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

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ClinicalTrials.gov Identifier: NCT03249740
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Graybug Vision

Tracking Information
First Submitted Date  ICMJE August 2, 2017
First Posted Date  ICMJE August 15, 2017
Last Update Posted Date June 28, 2018
Actual Study Start Date  ICMJE August 29, 2017
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
  • Phase 1: Occurrence of ocular and nonocular adverse events (AEs) [ Time Frame: 8 months ]
    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 [ Time Frame: Baseline, Month 9 ]
    Mean change from Baseline at Day 270 (Month 9) in best corrected visual acuity (BCVA) measured by early treatment diabetic retinopathy (ETDRS)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03249740 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2017)
  • Phase 1: Change from baseline in BCVA by ETDRS [ Time Frame: 8 months ]
    Mean change from baseline in mean BCVA measured by early treatment diabetic retinopathy (ETDRS) method
  • Phase 1: Change from baseline in sub-retinal thickness [ Time Frame: 8 months ]
    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 [ Time Frame: 8 months ]
    Assessment of retinal fluid by SD-OCT
  • Phase 1: Change from baseline in total lesion area by FA/CFP [ Time Frame: 8 months ]
    Lesion area (total) by fluorescein angiography/color fundus photography (FA/CFP)
  • Phase 1: Change from baseline in CNV lesion area by FA/CFP [ Time Frame: 8 months ]
    CNV lesion area by FA/CFP
  • Phase 1: Change from baseline in fluorescein leakage area by FA/CFP [ Time Frame: 8 months ]
    Area of fluorescein leakage by FA/CFP
  • Phase 1: Rescue medication [ Time Frame: 8 months ]
    Proportion of subjects receiving rescue medication and median time to rescue medication
  • Phase 1: Systemic exposure to sunitinib measured in plasma level [ Time Frame: 8 months ]
    Plasma levels of sunitinib (ng/mL)
  • Phase 1: Change from baseline in sub retinal hyper reflective material (SHRM) height [ Time Frame: 8 months ]
    Subretinal hyper reflective material (SHRM) height
  • Phase 2: Proportion of subjects with absence of retinal fluid by SD-OCT [ Time Frame: 12 months ]
    Assessment of retinal fluid by SD-OCT
  • Phase 2: Proportion of subjects with < 15 BCVA letter loss by ETDRS [ Time Frame: 12 months ]
    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 [ Time Frame: 12 months ]
    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) [ Time Frame: 12 months ]
    Number of adverse events in total and number of subjects with an adverse event
  • Phase 2: Change from baseline in BCVA by ETDRS [ Time Frame: 12 months ]
    Mean change from baseline in mean BCVA measured by early treatment
  • Phase 2: Systemic exposure to sunitinib measured in plasma level [ Time Frame: 12 months ]
    Plasma levels of sunitinib (ng/mL)
  • Phase 2: Change from baseline in sub-retinal thickness [ Time Frame: 12 months ]
    Mean change from baseline in sub-retinal thickness (microns) by SD-OCT
  • Phase 2: Rescue medication [ Time Frame: 12 months ]
    Proportion of subjects receiving rescue medication and median time to rescue medication
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Neovascular (Wet) Age-related Macular Degeneration
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Phase 1: open-label GB-102 dose cohorts are initiated sequentially Phase 2: assignment to and initiation of cohorts occur in parallel
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
Masking is relevant to Phase 2 only
Primary Purpose: Treatment
Condition  ICMJE Neovascular Age-Related Macular Degeneration
Intervention  ICMJE
  • Drug: GB-102
    Intravitreal injection of GB-102
    Other Name: Sunitinib malate
  • Drug: Aflibercept
    Intravitreal injection of Aflibercept.
    Other Name: Anti-VEGF
Study Arms  ICMJE
  • Experimental: Experimental: Phase 1 - GB-102
    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.
    Intervention: Drug: GB-102
  • Experimental: Experimental: Phase 2 - GB-102
    Low dose or high dose injected every 6 months
    Intervention: Drug: GB-102
  • Active Comparator: Active Comparator: Phase 2 - Aflibercept
    Aflibercept 2 mg injected every 2 months
    Intervention: Drug: Aflibercept
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 31, 2018)
782
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2017)
482
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: VP, Global Clinical Development Operations (650) 487-2800 vsmith@graybug.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03249740
Other Study ID Numbers  ICMJE GBV-102-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Graybug Vision
Study Sponsor  ICMJE Graybug Vision
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Charles P. Semba, MD Graybug Vision, Inc.
PRS Account Graybug Vision
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP