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Completed

NCT Number: NCT04085341

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

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

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Key information

Conditions

Diabetic Macular Edema Eye Diseases Macular Degeneration Macular Edema Retina Vein Occlusion Retinal Degeneration Retinal Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Retinal Research Institute, Phoenix, Arizona, United States

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GB-102

Drug

Intravitreal injection of GB-102

Other names: Sunitinib malate

Primary outcomes

  1. Occurrence of Adverse Events (AEs) Across All Study Visits

    Time frame: Baseline through Month 6

    Number of subjects with an adverse event across all study visits

Secondary outcomes

  1. Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) (ETDRS) at All Study Visits

    Time frame: Baseline to 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 Central Subfield Thickness (CST) (SD-OCT) at All Study Visits

    Time frame: Baseline to 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

Sponsors and collaborators

Lead sponsor

Graybug Vision

Industry

Registry information

Official study 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)

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 11, 2019
Registry last updated
Nov 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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