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A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Diabetic Macular Edema and Retinal Vein Occlusion

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ClinicalTrials.gov Identifier: NCT04085341
Recruitment Status : Recruiting
First Posted : September 11, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Graybug Vision

Brief Summary:
Phase 2a multicenter, open-label, parallel-arm design study to evaluate the safety, tolerability and pharmacodynamics of a single intravitreal injection comparing 2 dose levels of GB-102 on subjects with Diabetic Macular Edema and Retinal Vein Occlusion

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Retina Vein Occlusion Drug: GB-102 Phase 2

Detailed Description:
Phase 2a multicenter, open-label, parallel-arm design study to evaluate the safety, tolerability and pharmacodynamics of a single intravitreal injection comparing 2 dose levels (1 mg and 2 mg) of GB-102 on subjects with Diabetic Macular Edema and Retinal Vein Occlusion who have received prior treatment with anti-vascular endothelial growth factor (VEGF)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel-arm design
Masking: None (Open Label)
Masking Description: Open-label study design
Primary Purpose: Treatment
Official Title: A Phase 2a Multicenter Study Evaluating the Safety, Tolerability, and Pharmacodynamics of Sunitinib Malate Depot Formulation (GB-102) in Subjects With Diabetic Macular Edema (DME) and Retinal Vein Occlusion (RVO)
Actual Study Start Date : September 11, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: GB-102 Dose 1 (1 mg)
Participants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline.
Drug: GB-102
Intravitreal injection of GB-102
Other Name: Sunitinib malate

Experimental: GB-102 Dose 2 (2 mg)
Participants will receive intravitreal (IVT) GB-102 (2 mg) in the study eye at Baseline.
Drug: GB-102
Intravitreal injection of GB-102
Other Name: Sunitinib malate




Primary Outcome Measures :
  1. Occurrence of ocular and non-ocular adverse events (AEs) and serious adverse events at all study visits [ Time Frame: Baseline through Month 6 ]
    Number of adverse events in total and number of subjects with an adverse event


Secondary Outcome Measures :
  1. Mean change from baseline in BCVA (ETDRS) at all study visits [ Time Frame: Baseline through Month 6 ]

    BCVA = best corrected visual acuity; ETDRS = early treatment of diabetic retinopathy

    BCVA = 0 (worst) to 100 (best)

    Assessment of change in BCVA (ETDRS letter score) from baseline at all visits


  2. Mean change from baseline in CST (SD-OCT) at all study visits [ Time Frame: Baseline through Month 6 ]

    CST = central subfield thickness

    SD-OCT = spectral domain-optical coherence tomography

    Assessment of change in CST (μm) measurement from baseline at all visits


  3. Time to rescue treatment [ Time Frame: Baseline through Month 6 ]
    Assessment of time to rescue treatment over 6 months of treatment



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females ≥ 21 years of age
  • Known diagnosis of macular edema secondary to diabetic macular edema or retinal vein occlusion treated with at least 3 prior IVT injections of an anti-VEGF agent (aflibercept, bevacizumab, or ranibizumab)
  • Demonstrated response to prior anti-VEGF treatment since diagnosis
  • BCVA of 31 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 IOP
  • Chronic renal disease

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): NCT04085341


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

Locations
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United States, Arizona
Retinal Research Institute Recruiting
Phoenix, Arizona, United States, 85053
United States, Georgia
Southern Retina Recruiting
Savannah, Georgia, United States, 31405
United States, Kentucky
Eye Care Institute Recruiting
Louisville, Kentucky, United States, 40206
United States, Massachusetts
Boston Retina Recruiting
Boston, Massachusetts, United States, 02482
United States, Nevada
Sierra Eye Associates Recruiting
Reno, Nevada, United States, 89502
United States, Texas
Texoma Retina Center Recruiting
Denison, Texas, United States, 75020
Sponsors and Collaborators
Graybug Vision
Investigators
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Study Director: Chief Medical Officer Graybug Vision, Inc.

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Responsible Party: Graybug Vision
ClinicalTrials.gov Identifier: NCT04085341     History of Changes
Other Study ID Numbers: GBV-102-003
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Graybug Vision:
Macular Edema
Additional relevant MeSH terms:
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Macular Edema
Retinal Vein Occlusion
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action