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Completed

NCT Number: NCT03249740

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

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.

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Key information

Conditions

Neovascular Age-related Macular Degeneration Choroid Diseases Choroidal Neovascularization Eye Diseases Macular Degeneration Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Uveal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Retinal Consultants of Arizona, Gilbert, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

GB-102

Drug

Intravitreal injection of GB-102

Other names: Sunitinib malate

aflibercept

Drug

Intravitreal injection of Aflibercept.

Other names: Anti-VEGF

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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

  2. 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)

  3. Phase 1: Change from baseline in retinal fluid by SD-OCT

    Time frame: 8 months

    Assessment of retinal fluid by SD-OCT

  4. 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)

  5. Phase 1: Change from baseline in CNV lesion area by FA/CFP

    Time frame: 8 months

    CNV lesion area by FA/CFP

  6. Phase 1: Change from baseline in fluorescein leakage area by FA/CFP

    Time frame: 8 months

    Area of fluorescein leakage by FA/CFP

  7. Phase 1: Rescue medication

    Time frame: 8 months

    Proportion of subjects receiving rescue medication and median time to rescue medication

  8. Phase 1: Systemic exposure to sunitinib measured in plasma level

    Time frame: 8 months

    Plasma levels of sunitinib (ng/mL)

  9. Phase 1: Change from baseline in sub retinal hyper reflective material (SHRM) height

    Time frame: 8 months

    Subretinal hyper reflective material (SHRM) height

  10. Phase 2: Proportion of subjects with absence of retinal fluid by SD-OCT

    Time frame: 12 months

    Assessment of retinal fluid by SD-OCT

  11. 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

  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

  13. 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

  14. Phase 2: Change from baseline in BCVA by ETDRS

    Time frame: 12 months

    Mean change from baseline in mean BCVA measured by early treatment

  15. Phase 2: Systemic exposure to sunitinib measured in plasma level

    Time frame: 12 months

    Plasma levels of sunitinib (ng/mL)

  16. 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

  17. Phase 2: Rescue medication

    Time frame: 12 months

    Proportion of subjects receiving rescue medication and median time to rescue medication

Sponsors and collaborators

Lead sponsor

Graybug Vision

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 15, 2017
Registry last updated
Dec 20, 2019

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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