time Frame
8 months
Title
Phase 1: Rescue medication
Description
Proportion of subjects receiving rescue medication and median time to rescue medication
Time Frame
8 months
Title
Phase 1: Systemic exposure to sunitinib measured in plasma level
Description
Plasma levels of sunitinib (ng/mL)
Time Frame
8 months
Title
Phase 1: Change from baseline in sub retinal hyper reflective material (SHRM) height
Description
Subretinal hyper reflective material (SHRM) height
Time Frame
8 months
Title
Phase 2: Proportion of subjects with absence of retinal fluid by SD-OCT
Description
Assessment of retinal fluid by SD-OCT
Time Frame
12 months
Title
Phase 2: Proportion of subjects with < 15 BCVA letter loss by ETDRS
Description
Proportion of subjects with < 15 letters lost in BCVA measured by ETDRS method, baseline comparison to assessments at months 1-12
Time Frame
12 months
Title
Phase 2: Proportion of subjects with ≥ 15 BCVA letters gained by ETDRS
Description
Proportion of subjects with ≥ 15 letters gained in BCVA measured by ETDRS method, baseline comparison to assessments at months 1-12
Time Frame
12 months
Title
Phase 2: Occurrence of ocular and nonocular adverse events (AEs)
Description
Number of adverse events in total and number of subjects with an adverse event
Time Frame
12 months
Title
Phase 2: Change from baseline in BCVA by ETDRS
Description
Mean change from baseline in mean BCVA measured by early treatment
Time Frame
12 months
Title
Phase 2: Systemic exposure to sunitinib measured in plasma level
Description
Plasma levels of sunitinib (ng/mL)
Time Frame
12 months
Title
Phase 2: Change from baseline in sub-retinal thickness
Description
Mean change from baseline in sub-retinal thickness (microns) by SD-OCT
Time Frame
12 months
Title
Phase 2: Rescue medication
Description
Proportion of subjects receiving rescue medication and median time to rescue medication
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Males or females of any race, ≥ 50 years of age Presence of an active CNV lesion secondary to AMD treated with at least 3 monthly injections of an anti-VEGF agent (aflibercept, bevacizumab, or ranibizumab) Evidence of increased vascular permeability and/or loss of visual acuity Key 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, IOP, hypothyroidism, or hyperthyroidism Chronic renal disease Abnormal liver function Women who are pregnant or lactating
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles P. Semba, MD
Organizational Affiliation
Graybug Vision, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Retinal Consultants of Arizona
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85296
Country
United States
Facility Name
Retina-Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Midwest Eye Institute
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Ophthalmic Consultants of Long Island
City
Lynbrook
State/Province
New York
ZIP/Postal Code
11563
Country
United States
Facility Name
Retina Research Institute of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Texas Retina Associates
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Retina Research Center, PLLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Neovascular (Wet) Age-related Macular Degeneration

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