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Trial record 1 of 1 for:    graybug | Recruiting Studies | amd
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A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Neovascular (Wet) Age-related Macular Degeneration

This study is currently recruiting participants.
Verified August 2017 by Graybug Vision
Sponsor:
ClinicalTrials.gov Identifier:
NCT03249740
First Posted: August 15, 2017
Last Update Posted: August 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Graybug Vision
  Purpose
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.

Condition Intervention Phase
Neovascular Age-Related Macular Degeneration Drug: GB-102 Drug: Aflibercept Phase 1 Phase 2

Study Type: Interventional
Study Design: 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
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

Resource links provided by NLM:


Further study details as provided by Graybug Vision:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 482
Anticipated Study Start Date: August 2017
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: GB-102
Intravitreal injection of GB-102
Other Name: Sunitinib malate
Experimental: Experimental: Phase 2 - GB-102
Low dose or high dose injected every 6 months
Drug: GB-102
Intravitreal injection of GB-102
Other Name: Sunitinib malate
Active Comparator: Active Comparator: Phase 2 - Aflibercept
Aflibercept 2 mg injected every 2 months
Drug: Aflibercept
Intravitreal injection of Aflibercept.
Other Name: Anti-VEGF

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249740


Contacts
Contact: VP, Global Clinical Development Operations (650) 487-2800 vsmith@graybug.com

Locations
United States, Arizona
Retinal Consultants of Arizona Recruiting
Gilbert, Arizona, United States, 85296
United States, California
Retina Institute of California Recruiting
Arcadia, California, United States, 91007
Retina-Vitreous Associates Medical Group Recruiting
Beverly Hills, California, United States, 90211
United States, Indiana
Midwest Eye Institute Recruiting
Indianapolis, Indiana, United States, 46290
United States, Texas
Retina Research Institute of Texas Recruiting
Abilene, Texas, United States, 79606
Texas Retina Associates Recruiting
Arlington, Texas, United States, 76012
Sponsors and Collaborators
Graybug Vision
Investigators
Study Director: Charles P. Semba, MD Graybug Vision, Inc.
  More Information

Responsible Party: Graybug Vision
ClinicalTrials.gov Identifier: NCT03249740     History of Changes
Other Study ID Numbers: GBV-102-001
First Submitted: August 2, 2017
First Posted: August 15, 2017
Last Update Posted: August 30, 2017
Last Verified: August 2017

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
Choroidal neovascularization

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors